| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| Evaluation of the Anti-inflammatory Effects of Glycopyrronium Added to Indacaterol/Mometasone on the Allergen-induced Late Asthmatic Response [NCT04259164] | Phase 3 | 28 participants (Actual) | Interventional | 2020-09-10 | Completed |
| A 1-Year Safety Study of Medium and High Doses of Mometasone Furoate/Formoterol Combination Formulation and Medium and High Doses of Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Medium to High Doses of Inhaled Glucocorticosteroi [NCT00379288] | Phase 3 | 404 participants (Actual) | Interventional | 2006-06-30 | Completed |
| Efficacy and Safety of Nasonex vs. Placebo in Subjects With SAR and Concomitant Asthma [NCT00070707] | Phase 4 | 188 participants (Actual) | Interventional | 2003-04-03 | Completed |
| A Multi-center, Randomized, 12-week Treatment, Doubleblind Study to Assess the Efficacy and Safety of QMF149 (150/80 Microgram) Compared With MF Twisthaler® (200 Microgram) in Adult and Adolescent Patients With Asthma [NCT02892344] | Phase 3 | 802 participants (Actual) | Interventional | 2017-01-16 | Completed |
| A Prospective, Randomised, Vehicle-Controlled, Double-Blind, Exploratory Clinical Trial To Assess The Efficacy And Steroid Sparing Potential Of DGLA Cream Topically Applied To Patients With Moderate To Severe Atopic Dermatitis [NCT03676036] | Phase 2 | 42 participants (Actual) | Interventional | 2015-06-30 | Completed |
| A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids [NCT02898454] | Phase 3 | 448 participants (Actual) | Interventional | 2016-11-28 | Completed |
| A Comparison of Patients on AVAMYS ® Versus NASONEX (A Trade Mark of Schering Corporation) and FLIXONASE ® on Key Health Outcome Measures [NCT01199757] | | 540 participants (Actual) | Observational | 2009-07-10 | Completed |
| A Randomized, 26-Week, Placebo-Controlled Efficacy and Safety Study With a 26-Week Long-Term Safety Extension, of High- and Medium-Dose Inhaled Mometasone Furoate/Formoterol Fixed-Dose Combination Formulation Compared With Formoterol and High-Dose Inhaled [NCT00383721] | Phase 3 | 1,196 participants (Actual) | Interventional | 2006-09-30 | Completed |
| Open Label, 12-week Clinical Trial to Assess Efficacy, Safety, Treatment Adherence and Quality of Life Impact of Mometasone Furoate Dry Powder 400 mcg Once-daily in Persistent Mild-moderate Asthmatic Patients at Least 12 Years Old [NCT00687531] | Phase 4 | 385 participants (Actual) | Interventional | 2006-11-30 | Terminated |
| Personalized Treatment Algorithms for Difficult-to-treat Asthma: Bench to Community [NCT04179461] | Phase 2 | 21 participants (Actual) | Interventional | 2018-03-16 | Completed |
| An Exploratory, Double-blind, Placebo-controlled Study of the Effects of Dupilumab on Airway Inflammation of Adults With Persistent Asthma [NCT02573233] | Phase 2 | 42 participants (Actual) | Interventional | 2016-01-27 | Completed |
| A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids [NCT02912468] | Phase 3 | 276 participants (Actual) | Interventional | 2016-12-05 | Completed |
| A Randomised, Double-blind, Parallel Group PhIII Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab as an Add on to Maintenance Treatment in Adults With Severe Bilateral Nasal Polyps - SYNAPSE (StudY in NAsal Polyps Patients to Asse [NCT03085797] | Phase 3 | 414 participants (Actual) | Interventional | 2017-05-25 | Completed |
| Comparison of Daily Mometasone Furoate Nasal Spray Alone Versus a Combination With Montelukast for Treatment of Chronic Rhinosinusitis With Asthma After Functional Endoscopic Sinus Surgery: a 9-month Randomized, Open-label, Controlled Study [NCT02110654] | Phase 4 | 50 participants (Actual) | Interventional | 2014-06-30 | Completed |
| A Randomized, 26-Week, Placebo-Controlled Efficacy and Safety Study With a 26-Week Long-Term Safety Extension, of High- and Medium-Dose Inhaled Mometasone Furoate/Formoterol Fixed-Dose Combination Formulation Compared With Formoterol and High-Dose Inhaled [NCT00383435] | Phase 3 | 1,055 participants (Actual) | Interventional | 2006-10-31 | Completed |
| A 12-Week Efficacy and Safety Study of Two Doses of Mometasone Furoate/Formoterol Combination Formulation Compared With Mometasone Furoate Monotherapy, in Persistent Asthmatics Previously Treated With High-Dose Inhaled Glucocorticosteroids [NCT00381485] | Phase 3 | 834 participants (Actual) | Interventional | 2006-07-01 | Completed |
| A Study of the Therapeutic Equivalency of MF DPI 100 mcg and 200 mcg Inhalers in Corticosteroid-Dependent Subjects With Moderate Asthma [NCT00521599] | Phase 4 | 672 participants (Actual) | Interventional | 2007-05-31 | Completed |
| Comparative Study of the Effect of Two Doses of Mometasone Furoate Dry Powder Inhaler 200 mcg and 400 mcg QD PM, Fluticasone Propionate 250 mcg BID, and Montelukast 10 mg QD PM, on Bone Mineral Density in Adults With Asthma [NCT00394355] | Phase 4 | 566 participants (Actual) | Interventional | 2006-09-30 | Completed |
| Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury [NCT01353599] | Phase 1 | 50 participants (Anticipated) | Interventional | 2011-08-31 | Active, not recruiting |
| A Phase III, Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis With Eurofarma Mometasone or Reference Mometasone. [NCT01372865] | Phase 3 | 364 participants (Actual) | Interventional | 2012-06-30 | Completed |
| Efficacy of Intranasal Steroid for Children With Sleep-Disordered Breathing Non-Responsive to Initial Treatment With Intranasal Saline: A Randomized Trial [NCT05382494] | Phase 4 | 154 participants (Anticipated) | Interventional | 2022-12-05 | Recruiting |
| A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma [NCT02554786] | Phase 3 | 2,216 participants (Actual) | Interventional | 2015-12-29 | Completed |
| A Phase III, Randomized, Active-Controlled, Parallel-Group Clinical Trial to Study the Efficacy and Long-Term Safety of Mometasone Furoate/Formoterol Fumarate (MF/F, MK-0887A [SCH418131]), Compared With Mometasone Furoate (MF, MK-0887 [SCH032088]), in Chi [NCT02741271] | Phase 3 | 181 participants (Actual) | Interventional | 2016-05-11 | Completed |
| An Open-Label, Comparative, Randomized, Parallel, Multicenter Study to Determine the Efficacy and Safety of Two Dry Powder Inhalers (DPIs) Used for the Application of Mometasone in the Treatment of Asthma [NCT00817817] | Phase 3 | 93 participants (Actual) | Interventional | 2002-10-01 | Completed |
| A Two-Part, Randomized, Placebo-Controlled, Crossover Trial to Evaluate the Differential Effects of Inhaled Nedocromil, Oral Montelukast, and Inhaled Mometasone on Markers of the Early Airway Response to Allergen in Asthmatics [NCT01061333] | Phase 1 | 16 participants (Actual) | Interventional | 2010-06-30 | Completed |
| A Randomized, Evaluator-Blind, Crossover, Single Dose Study of the Bronchodilator Effect of Formoterol Fumarate in Combination With Mometasone Furoate Metered Dose Inhaler Delivered With and Without a Spacer Versus Placebo and Foradil® Aerolizer® in Child [NCT01258803] | Phase 2 | 92 participants (Actual) | Interventional | 2010-12-31 | Completed |
| Use of Mometasone Eluting Stent in Choanal Atresia [NCT03605537] | Phase 4 | 0 participants (Actual) | Interventional | 2018-07-03 | Withdrawn(stopped due to Study terminated due to lack of funding.) |
| A Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Investigate Etokimab (ANB020) in Adult Subjects With Chronic Rhinosinusitis With Nasal Polyposis [NCT03614923] | Phase 2 | 105 participants (Actual) | Interventional | 2018-11-29 | Completed |
| Evaluation of the Sensitivity of Pharmacokinetics to Differences in the Particle Size Distribution of Two Different Formulations of a Locally-acting Mometasone Furoate Suspension-based Nasal Spray [NCT02588326] | Phase 1 | 80 participants (Actual) | Interventional | 2018-09-21 | Completed |
| An Open-label, Single-Dose, Three-way Crossover Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents (12 to 17 Years of Age) and Young Adults (18 to [NCT05887843] | Phase 1 | 38 participants (Actual) | Interventional | 2023-06-08 | Terminated(stopped due to Business decision (no safety concerns).) |
| Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study in 98 Boys [NCT01108198] | Phase 4 | 100 participants (Anticipated) | Interventional | 2006-10-31 | Recruiting |
| A 26-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate/Formoterol Fumarate Combination Formulation Compared With Mometasone Furoate and Formoterol Monotherapy in Subjects With Persistent Asthma Previously Treated With Low-Dose Inhale [NCT00383552] | Phase 3 | 746 participants (Actual) | Interventional | 2006-09-30 | Completed |
| A Double-Blind Placebo-Controlled, Randomized, Parallel-Group, Single-Site Study of Mometasone Furoate Nasal Spray (MFNS) In Subjects With Sleep-disordered Breathing Associated With Perennial Allergic Rhinitis (PAR) Using Home-Monitored Cardio-Respiratory [NCT00359216] | Phase 4 | 30 participants (Actual) | Interventional | 2006-05-31 | Completed |
| A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study Of Benralizumab in Patients With Severe Nasal Polyposis [NCT03401229] | Phase 3 | 413 participants (Actual) | Interventional | 2018-01-15 | Completed |
| Effects of the Direct Interaction Between Streptococcus Salivarius 24SMBc and Streptococcus Oralis 89a With the Respiratory Epithelium in Children Affected by Allergic Rhinoconjunctivitis [NCT03449836] | Phase 3 | 60 participants (Anticipated) | Interventional | 2018-03-01 | Not yet recruiting |
| Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis [NCT03705793] | Phase 4 | 53 participants (Actual) | Interventional | 2019-01-01 | Completed |
| Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old [NCT00378378] | Phase 3 | 127 participants (Actual) | Interventional | 2006-07-31 | Completed |
| Comparison the Efficacy and Safety of 0.1% Tacrolimus Ointment With 0.1% Mometasone Furoate Cream in the Treatment of Adult Vitiligo: A Single Blinded Pilot Study [NCT01333410] | Phase 4 | 30 participants (Anticipated) | Interventional | 2009-06-30 | Active, not recruiting |
| A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Nasal Spray (Lek Pharmaceuticals) With NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms o [NCT01038427] | Phase 3 | 795 participants (Actual) | Interventional | 2009-12-02 | Completed |
| Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR) [NCT00728416] | Phase 3 | 333 participants (Actual) | Interventional | 2008-08-31 | Completed |
| Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis [NCT00720382] | Phase 3 | 703 participants (Actual) | Interventional | 2007-03-31 | Completed |
| A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With Persistent Asthma [NCT00941798] | Phase 2 | 2,283 participants (Actual) | Interventional | 2009-07-31 | Completed |
| A Randomized, Open Label Study to Assess the Effects of a Nasal Corticosteroid on the Pharmacokinetics, Safety, and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg [NCT00662883] | Phase 1 | 18 participants (Actual) | Interventional | 2007-11-30 | Completed |
| Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma [NCT00666679] | Phase 2 | 134 participants (Actual) | Interventional | 2008-05-31 | Completed |
| A Long-term Study of Mometasone Furoate in Patients With Perennial Allergic Rhinitis [NCT00732368] | Phase 3 | 98 participants (Actual) | Interventional | 2005-05-01 | Completed |
| A Preference Evaluation of Nasonex® Nasal Spray (Unscented) vs. Flonase® Nasal Spray (Scented) in Subjects With Symptomatic Allergic Rhinitis (AR) - Single-Dose Cross-over [NCT00783458] | Phase 4 | 100 participants (Actual) | Interventional | 2004-12-01 | Completed |
| The Pathogenic Role Of Staphylococcus Aureus And The Skin Microbiome During Flare And Resolution Of Atopic Dermatitis [NCT05578482] | Phase 4 | 45 participants (Anticipated) | Interventional | 2022-10-24 | Recruiting |
| The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study [NCT03491098] | Early Phase 1 | 60 participants (Anticipated) | Interventional | 2018-05-15 | Not yet recruiting |
| A Randomized Trial Assessing the Chronobiology of Once Daily Administration of Mometasone Furoate DPI in Patients With Asthma [NCT00835094] | Phase 4 | 216 participants (Actual) | Interventional | 2002-10-01 | Completed |
| Randomized, Double-blind, Cross-over Clinical Trial to Assess Onset of Action and Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in an Environmental Exposure Unit in Comparison to Pla [NCT06126952] | Phase 2 | 84 participants (Anticipated) | Interventional | 2023-10-30 | Recruiting |
| Characterisation and Intervention Study in Patients With Long-term Use of Nasal Decongestants [NCT04898764] | Phase 4 | 135 participants (Anticipated) | Interventional | 2020-10-21 | Recruiting |
| A Randomized, Placebo-controlled, Double-blind Trial Evaluating the Efficacy, Tolerability and Safety of ESO-101 in Adult Patients With Active Eosinophilic Esophagitis [NCT04849390] | Phase 2 | 43 participants (Actual) | Interventional | 2021-06-29 | Completed |
| Study on the Efficacy and Safety of Bencycloquidium Bromide Nasal Spray Alone or in Combination With Mometasone Furoate Aqueous Nasal Spray in the Treatment of Moderate-severe Persistent Allergic Rhinitis [NCT05038202] | Phase 4 | 450 participants (Anticipated) | Interventional | 2021-06-16 | Recruiting |
| Treatment of Eosinophilic Esophagitis With Mometason Furoat Aerosol: a Randomised, Placebo-controled Phase II Study for Evaluation of Treatment Effect on Group Level Including Symtom Questionnaires [NCT02113267] | Phase 2 | 40 participants (Actual) | Interventional | 2014-04-30 | Terminated(stopped due to Combination slow recruitment, short shelf life for placebo and insufficient funding for further drug production (probably anyway sufficient number included).) |
| Role of Corticosteroid Nasal Spray in Recovery of Smell Sensation in COVID-19 Patients [NCT04484493] | Phase 3 | 100 participants (Actual) | Interventional | 2020-08-08 | Completed |
| A Randomized, Double-Blind, Multiple-Dose Trial of Mometasone Nasal Spray, 50 μg (Mylan), Nasonex® Nasal Spray, 50 μg (MSD-US), Nasonex® Nasal Spray Suspension, 50 μg (MSD-EU) & Placebo for Treatment of the Signs & Symptoms of Seasonal Allergic Rhinitis i [NCT02109185] | Phase 1 | 1,307 participants (Actual) | Interventional | 2013-09-30 | Completed |
| A Single-Blind, Randomized, Positive-controlled Study to Compare Monotherapy With an Inhaled Corticosteroid (Mometasone) to Combination Therapy With an Inhaled Corticosteroid + a Long-Acting Bronchodilator (Advair) in Patients With Milder Persistent Asthm [NCT00461812] | Phase 4 | 33 participants (Actual) | Interventional | 2007-04-30 | Terminated(stopped due to by sponsor due to failure to recruit patients who had mild persistent asthma who were not already on Advair 250/50 or 500/50.) |
| A Phase I, Single-Center, Randomized, Vehicle-Controlled Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers [NCT00721331] | Phase 1 | 20 participants (Anticipated) | Interventional | 2008-07-31 | Completed |
| A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety and Tolerability of 14-days Treatment With an Inhaled Dose of QMF149 (500/800) in Mild to Moderate Asthmatic Patients [NCT00605306] | Phase 2 | 28 participants (Actual) | Interventional | 2008-01-31 | Completed |
| Safety and Efficacy of SCH 32088 vs Beclomethasone Dipropionate (Vancenase AQ) and Placebo in Seasonal Allergic Rhinitis [NCT03855189] | Phase 3 | 345 participants (Actual) | Interventional | 1993-08-23 | Completed |
| Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis [NCT00453063] | Phase 3 | 426 participants (Actual) | Interventional | 2007-03-31 | Completed |
| Phase III Randomized Double-Blind Study of Mometasone Furoate Versus Placebo in the Prevention of Radiation Dermatitis in Breast Cancer Patients Receiving Radiation Therapy [NCT00438659] | Phase 3 | 176 participants (Actual) | Interventional | 2007-08-31 | Completed |
| Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis) [NCT01082393] | Phase 4 | 14 participants (Actual) | Interventional | 2010-02-16 | Completed |
| A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243) in Adult Subjects With a History of Grass Pollen Induced Rhinoconjunctivitis Wit [NCT00562159] | Phase 3 | 439 participants (Actual) | Interventional | 2007-11-30 | Completed |
| Comparison of Methylprednisolone or Methotrexate With Standard Treatment in the Maintenance Treatment of Medically and Surgically Treated Chronic Rhinosinusitis With Nasal Polyposis [NCT04532736] | Phase 2 | 41 participants (Actual) | Interventional | 2017-09-02 | Completed |
| The PIO III Study: In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery [NCT02687438] | | 20 participants (Actual) | Interventional | 2015-12-31 | Completed |
| Topical Corticosteroid and Bacterial Decolonization to Prevent Radiation Dermatitis: A Randomized Controlled Trial and Quality of Life Assessment [NCT05505214] | Phase 2 | 0 participants (Actual) | Interventional | 2023-09-01 | Withdrawn(stopped due to Study planned but never formally submitted to the IRB) |
| An Open-label, Two-period, Single-sequence, Crossover Study to Compare the Systemic Exposure of a Single Inhaled Dose of Mometasone Furoate (MF) When Administered Alone Via the MF Twisthaler® (TH) to a Single Inhaled Dose of QMF149 Indacaterol Acetate/MF [NCT04589663] | Phase 2 | 24 participants (Actual) | Interventional | 2021-06-07 | Completed |
| Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in the Treatment of Seasonal Allergic Rhinitis (Study No. C94-145) [NCT03855228] | Phase 3 | 704 participants (Actual) | Interventional | 1995-03-01 | Completed |
| A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study Using Subjective and Objective Measures to Evaluate the Clinical Efficacy of Mometasone Furoate Nasal Spray (MFNS) Following Initial and Maintenance Dosing in Subjects With Allergen-Indu [NCT00491504] | Phase 4 | 310 participants (Actual) | Interventional | 2007-02-28 | Completed |
| Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis [NCT00468312] | Phase 3 | 429 participants (Actual) | Interventional | 2007-03-31 | Completed |
| Validation of a Rhinitis Control Tool : the Rhinitis Control Scoring System (RCSS) [NCT00967967] | | 50 participants (Anticipated) | Interventional | 2009-03-31 | Suspended(stopped due to Awaiting results from sub analysis to decide if study continuesé) |
| A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Multicenter Study of Mometasone Furoate Nasal Spray on Sleep Disturbances and Daytime Somnolence in Subjects With Symptomatic Seasonal Allergic Rhinitis [NCT00358527] | Phase 4 | 401 participants (Actual) | Interventional | 2006-05-31 | Completed |
| An Open-label Study to Assess the Effects of Allergic Rhinitis and Coadministration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine [NCT02154334] | Phase 1 | 47 participants (Actual) | Interventional | 2014-06-30 | Completed |
| An Exploratory Study of Mometasone Furoate Nasal Spray in Patients With Moderate-severe Persistent Allergic Rhinitis and Intermittent Asthma: Effects on the Quality of Life Evaluated With the Rhinasthma Questionnaire [NCT00599027] | Phase 3 | 51 participants (Actual) | Interventional | 2008-05-31 | Completed |
| Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR) [NCT00733005] | Phase 3 | 324 participants (Actual) | Interventional | 2008-07-31 | Completed |
| Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR) [NCT00732381] | Phase 3 | 351 participants (Actual) | Interventional | 2008-08-31 | Completed |
| A Randomized, Partially-blinded, Placebo-controlled, Two-way Crossover, Proof of Concept Study to Compare the Relative Efficacy of CRTh2 Receptor Antagonist, QAV680 Against Placebo in the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber [NCT00784732] | Phase 2 | 44 participants (Actual) | Interventional | 2008-09-30 | Completed |
| Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis [NCT00783224] | Phase 3 | 351 participants (Actual) | Interventional | 2005-09-30 | Completed |
| "A Comparative Study of The Efficacy and Tolerability of Maintenance Treatment of Patients With Mild/Moderate Persistent Asthma With Asmanex Twisthaler 220 mcg QD PM Versus Asmanex Placebo QD PM" [NCT00442351] | Phase 4 | 26 participants (Actual) | Interventional | 2006-09-30 | Terminated(stopped due to Slow Enrollment) |
| A Randomized, Double-blind, Double-dummy, Multi-centre, 4-way Cross-over Study to Compare the Single Dose Bronchodilatory Effect of Formoterol Fumarate in Combination With Mometasone Furoate Delivered Via Pressurized Metered Dose Inhaler (pMDI) to Placebo [NCT00746330] | Phase 2 | 32 participants (Actual) | Interventional | 2008-08-31 | Completed |
| The Effects of Mometasone on Markers of Airway Inflammation [NCT00711165] | Phase 4 | 12 participants (Actual) | Interventional | 2005-08-31 | Completed |
| "Real Life Proof-of-Concept Study to Assess the Effect of Methylcellulose as add-on Seal to the In-season Pharmacologic Rescue Treatment in Subjects With Allergic Rhinitis" [NCT02557269] | Phase 4 | 60 participants (Actual) | Interventional | 2015-05-31 | Active, not recruiting |
| Inhaled Mometasone to Promote Reduction in Vasoocclusive Events 2 [NCT03758950] | Phase 2 | 80 participants (Actual) | Interventional | 2018-11-29 | Completed |
| A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Nasal Polyps (Protocol No. P05604) [NCT01386125] | Phase 3 | 748 participants (Actual) | Interventional | 2011-06-30 | Completed |
| Bioequivalence of Three Mometasone Furoate 0.1% Topical Lotions [NCT00805155] | | 80 participants (Actual) | Observational | 2004-02-29 | Completed |
| Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No.P06332) [NCT01135134] | Phase 3 | 333 participants (Actual) | Interventional | 2010-06-30 | Completed |
| Clinical Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray [NCT00779740] | Phase 3 | 102 participants (Actual) | Interventional | 2005-02-01 | Completed |
| Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children [NCT02541760] | Phase 3 | 143 participants (Actual) | Interventional | 2014-04-30 | Completed |
| Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children [NCT01098071] | Phase 4 | 34 participants (Actual) | Interventional | 2008-08-01 | Completed |
| A Single-Center, Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Activity of CRx-191 in Reducing the Psoriatic Infiltrate Band Thickness in Plaque Psoriasis [NCT00557739] | Phase 2 | 20 participants (Anticipated) | Interventional | 2007-11-30 | Completed |
| A Phase I, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability Profile of Topical Cream SNG100 for 14 Days of Treatment in Moderate Atopic Dermatitis Subjects. [NCT04615962] | Phase 1 | 66 participants (Anticipated) | Interventional | 2021-01-01 | Not yet recruiting |
| A Blinded, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg (Amneal Pharmaceuticals LLC) With NASONEX® Nasal Spray (Schering Corporation) in the Relief of the [NCT02125253] | Phase 3 | 811 participants (Actual) | Interventional | 2014-01-31 | Completed |
| A Preference Evaluation of Nasonex® Nasal Spray (Unscented) vs. Flonase® Nasal Spray (Scented) in Subjects With Symptomatic Allergic Rhinitis (AR) - Single-Dose Cross-over [NCT00817050] | Phase 4 | 100 participants (Actual) | Interventional | 2004-12-01 | Completed |
| Combination Therapy With Mometasone Furoate and Oxymetazoline in the Treatment of Adenoid Hypertrophy Concomitant With Allergic Rhinitis [NCT02559440] | Phase 4 | 240 participants (Actual) | Interventional | 2014-02-28 | Completed |
| Dose-Ranging Study of Mometasone Furoate Nasal Spray (SCH 32088) in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (Protocol C95-161) [NCT03879772] | Phase 3 | 679 participants (Actual) | Interventional | 1996-03-12 | Completed |
| Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Childrens [NCT02953366] | Phase 3 | 0 participants (Actual) | Interventional | 2019-05-31 | Withdrawn(stopped due to Sponsor decision) |
| An Open-label, Comparative, Randomized, Parallel, Multicenter Study to Determine the Efficacy and Safety of Two Dry Powder Inhalers (DPIs) Used for the Application of Mometasone in the Treatment of Asthma [NCT00975741] | Phase 3 | 97 participants (Actual) | Interventional | 2002-10-31 | Completed |
| Efficacy and Safety of New Mometasone Furoate Nasal Spray Formulation in Acute Rhinosinusitis Patients: A Randomized Clinical Trial [NCT05639959] | | 20 participants (Actual) | Observational [Patient Registry] | 2022-09-10 | Completed |
| Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion (OME) Compared to That of Combination of Antibiotic, Antihistaminic, and Nasal Decongestant [NCT03590912] | Phase 4 | 160 participants (Actual) | Interventional | 2018-09-05 | Completed |
| An Open-Label, Multi-Center, Patient Handling Study of Mometasone Furoate/Formoterol Fumarate MDI With an Integrated Dose Counter in Adolescent and Adult Subjects and Adult With Asthma or COPD [NCT00604500] | Phase 3 | 272 participants (Actual) | Interventional | 2008-03-01 | Completed |
| A Phase I, Single-Center, Randomized, Vehicle and Active-Controlled Study to Assess and Compare the Atrophy-Causing Potential of Topical CRx-191 Formulations in Healthy Volunteers [NCT00544687] | Phase 1 | 20 participants (Actual) | Interventional | 2007-09-30 | Completed |
| Efficacy and Safety of Mometasone Furoate Aqueous Nasal Spray vs Placebo and Flonase® (Fluticasone Propionate) in Seasonal Allergic Rhinitis Patients (I94-001) [NCT03882047] | Phase 3 | 313 participants (Actual) | Interventional | 1994-08-11 | Completed |
| A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg BID Delivered by Pressurized Metered-Dose Inhaler in Pe [NCT00424008] | Phase 3 | 722 participants (Actual) | Interventional | 2007-04-30 | Completed |
| Potential for Cortisol Suppression With the Use of High Volume Nasal Mometasone Irrigations in Varying Dosages. [NCT03979209] | Phase 1 | 45 participants (Anticipated) | Interventional | 2018-08-23 | Active, not recruiting |
| A 26-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate/Formoterol Fumarate Combination Formulation Compared With Mometasone Furoate and Formoterol Monotherapy in Subjects With Persistent Asthma Previously Treated With Medium-Dose Inh [NCT00383240] | Phase 3 | 781 participants (Actual) | Interventional | 2006-09-30 | Completed |
| A Randomized, Open Label, Active Controlled (Mometasone Furoate Aqueous Nasal Spray [Nasonex®] 200mcg QD), Parallel Group, Multi-Center, 52-Week Study to Assess the Long Term Safety of GW685698X Aqueous Nasal Spray 100mcg QD Via Nasal Biopsy in Subjects 1 [NCT00224523] | Phase 3 | 125 participants (Actual) | Interventional | 2005-09-30 | Completed |
| A Multicenter, Randomized, Double-blind, Placebo and Active Controlled Parallel-group Trial to Assess the Efficacy and Safety of the Fixed Combination Medicinal Product Mometasone Furoate + Azelastine Hydrochloride Nasal Spray (50 + 140 mcg) in the Treatm [NCT05311475] | Phase 3 | 669 participants (Actual) | Interventional | 2022-04-04 | Completed |
| A Comparison of Mometasone Furoate DPI Versus Budesonide DPI in Mild Persistent and Moderate Persistent Asthmatic Patients [NCT00442117] | Phase 3 | 180 participants (Actual) | Interventional | 2007-06-30 | Completed |
| Onset of Action of Mometasone Furoate (SCH 32088) Nasal Spray 50 mcg/Spray vs Placebo in Seasonal Allergic Rhinitis (Study No. C93-184). [NCT03861559] | Phase 3 | 201 participants (Actual) | Interventional | 1994-03-30 | Completed |
| A Study of Long-term (12-24 Weeks) Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No. P06333) [NCT01165424] | Phase 3 | 80 participants (Actual) | Interventional | 2010-04-30 | Completed |
| Study of Asthma and Nasal Steroids for the American Lung Association-Airways Clinical Research Centers [NCT01118312] | Phase 4 | 388 participants (Actual) | Interventional | 2010-09-30 | Completed |
| Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation [NCT00903721] | | 3,806 participants (Actual) | Observational | 2008-11-30 | Completed |
| Dose Finding and Dose Regimen Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis [NCT00779545] | Phase 2 | 455 participants (Actual) | Interventional | 2004-04-08 | Completed |
| A Multicenter Study of Establishing the Multi-disciplinary Cooperative Diagnosis and Treatment Process and Evaluation System for Children With Sleep Disordered Breathing and Malocclusion [NCT03451318] | | 400 participants (Anticipated) | Interventional | 2018-03-02 | Recruiting |
| A 12-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate Monotherapy in Subjects With Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids [NCT01026870] | Phase 3 | 0 participants (Actual) | Interventional | 2012-06-30 | Withdrawn |
| Intranasal Steroids for the Treatment of Nocturnal Enuresis With Associated Obstructive Sleep Apnea [NCT01861145] | Phase 4 | 0 participants (Actual) | Interventional | 2013-05-31 | Withdrawn(stopped due to Unable to sufficiently enroll or collect follow-up) |
| Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Adults [NCT02953379] | Phase 3 | 0 participants (Actual) | Interventional | 2019-05-31 | Withdrawn(stopped due to Sponsor decision) |
| Psychometric Evaluation of a Novel Questionnaire Designed to Assess Patient Satisfaction With and Preference of Intranasal Corticosteroids Administered Via HFA Aerosol or Aqueous Suspension Used for the Treatment of Allergic Rhinitis [NCT01287364] | Phase 3 | 185 participants (Actual) | Interventional | 2011-02-28 | Completed |
| Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation:A Randomized Trial, Double Blind Trial [NCT01856543] | Phase 3 | 143 participants (Actual) | Interventional | 2013-05-31 | Completed |
| CLINICAL EVALUATION OF EFFECTIVENESS OF ASSOCIATION MOMETASONE FUROATE 0.1% AND SALICYLIC ACID 5% COMPARED WITH 0.1% MOMETASONE FUROATE INSULATED TOPICAL USE OF LABORATORY Glenmark Pharmaceuticals Ltd, IN PATIENTS WITH PSORIASIS IN PLATE [NCT01228656] | Phase 2 | 40 participants (Actual) | Interventional | 2006-09-30 | Suspended |
| Phase IV Clinical Study,Comparative, Blind Double and Randomized to Compare Mometasone Furoate Cream (TOPISON) Versus Other Two Cream Mometasone Furoate, in Participants With Atopic Dermatitis [NCT04271007] | Phase 4 | 32 participants (Actual) | Interventional | 2020-11-23 | Completed |
| Efficacy and Safety of 200 mcg QD or 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) vs Amoxicillin vs Placebo as Primary Treatment of Subjects With Acute Rhinosinusitis [NCT00750750] | Phase 2 | 981 participants (Actual) | Interventional | 2003-01-01 | Completed |
| A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Mometasone Furoate/Azelastine Hydrochloride Combination Group and Mometasone Furoate and Azelastine Hydrochloride Group 4 Weeks After Treatment, Each Treatment Group Comparisons for Evaluation of Ef [NCT01470053] | Phase 3 | 347 participants (Actual) | Interventional | 2011-03-31 | Completed |
| Efficacy of Tofacitinib in Vitiligo-a Randomized Controlled Trial in a Selected Tertiary Level Hospital in Dhaka [NCT05293119] | Early Phase 1 | 80 participants (Anticipated) | Interventional | 2022-05-30 | Not yet recruiting |
| Acute Effect of Mometasone Furoate DPI on Beta-adrenergic Airway and Airway Vascular Relaxation in Moderately Severe Asthma [NCT01210170] | | 22 participants (Actual) | Interventional | 2010-10-31 | Completed |
| A Phase 1, Open Label, Two Period, Randomized, Cross Over Scintigraphy Study Assessing Nasal Deposition of a Single Dose of a Ciclesonide Radiolabeled Solution Following Nasal Inhalation of a Novel Nasal Metered Dose Inhaler (MDI) and of a Mometasone Furo [NCT01371786] | Phase 1 | 14 participants (Actual) | Interventional | 2011-06-30 | Completed |
| A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No [NCT01471340] | Phase 4 | 11,744 participants (Actual) | Interventional | 2012-01-09 | Completed |
| A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Furoate Anhydrous, 50 Mcg/Actuation Nasal Spray (Teva Pharmaceuticals USA) Compared to Nasonex® (Mometasone Furoate Monohydr [NCT01523236] | Phase 1/Phase 2 | 800 participants (Actual) | Interventional | 2011-12-31 | Completed |
| An Exploratory Safety Study of 480 Biomedical Sinus Drug Depot in Adult Subjects With Chronic Sinusitis [NCT02967731] | Phase 1 | 20 participants (Actual) | Interventional | 2017-06-06 | Completed |
| Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis [NCT00361439] | Phase 4 | 17 participants (Actual) | Interventional | 2006-08-31 | Terminated(stopped due to Study stopped early due to slow accrual.) |
| A Multi-center, Randomized, Double-blind, Double Dummy, Placebo and Active Controlled Crossover Study, to Investigate the 24 Hour FEV1 Profile of a Single Dose of QMF TWISTHALER Device in Adult Patients With Persistent Asthma [NCT00557440] | Phase 2 | 37 participants (Actual) | Interventional | 2007-11-30 | Completed |
| Efficacy of Azelastine and Mometasone Irrigation in Comparison to Nasal Sprays in Patients With Chronic Rhinitis [NCT05626621] | Phase 4 | 81 participants (Anticipated) | Interventional | 2022-11-23 | Recruiting |
| Safety and Efficacy of Carbon Dioxide（CO2）Fractional Laser Combined With Photodynamic Therapy in the Treatment of Female Vulvar Lichen Sclerosus [NCT05228483] | | 134 participants (Anticipated) | Interventional | 2021-11-23 | Recruiting |
| Stress and Treatment Response in Puerto Rican Children With Asthma [NCT03134755] | | 249 participants (Actual) | Observational | 2018-05-15 | Completed |
| Double Blind, Placebo Controlled Trial, Evaluating the Role of Nasonex® in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children [NCT00553891] | Phase 4 | 0 participants (Actual) | Interventional | 2006-05-31 | Withdrawn(stopped due to No enrollment because of war in the study country.) |
| A Clinical Evaluation of the Safety and Performance of the Steroid-Releasing S8 Sinus Implant When Used in Post-Sinus Surgery Patients With Recurrent Sinus Polyps [NCT01894503] | Phase 2 | 5 participants (Actual) | Interventional | 2013-06-30 | Completed |
| An Open-label Study to Identify Molecular Markers of Steroid Resistance in Nasal Polyposis Before and Following Treatment With Mometasone Furoate (MFNS) 2 Sprays/Nostril (100 mcg/Nostril) Twice Daily for 4 Weeks. [NCT01616160] | Phase 4 | 11 participants (Actual) | Interventional | 2013-07-31 | Terminated(stopped due to Inability to recruit additional subjects.) |
| Camillian Saint Mary's Hospital Luodong [NCT05348148] | | 450 participants (Anticipated) | Interventional | 2020-06-16 | Recruiting |
| [NCT00236106] | Phase 4 | 20 participants | Interventional | 2005-02-28 | Completed |
| A Comparison Between Local Anesthetics and Topical Cortikosteroids That is Applied to the Area of Cuff of Tracheal Intubation Tube in Pediatric Patients [NCT04085744] | | 91 participants (Actual) | Interventional | 2019-11-01 | Completed |
| A Randomized, Single Dose, 3-Period Crossover Study to Evaluate the Dosage Form Proportionality, Dose Proportionality and Pharmacokinetics of Mometasone Furoate and Formoterol Fumarate From Three Combination MDI Formulations [NCT00418509] | Phase 1 | 24 participants | Interventional | 2006-11-30 | Completed |
| Onset and Duration of Action of Mometasone Inhalation Powder as Measured by Oscillometry Versus Spirometry [NCT01635088] | Phase 4 | 21 participants (Actual) | Interventional | 2011-06-30 | Completed |
| Does the Response to a Nasal Decongestant Test Predict the Outcome to Treatment of Seasonal Allergic Rhinitis With Nasonex? [NCT00618332] | | 40 participants (Actual) | Interventional | 2008-04-30 | Completed |
| MULTICENTER, RANDOMIZED, DOUBLE BLIND, CONTROLLED, CLINICAL STUDY TO DEMONSTRATE THE THERAPEUTIC CLINICAL EQUIVALENCE OF TWO MOMETASONE NASAL SPRAYS IN THE RELIEF OF THE SIGNS AND SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS. [NCT01702103] | Phase 3 | 360 participants (Anticipated) | Interventional | 2012-10-31 | Not yet recruiting |
| A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps - The BiRCh Study [NCT06013241] | Phase 2 | 270 participants (Anticipated) | Interventional | 2023-10-30 | Recruiting |
| The PROGRESS Study: Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implants Following Surgical Opening of the Frontal Sinus for Chronic Sinusitis: A Randomized Blinded Controlled Study [NCT02266810] | Phase 3 | 160 participants (Actual) | Interventional | 2014-09-30 | Completed |
| An Exploratory, Multi-centre, Double-blind, Placebocontrolled Crossover Study, to Investigate the Bronchodilatory Efficacy of a Single Dose of Indacaterol in Fixed Combination With Mometasone Furoate Delivered Via a MDDPI (Twisthaler®) in Adult Patients W [NCT00556673] | Phase 2 | 31 participants (Actual) | Interventional | 2007-10-31 | Completed |
| A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant Used in Post-Sinus Surgery Patients With Recurrent Sinus Obstruction [NCT01732536] | Phase 2/Phase 3 | 100 participants (Actual) | Interventional | 2013-01-31 | Completed |
| Efficacy and Safety of Concurrent Administration of Mometasone Furoate Nasal Spray (MFNS) and Oxymetazoline Nasal Spray Administered Once Daily (QD) vs. Oxymetazoline Twice Daily (BID), Mometasone Furoate QD, and Placebo in the Treatment of Subjects With [NCT00552110] | Phase 2 | 707 participants (Actual) | Interventional | 2007-07-31 | Completed |
| A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Sublingual Immunotherapy With SCH 697243 (Phleum Pratense) in Children 5 to <18 Years of Age With a History of Grass Pollen Induced Rhinoconjunctivi [NCT00550550] | Phase 3 | 345 participants (Actual) | Interventional | 2007-11-30 | Completed |
| A Double-blind Placebo-controlled, Randomized, Parallel-group, Multicenter Clinical Trial to Evaluate Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy SNORE Study [NCT00552032] | Phase 3 | 132 participants (Actual) | Interventional | 2007-08-01 | Completed |
| Replication of the P04334 Asthma Trial in Healthcare Claims Data [NCT04892758] | | 10,288 participants (Actual) | Observational | 2020-10-29 | Completed |
| Role of Lung Function, Airway Inflammation and Bronchial Hyper Reactivity for Exercise Capacity in Well-trained Individuals [NCT06077019] | | 60 participants (Anticipated) | Interventional | 2023-10-05 | Recruiting |
| A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation [NCT02880514] | | 50 participants (Actual) | Interventional | 2016-08-31 | Completed |
| A 2-Week Double-Blind, Placebo-Controlled, Parallel Group Study Comparing the Anti-Inflammatory Effects of Low, Medium, and High Dose Mometasone Furoate/Formoterol Fumarate MDI Formulation and Medium Dose Mometasone Furoate DPI and MDI Formulations in Adu [NCT00635882] | Phase 2 | 93 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Assessment of the Effectiveness of Regular Use of Intranasal Steroids in Alleviating Nasal Symptoms in Allergic Rhinitis When Used Alone or in Combination With Oral Antihistamine [NCT00834119] | Phase 4 | 72 participants (Actual) | Interventional | 2003-09-01 | Completed |
| A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in [NCT02631551] | Phase 3 | 1,180 participants (Actual) | Interventional | 2016-03-31 | Completed |
| Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence [NCT02045875] | Phase 4 | 50 participants (Actual) | Interventional | 2014-03-04 | Completed |
| A Double-blind, Randomized, Parallel-group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Two Different Strengths and Regimens of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monoth [NCT02318303] | Phase 2 | 1,111 participants (Actual) | Interventional | 2014-12-31 | Completed |
| Role of Short Term Systemic Corticosteroid Therapy in the Management of Chronic Rhinosinusitis Without Nasal Polyps [NCT01676415] | Phase 4 | 9 participants (Actual) | Interventional | 2012-08-31 | Terminated(stopped due to participants are no longer receiving intervention due to clinical logistics) |
| An Open-Label Study to Assess the Safety and Tolerability of Zenhale® (a Fixed-Dose Combination of Mometasone Furoate/Formoterol Fumarate Delivered by Metered Dose Inhaler) in 40 Subjects With Persistent Asthma (Protocol No. 206-00 [P08212]) [NCT01566149] | Phase 3 | 49 participants (Actual) | Interventional | 2012-03-31 | Completed |
| A Phase 2A, Single-Center, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy of an Anti-Inflammatory Agent in Patients With Sinusitis [NCT02874144] | Phase 2 | 43 participants (Actual) | Interventional | 2016-06-20 | Completed |
| The Role of Nonspecific Immune Response of the Airway Mucosa in Children With Chronic Rhinosinusitis and Asthma [NCT03011632] | Phase 4 | 150 participants (Actual) | Interventional | 2017-01-31 | Completed |
| Steroids In Eosinophil Negative Asthma [NCT02066298] | Phase 3 | 295 participants (Actual) | Interventional | 2014-07-31 | Completed |
| The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa Of Allergic Rhinitis Patients [NCT05919316] | | 40 participants (Anticipated) | Interventional | 2023-07-04 | Not yet recruiting |
| A Randomized, Double-blind, Double-dummy, 4-week Treatment, Parallel-group Study to Evaluate the Efficacy and Safety of Two Doses of Mometasone Furoate Delivered Via Concept1 or Twisthaler® in Adult and Adolescent Patients With Persistent Asthma [NCT01555151] | Phase 2 | 739 participants (Actual) | Interventional | 2012-07-31 | Completed |
| Evaluation of Mechanism(s)Limiting Expiratory Airflow in Chronic, Stable Asthmatics Who Are Non-smokers [NCT00576069] | | 60 participants (Anticipated) | Observational | 2007-10-25 | Recruiting |
| A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent Asthma (Phase 2; Protocol No. P04223AM3) [NCT01502371] | Phase 2 | 583 participants (Actual) | Interventional | 2012-01-25 | Completed |
| Effect of Inhaled Mometasone/Formoterol Versus Inhaled Fluticasone/Salmeterol on Peripheral Airway Function in Asthma Patients [NCT02415179] | | 52 participants (Actual) | Interventional | 2015-05-31 | Completed |
| Anti-IL4/IL13 Therapy With Dupilumab for Prevention of Refractory Chronic Rhinosinusitis After Endoscopic Sinus Surgery for CRSwNP [NCT04596189] | Phase 4 | 36 participants (Anticipated) | Interventional | 2021-05-25 | Recruiting |
| Inhaled Mometasone to Promote Reduction in Vasoocclusive Events [NCT02061202] | Phase 2 | 54 participants (Actual) | Interventional | 2014-03-31 | Completed |
| Elocon vs Fluticasone in Localized Psoriasis [NCT00763529] | Phase 4 | 245 participants (Actual) | Interventional | 2003-01-01 | Completed |
| The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis [NCT05912192] | | 163 participants (Actual) | Interventional | 2022-02-24 | Completed |
| Randomized Controled Double-blinded Study Comparing Mometasone Nasal Spray to Budesonide Irrigations in Patients With Chronic Rhinosinusitis With Nasal Polyposis [NCT03323866] | Phase 3 | 36 participants (Actual) | Interventional | 2017-05-01 | Terminated(stopped due to Difficulty with recruitment) |
| Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma [NCT03141424] | Phase 4 | 110 participants (Anticipated) | Interventional | 2022-06-01 | Recruiting |
| A Multicenter, Randomized, Double-blind, Placebo-controlled, 12-week Treatment, Parallel-group Study to Assess the Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate (75 and 150 µg o.d.) in Patients With Persistent Asthma [NCT01609478] | Phase 2 | 335 participants (Actual) | Interventional | 2012-08-31 | Completed |
| A Double-Blind Placebo-Controlled, Randomized, Parallel-Group, Single-Site Study Of Mometasone Furoate Nasal Spray (MFNS) In Subjects With Mild-Moderate Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) Associated With Perennial Allergic Rhinitis (PAR) Us [NCT00491374] | Phase 4 | 0 participants (Actual) | Interventional | 2006-09-30 | Terminated(stopped due to Very poor enrollment) |
| A Randomized Two Period Two-Way Crossover Study To Evaluate Patient Preference, Satisfaction And Efficacy Of A Nasal Aerosol Versus An Aqueous Nasal Spray Used For The Treatment Of Allergic Rhinitis [NCT01401465] | Phase 3 | 327 participants (Actual) | Interventional | 2011-07-31 | Completed |
| A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis [NCT01920893] | Phase 2 | 60 participants (Actual) | Interventional | 2013-08-31 | Completed |
| A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis W [NCT01700192] | Phase 3 | 1,482 participants (Actual) | Interventional | 2013-01-31 | Completed |
| Efficacy and Safety of 200 mcg QD or 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) vs Amoxicillin vs Placebo as Primary Treatment of Subjects With Acute Rhinosinusitis [NCT00751075] | Phase 3 | 981 participants (Actual) | Interventional | 2003-12-01 | Completed |
| A Multi-center, Randomized, Double-blind, Placebo-controlled Study on Efficacy and Safety of Mometasone Furoate Nasal Spray (MFNS) in the Post Surgical Treatment of Nasal Polyposis [NCT00731185] | Phase 3 | 162 participants (Actual) | Interventional | 2003-09-01 | Completed |
| Assessment of Efficacy and Safety of Sodium Valproate -Loaded Nanospanlastics in Patients With Patchy Alopecia Areata in Comparison to Conventional Therapy With Topical Steroids: a Randomized Controlled Study, With Clinical, Dermoscopic and Molecular Ases [NCT05017454] | Early Phase 1 | 67 participants (Actual) | Interventional | 2021-05-01 | Completed |
| National, Multicenter, Randomized, Simple-blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Magnólia Nasal Gel in the Treatment of Allergic Rhinitis in Participants With Age Greater Than or Equal to 12 Years. [NCT04670653] | Phase 3 | 0 participants (Actual) | Interventional | 2022-08-01 | Withdrawn(stopped due to Sponsor decision) |
| Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Head and Neck Squamous Cell Carcinomas' Patients Receiving Radiation Therapy [NCT02495064] | Phase 4 | 160 participants (Anticipated) | Interventional | 2015-01-31 | Recruiting |
| Double-Blind, Randomized, Placebo-Controlled Trial of AKST4290 for Adjunctive Treatment of Mild to Moderate Bullous Pemphigoid [NCT04499235] | Phase 2 | 6 participants (Actual) | Interventional | 2020-01-30 | Terminated(stopped due to The study was prematurely terminated by the Sponsor due to operational challenges stemming from the coronavirus disease 2019 (COVID-19) pandemic, treatment limitations, rarity of the disease, and drug supply considerations.) |
| [NCT01673659] | Phase 3 | 1,220 participants (Actual) | Interventional | 2012-08-31 | Completed |
| A Randomized Controlled Trial of Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy [NCT01671852] | Phase 3 | 0 participants (Actual) | Interventional | 2012-05-31 | Withdrawn(stopped due to Could not obtain funding.) |
| A Phase III, Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-3641, a Ragweed (Ambrosia Artemisiifolia) Sublingual Immunotherapy Tablet, in Children With a History of Ragweed-Induced Rhinoconjunctivitis With or Without [NCT02478398] | Phase 3 | 1,025 participants (Actual) | Interventional | 2015-07-20 | Completed |
| Xenon MRI Probing vEntilation Response to Triple Therapy (QVM149) [NCT04206761] | Phase 3 | 0 participants (Actual) | Interventional | 2021-12-01 | Withdrawn(stopped due to issues related to Covid-19 restrictions/shutdowns) |
| Establishment of Precise Diagnosis and Treatment System for Refractory Chronic Rhinosinusitis [NCT05390255] | Phase 3 | 87 participants (Anticipated) | Interventional | 2022-05-25 | Recruiting |
| [NCT01850823] | Phase 3 | 880 participants (Actual) | Interventional | 2013-02-28 | Completed |
| A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Concomitant Mometasone Furoate and Levocabastine HCl in Perennial Allergic Rhinitis Patients [NCT02498509] | Phase 3 | 459 participants (Anticipated) | Interventional | 2015-05-31 | Completed |
| Onset of Action of Mometasone Furoate Nasal Spray vs. Placebo in Induced Allergic Rhinitis [NCT00783237] | Phase 4 | 340 participants (Actual) | Interventional | 2003-12-01 | Completed |
| A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Sinus Obstruction [NCT02291549] | Phase 3 | 300 participants (Actual) | Interventional | 2014-12-31 | Completed |
| The EXCEED Study: A Clinical Evaluation of the Drug-Eluting Propel Nova Sinus Implant When Placed in Peripheral Sinus Ostia to Maintain Patency [NCT02228720] | | 15 participants (Actual) | Interventional | 2014-06-30 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT00070707 (21) [back to overview] | Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma |
| NCT00070707 (21) [back to overview] | Change From Baseline in AM and PM Chest Tightness Symptom Score |
| NCT00070707 (21) [back to overview] | Change From Baseline in AM and PM Cough Symptom Score |
| NCT00070707 (21) [back to overview] | Change From Baseline in AM and PM Difficulty Breathing Symptom Score |
| NCT00070707 (21) [back to overview] | Change From Baseline in AM and PM Nasal Congestion Symptom Score |
| NCT00070707 (21) [back to overview] | Change From Baseline in AM and PM Nasal Itching Symptom Score |
| NCT00070707 (21) [back to overview] | Change From Baseline in AM and PM Nasal Sneezing Symptom Score |
| NCT00070707 (21) [back to overview] | Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR) |
| NCT00070707 (21) [back to overview] | Change From Baseline in AM and PM Rhinorrhea Symptom Score |
| NCT00070707 (21) [back to overview] | Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS) |
| NCT00070707 (21) [back to overview] | Change From Baseline in AM and PM Wheeze Symptom Score |
| NCT00070707 (21) [back to overview] | Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%) |
| NCT00070707 (21) [back to overview] | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) |
| NCT00070707 (21) [back to overview] | Change From Baseline in Forced Vital Capacity (FVC) |
| NCT00070707 (21) [back to overview] | Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS) |
| NCT00070707 (21) [back to overview] | Change From Baseline in Pulmonary Auscultation/Wheezing Assessment |
| NCT00070707 (21) [back to overview] | Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used |
| NCT00070707 (21) [back to overview] | Change From Baseline in Weekly Average Interference With Daily Activities |
| NCT00070707 (21) [back to overview] | Change From Baseline in Weekly Average Interference With Sleep |
| NCT00070707 (21) [back to overview] | Therapeutic Response to SAR Nasal Symptoms |
| NCT00070707 (21) [back to overview] | Therapeutic Response to Asthma Symptoms |
| NCT00358527 (2) [back to overview] | Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. |
| NCT00358527 (2) [back to overview] | Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. |
| NCT00359216 (1) [back to overview] | Apnea-Hypopnea Index |
| NCT00361439 (4) [back to overview] | Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks |
| NCT00361439 (4) [back to overview] | Histological Findings |
| NCT00361439 (4) [back to overview] | Change From Baseline in Total Nasal Symptom Score at 2 Weeks |
| NCT00361439 (4) [back to overview] | Change From Baseline in Percentage of Eosinophils at 2 Weeks |
| NCT00378378 (2) [back to overview] | Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine |
| NCT00378378 (2) [back to overview] | Change From Baseline 24-hour Urinary Free Cortisol Level |
| NCT00379288 (1) [back to overview] | The Number of All Randomized Subjects Reporting Adverse Events (AEs). |
| NCT00381485 (4) [back to overview] | Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma That Require Use of Short-Acting Beta Agonists (SABA) |
| NCT00381485 (4) [back to overview] | Change From Baseline to Week 12 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score |
| NCT00381485 (4) [back to overview] | Change From Baseline to Week 12 in Asthma Control Questionnaire (ACQ) Total Score |
| NCT00381485 (4) [back to overview] | Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) |
| NCT00383240 (6) [back to overview] | Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score |
| NCT00383240 (6) [back to overview] | Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score |
| NCT00383240 (6) [back to overview] | Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF |
| NCT00383240 (6) [back to overview] | Number of Participants With at Least One Severe Asthma Exacerbation |
| NCT00383240 (6) [back to overview] | Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F |
| NCT00383240 (6) [back to overview] | Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA) |
| NCT00383435 (6) [back to overview] | Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) |
| NCT00383435 (6) [back to overview] | Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 |
| NCT00383435 (6) [back to overview] | Number of Participants With Mild, Moderate, or Severe COPD Exacerbations |
| NCT00383435 (6) [back to overview] | Number of Participants With Partly Stable COPD |
| NCT00383435 (6) [back to overview] | Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms) |
| NCT00383435 (6) [back to overview] | Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score |
| NCT00383552 (8) [back to overview] | AUC(0-12 Hour) of the Change From Baseline to Week 12 in FEV1 for Each Body Mass Index (BMI) Subgroup |
| NCT00383552 (8) [back to overview] | Change From Baseline in AM FEV1 Pre-dose Assessment, or Trough FEV1, at Week 12 |
| NCT00383552 (8) [back to overview] | Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta Agonists (SABA) |
| NCT00383552 (8) [back to overview] | Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) |
| NCT00383552 (8) [back to overview] | Median Time-to-first Severe Asthma Exacerbation Over the 26-week Treatment Period |
| NCT00383552 (8) [back to overview] | Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standarized Activities (AQLQ[S]) Total Score |
| NCT00383552 (8) [back to overview] | Number of Participants With at Least One Severe Asthma Exacerbation at Week 26 |
| NCT00383552 (8) [back to overview] | Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Total Score |
| NCT00383721 (6) [back to overview] | Number of Participants With Partly Stable COPD |
| NCT00383721 (6) [back to overview] | Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms) |
| NCT00383721 (6) [back to overview] | Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score |
| NCT00383721 (6) [back to overview] | Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) |
| NCT00383721 (6) [back to overview] | Number of Participants With Mild, Moderate, or Severe COPD Exacerbations |
| NCT00383721 (6) [back to overview] | Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 |
| NCT00394355 (4) [back to overview] | Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point |
| NCT00394355 (4) [back to overview] | Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second). |
| NCT00394355 (4) [back to overview] | Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point |
| NCT00394355 (4) [back to overview] | Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point |
| NCT00424008 (4) [back to overview] | Onset-of-action Based on Change From Baseline FEV1 at the 5 Min Pulmonary Function Test (PFT) Assessment on Day 1 |
| NCT00424008 (4) [back to overview] | Change From Baseline in Asthma Control Questionnaire (ACQ) Total Score at Week 12 Endpoint |
| NCT00424008 (4) [back to overview] | The Proportion of Symptom-free Days and Nights (Combined) Over the 12-week Treatment Period. |
| NCT00424008 (4) [back to overview] | The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) |
| NCT00438659 (8) [back to overview] | Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16). |
| NCT00438659 (8) [back to overview] | Adverse Events Assessed Clinically by NCI CTCAE v3.0 |
| NCT00438659 (8) [back to overview] | Adverse Events Reported by the Patient in the Symptom Experience Diary (SED). |
| NCT00438659 (8) [back to overview] | Incidence of Severe ( Grade >=3) Radiation Dermatitis |
| NCT00438659 (8) [back to overview] | QOL Domains as Measured by LASA |
| NCT00438659 (8) [back to overview] | Skin Toxicity as Measured by the Skin Toxicity Assessment Tool |
| NCT00438659 (8) [back to overview] | Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA) |
| NCT00438659 (8) [back to overview] | Mean Maximum Grade of Radiation Dermatitis by Treatment Arm. |
| NCT00442117 (4) [back to overview] | Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12. |
| NCT00442117 (4) [back to overview] | Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12. |
| NCT00442117 (4) [back to overview] | Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12. |
| NCT00442117 (4) [back to overview] | Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12. |
| NCT00453063 (5) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) |
| NCT00453063 (5) [back to overview] | Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 |
| NCT00453063 (5) [back to overview] | Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 |
| NCT00453063 (5) [back to overview] | Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 |
| NCT00453063 (5) [back to overview] | Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 |
| NCT00468312 (5) [back to overview] | Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 |
| NCT00468312 (5) [back to overview] | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) |
| NCT00468312 (5) [back to overview] | Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 |
| NCT00468312 (5) [back to overview] | Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 |
| NCT00468312 (5) [back to overview] | Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 |
| NCT00491374 (1) [back to overview] | The Change From Baseline in the Number of Apnea-hypopnea Episodes Per Hour (Apnea-hypopnea Index (AHI) |
| NCT00491504 (1) [back to overview] | Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1 |
| NCT00521599 (1) [back to overview] | Change From Baseline in the Average AM Peak Expiratory Flow (PEF) Over the 7 Days of Week 8. |
| NCT00550550 (4) [back to overview] | Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS) |
| NCT00550550 (4) [back to overview] | Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS |
| NCT00550550 (4) [back to overview] | Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS |
| NCT00550550 (4) [back to overview] | Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS |
| NCT00552032 (20) [back to overview] | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done |
| NCT00552032 (20) [back to overview] | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance |
| NCT00552032 (20) [back to overview] | Number of Participants With Otoscopic Results of: Normal or Abnormal |
| NCT00552032 (20) [back to overview] | Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa |
| NCT00552032 (20) [back to overview] | Total Severity Symptom Scores: Morning and Evening (AM & PM) |
| NCT00552032 (20) [back to overview] | Total Frequency Symptom Scores: AM & PM |
| NCT00552032 (20) [back to overview] | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance |
| NCT00552032 (20) [back to overview] | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa |
| NCT00552032 (20) [back to overview] | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa |
| NCT00552032 (20) [back to overview] | Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12) |
| NCT00552032 (20) [back to overview] | Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa |
| NCT00552032 (20) [back to overview] | Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4) |
| NCT00552032 (20) [back to overview] | Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score |
| NCT00552032 (20) [back to overview] | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic |
| NCT00552032 (20) [back to overview] | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation |
| NCT00552032 (20) [back to overview] | Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction |
| NCT00552032 (20) [back to overview] | Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done |
| NCT00552032 (20) [back to overview] | Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe |
| NCT00552032 (20) [back to overview] | Change From Baseline in Adenoid/Choana (A/C) Index Grade |
| NCT00552032 (20) [back to overview] | Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7) |
| NCT00552110 (2) [back to overview] | Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15 |
| NCT00552110 (2) [back to overview] | Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score |
| NCT00556673 (15) [back to overview] | Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) |
| NCT00556673 (15) [back to overview] | Change From Period Baseline in Trough FEV1/FVC Ratio |
| NCT00556673 (15) [back to overview] | Change From Period Baseline in Trough Forced Vital Capacity (FVC) |
| NCT00556673 (15) [back to overview] | Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) |
| NCT00556673 (15) [back to overview] | Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) |
| NCT00556673 (15) [back to overview] | Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol |
| NCT00556673 (15) [back to overview] | Maximum (Peak) Plasma Concentration (Cmax) of Mometasone Furoate |
| NCT00556673 (15) [back to overview] | Time to Reach Peak or Maximum Concentration Following Drug Administration for Mometasone Furoate |
| NCT00556673 (15) [back to overview] | Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate |
| NCT00556673 (15) [back to overview] | Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol |
| NCT00556673 (15) [back to overview] | Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate |
| NCT00556673 (15) [back to overview] | Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) |
| NCT00556673 (15) [back to overview] | Change From Period Baseline in Peak FEV1/FVC Ratio |
| NCT00556673 (15) [back to overview] | Change From Period Baseline in Peak Forced Vital Capacity (FVC) |
| NCT00556673 (15) [back to overview] | Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol |
| NCT00557440 (5) [back to overview] | Forced Expiratory Volume in 1 Second (FEV1) Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours Post-dose |
| NCT00557440 (5) [back to overview] | Forced Vital Capacity (FVC) at Single Time Points |
| NCT00557440 (5) [back to overview] | Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points |
| NCT00557440 (5) [back to overview] | Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) |
| NCT00557440 (5) [back to overview] | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) |
| NCT00562159 (4) [back to overview] | Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire With Standardized Activities (RQLQ(S)) Total Score Over the Entire GPS |
| NCT00562159 (4) [back to overview] | Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS) |
| NCT00562159 (4) [back to overview] | Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS |
| NCT00562159 (4) [back to overview] | Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS |
| NCT00599027 (1) [back to overview] | The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment. |
| NCT00604500 (4) [back to overview] | End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population) |
| NCT00604500 (4) [back to overview] | Overall Quartile Discrepancy Rate |
| NCT00604500 (4) [back to overview] | Overall Discrepancy Size |
| NCT00604500 (4) [back to overview] | Overall Discrepancy Rate |
| NCT00605306 (4) [back to overview] | Levels of Plasma Glucose Over Time |
| NCT00605306 (4) [back to overview] | Levels of Serum Cortisol Over Time |
| NCT00605306 (4) [back to overview] | Levels of Serum Potassium Over Time |
| NCT00605306 (4) [back to overview] | Participants With Adverse Events |
| NCT00618332 (9) [back to overview] | Changes in RQLQ: Non-Nasal/Eye |
| NCT00618332 (9) [back to overview] | Changes in RQLQ: Eye |
| NCT00618332 (9) [back to overview] | Changes in RQLQ: Emotional |
| NCT00618332 (9) [back to overview] | Changes in RQLQ: Activity |
| NCT00618332 (9) [back to overview] | Changes in RQLQ: Nasal |
| NCT00618332 (9) [back to overview] | Global Assessment |
| NCT00618332 (9) [back to overview] | Changes in RQLQ: Sleep |
| NCT00618332 (9) [back to overview] | Changes in RQLQ: Practical |
| NCT00618332 (9) [back to overview] | Changes in RQLQ: Overall |
| NCT00635882 (9) [back to overview] | Mean Change From Baseline to Day 15 of Mannitol Challenge |
| NCT00635882 (9) [back to overview] | Change From Baseline in PM Total Asthma Symptom Score at Days 1-15 |
| NCT00635882 (9) [back to overview] | Change From Baseline in PM PEF at Days 1-15 |
| NCT00635882 (9) [back to overview] | Change From Baseline in AM Total Asthma Symptom Score at Days 2-15 |
| NCT00635882 (9) [back to overview] | Change From Baseline in AM Peak Expiratory Flow (PEF) at Days 2-15 |
| NCT00635882 (9) [back to overview] | Mean Percent Change From Baseline to Day 14 in Sputum Eosinophil Count (Percentage) |
| NCT00635882 (9) [back to overview] | Mean Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb) |
| NCT00635882 (9) [back to overview] | Mean Percent Change From Baseline to Day 7 in eNO Ppb |
| NCT00635882 (9) [back to overview] | Baseline Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb) |
| NCT00666679 (8) [back to overview] | Percentage of Days With Asthma Control |
| NCT00666679 (8) [back to overview] | Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) |
| NCT00666679 (8) [back to overview] | Change From Baseline in Nighttime Asthma Symptom Score |
| NCT00666679 (8) [back to overview] | Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) in Patients Who Met Lung Function Eligibility Criteria Specifically at the Randomization Visit. |
| NCT00666679 (8) [back to overview] | Change From Baseline in Total Daily β-agonist Use |
| NCT00666679 (8) [back to overview] | Change From Baseline in Daytime Asthma Symptom Score |
| NCT00666679 (8) [back to overview] | Change From Baseline in Total Peripheral Blood Eosinophils |
| NCT00666679 (8) [back to overview] | Percentage of Days With Asthma Exacerbations |
| NCT00687531 (4) [back to overview] | Number of Items in the Asthma Quality of Life (QOL) Questionnaire and the General QOL Questionnaire That Had a Significant (Positive) Change From Baseline to Endpoint |
| NCT00687531 (4) [back to overview] | Number of Participants Who Adhered to Treatment |
| NCT00687531 (4) [back to overview] | Forced Expiratory Volume in 1 Second (FEV1) |
| NCT00687531 (4) [back to overview] | Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR) |
| NCT00720382 (3) [back to overview] | Change From Baseline on Direct Visual Nasal Exams to 12 Months |
| NCT00720382 (3) [back to overview] | Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older |
| NCT00720382 (3) [back to overview] | Change From Baseline on Direct Visual Nasal Exams to 12 Months |
| NCT00728416 (2) [back to overview] | Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days |
| NCT00728416 (2) [back to overview] | Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days |
| NCT00732381 (2) [back to overview] | The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days |
| NCT00732381 (2) [back to overview] | The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days |
| NCT00733005 (2) [back to overview] | The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days |
| NCT00733005 (2) [back to overview] | The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days. |
| NCT00746330 (6) [back to overview] | Plasma Formoterol Concentrations (Pmol/L) Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI) |
| NCT00746330 (6) [back to overview] | The Standardized Forced Expiratory Volume in 1 Second (FEV1) Using Area Under the Curve (AUC) From 0 to 12 Hours (0-12h) Post-dose by Treatment |
| NCT00746330 (6) [back to overview] | Serial FEV1 Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect |
| NCT00746330 (6) [back to overview] | Serial Forced Vital Capacity (FVC) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect |
| NCT00746330 (6) [back to overview] | Serial Peak Expiratory Flow Rate (PEF) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect |
| NCT00746330 (6) [back to overview] | Urinary Excretion of Formoterol Following a Single Dose of Formoterol Fumarate Alone and in Combination With Mometasone Furoate Via the pMDI and Formoterol Fumarate Via the Dry Powder Inhaler (DPI) |
| NCT00783224 (1) [back to overview] | Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks |
| NCT00941798 (12) [back to overview] | Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit |
| NCT00941798 (12) [back to overview] | Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit |
| NCT00941798 (12) [back to overview] | Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death. |
| NCT00941798 (12) [back to overview] | Number of Patients With at Least One Asthma Worsening Post-baseline |
| NCT00941798 (12) [back to overview] | Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids |
| NCT00941798 (12) [back to overview] | Time to First Serious Asthma Exacerbation |
| NCT00941798 (12) [back to overview] | Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime |
| NCT00941798 (12) [back to overview] | Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit |
| NCT00941798 (12) [back to overview] | Change From Baseline in Forced Vital Capacity (FVC) at Final Visit |
| NCT00941798 (12) [back to overview] | Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime |
| NCT00941798 (12) [back to overview] | Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period |
| NCT00941798 (12) [back to overview] | Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime |
| NCT01038427 (4) [back to overview] | Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population) |
| NCT01038427 (4) [back to overview] | Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Equivalence: Per-Protocol Population) |
| NCT01038427 (4) [back to overview] | Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Superiority: Intent-to-Treat Population) |
| NCT01038427 (4) [back to overview] | Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Superiority: Intent-to-Treat Population) |
| NCT01061333 (8) [back to overview] | Allergen-induced Concentrations of Sputum LTC4 |
| NCT01061333 (8) [back to overview] | Allergen-induced Concentrations of Sputum LTD4 |
| NCT01061333 (8) [back to overview] | Allergen-induced Concentrations of Sputum LTE4 |
| NCT01061333 (8) [back to overview] | Change in Forced Expiratory Volume in 1 Second (FEV1) |
| NCT01061333 (8) [back to overview] | Change in Plasma 9P at 20 Minutes |
| NCT01061333 (8) [back to overview] | Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes |
| NCT01061333 (8) [back to overview] | Allergen-induced Changes in Urinary 9P |
| NCT01061333 (8) [back to overview] | Allergen-induced Changes in Urinary Leukotriene (LT) E4 |
| NCT01098071 (8) [back to overview] | Degree of Posterior Choana Obstruction at Baseline and Week 12 |
| NCT01098071 (8) [back to overview] | Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy |
| NCT01098071 (8) [back to overview] | Severity of Eye Symptoms at Baseline and Week 12 |
| NCT01098071 (8) [back to overview] | Severity of Sneezing at Baseline and Week 12 |
| NCT01098071 (8) [back to overview] | Severity of Rhinorrhea at Baseline and Week 12 |
| NCT01098071 (8) [back to overview] | Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score |
| NCT01098071 (8) [back to overview] | Severity of Nasal Itching at Baseline and Week 12 |
| NCT01098071 (8) [back to overview] | Severity of Nasal Congestion at Baseline and Week 12 |
| NCT01118312 (2) [back to overview] | Childhood Asthma Control Test |
| NCT01118312 (2) [back to overview] | Asthma Control Test (ACT) |
| NCT01135134 (2) [back to overview] | Change From Baseline in the Total Nasal Symptom Score at 1 Week |
| NCT01135134 (2) [back to overview] | Change From Baseline in the Total Nasal Symptom Score at 2 Weeks |
| NCT01165424 (2) [back to overview] | Change From Baseline in the Total Nasal Symptom Score |
| NCT01165424 (2) [back to overview] | Number of Participants With Adverse Events and Adverse Drug Reactions |
| NCT01210170 (2) [back to overview] | Albuterol Induced Percent Change in Qaw |
| NCT01210170 (2) [back to overview] | Albuterol-induced Change in FEV1 |
| NCT01258803 (8) [back to overview] | Area Under the Curve From 0-12 Hours (AUC[0-12h]) of the Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) After a Single Dose of MF/F MDI With Spacer Compared to Placebo MDI Combined With or Without Spacer |
| NCT01258803 (8) [back to overview] | AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of F DPI Compared to Placebo MDI Combined With or Without Spacer |
| NCT01258803 (8) [back to overview] | AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F With Spacer Compared to F DPI |
| NCT01258803 (8) [back to overview] | AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F Without Spacer Compared to F DPI |
| NCT01258803 (8) [back to overview] | AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose MF/F MDI Without Spacer Compared to Placebo MDI Combined With or Without Spacer |
| NCT01258803 (8) [back to overview] | AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer Compared to MF/F MDI Without Spacer |
| NCT01258803 (8) [back to overview] | Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose |
| NCT01258803 (8) [back to overview] | Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose |
| NCT01287364 (6) [back to overview] | Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High) |
| NCT01287364 (6) [back to overview] | Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales |
| NCT01287364 (6) [back to overview] | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) |
| NCT01287364 (6) [back to overview] | Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES) |
| NCT01287364 (6) [back to overview] | Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics |
| NCT01287364 (6) [back to overview] | Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change) |
| NCT01371786 (5) [back to overview] | Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose |
| NCT01371786 (5) [back to overview] | Initial Deposition of Radioactivity on Nasal Wipes as a Percent of Delivered Dose |
| NCT01371786 (5) [back to overview] | Deposition of Radioactivity Within the Nasal Cavity Over 10 Minutes as a Percent of Delivered Dose |
| NCT01371786 (5) [back to overview] | Deposition of Radioactivity Within on Nasal Wipes Over 10 Minutes as a Percent of Delivered Dose |
| NCT01371786 (5) [back to overview] | Initial Deposition of Radioactivity Within the Nasopharynx as a Percent of Delivered Dose |
| NCT01386125 (2) [back to overview] | Change From Baseline in Congestion/Obstruction Score |
| NCT01386125 (2) [back to overview] | Change From Baseline in Total Polyp Size Score |
| NCT01401465 (31) [back to overview] | The Percentage of Subjects Experiencing AEs |
| NCT01401465 (31) [back to overview] | The Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation |
| NCT01401465 (31) [back to overview] | Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items |
| NCT01401465 (31) [back to overview] | Treatment Outcome Composite Score Assessed at the End of the Study |
| NCT01401465 (31) [back to overview] | Treatment Process Composite Preference Score |
| NCT01401465 (31) [back to overview] | Work/Disability Days: Bed Days |
| NCT01401465 (31) [back to overview] | Work/Disability Days: Missed Work |
| NCT01401465 (31) [back to overview] | Work/Disability Days: Reduced Activity Days |
| NCT01401465 (31) [back to overview] | Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties |
| NCT01401465 (31) [back to overview] | Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation |
| NCT01401465 (31) [back to overview] | Change From Baseline in the Treatment Satisfaction Rating Scale: Interference |
| NCT01401465 (31) [back to overview] | The Change From Baseline in Health-Related Quality of Life: General Symptom Interference Scale |
| NCT01401465 (31) [back to overview] | The Change From Baseline in Health-Related Quality of Life: General Health Perceptions Scale |
| NCT01401465 (31) [back to overview] | Change From Baseline in the Treatment Satisfaction Rating Scale: Burden |
| NCT01401465 (31) [back to overview] | Change From Baseline in the Treatment Functional Impact Composite Score |
| NCT01401465 (31) [back to overview] | Change From Baseline in the Regimen Acceptance Composite Score |
| NCT01401465 (31) [back to overview] | Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period. |
| NCT01401465 (31) [back to overview] | Change From Baseline in Regimen Attributes Composite Score |
| NCT01401465 (31) [back to overview] | The Change From Baseline in Health-Related Quality of Life: Allergic-Rhinitis Specific Symptom Interference Scale |
| NCT01401465 (31) [back to overview] | Change From Baseline in the Treatment Satisfaction Rating Scale: Sensory Impact |
| NCT01401465 (31) [back to overview] | Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation |
| NCT01401465 (31) [back to overview] | Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Management |
| NCT01401465 (31) [back to overview] | The Change From Baseline in Overall Quality of Life Composite Score |
| NCT01401465 (31) [back to overview] | The Change From Baseline in the Treatment Satisfaction Rating Scale: Perceived Relief |
| NCT01401465 (31) [back to overview] | The Number of Subjects Experiencing AEs |
| NCT01401465 (31) [back to overview] | The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation |
| NCT01401465 (31) [back to overview] | The Change From Baseline in Health-Related Quality of Life: Symptoms and Side-Effects Distress Scale |
| NCT01401465 (31) [back to overview] | Change From Baseline in the Treatment Satisfaction Rating Scale: Hassle |
| NCT01401465 (31) [back to overview] | The Change From Baseline in Health-Related Quality of Life: Work Well Being Questionnaire Scale |
| NCT01401465 (31) [back to overview] | The Change From Baseline in Health-Related Quality of Life: Perceived Health (Global Analogue Scale) |
| NCT01401465 (31) [back to overview] | The Change From Baseline in Health-Related Quality of Life: Mental and Emotional Health Scale |
| NCT01471340 (3) [back to overview] | Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms |
| NCT01471340 (3) [back to overview] | Number of SAO Components in MF/F Participants vs MF Participants |
| NCT01471340 (3) [back to overview] | Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms |
| NCT01502371 (4) [back to overview] | Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo |
| NCT01502371 (4) [back to overview] | Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD |
| NCT01502371 (4) [back to overview] | Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo |
| NCT01502371 (4) [back to overview] | Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo |
| NCT01555151 (11) [back to overview] | Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment |
| NCT01555151 (11) [back to overview] | Trough Forced Expiratory Volume in 1 Second (FEV1) |
| NCT01555151 (11) [back to overview] | Plasma Cortisol Concentrations |
| NCT01555151 (11) [back to overview] | Fractional Exhaled Nitric Oxide (FeNO) |
| NCT01555151 (11) [back to overview] | Forced Vital Capacity (FVC) at All Time Points |
| NCT01555151 (11) [back to overview] | Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points |
| NCT01555151 (11) [back to overview] | Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment |
| NCT01555151 (11) [back to overview] | Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit |
| NCT01555151 (11) [back to overview] | Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment |
| NCT01555151 (11) [back to overview] | Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment |
| NCT01555151 (11) [back to overview] | Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points |
| NCT01566149 (5) [back to overview] | Number of Participants With At Least One Serious AE |
| NCT01566149 (5) [back to overview] | Number of Participants With At Least One Drug-Related AE |
| NCT01566149 (5) [back to overview] | Number of Participants With At Least One Adverse Event (AE) |
| NCT01566149 (5) [back to overview] | Number of Participants Who Discontinued From the Study Due to an AE |
| NCT01566149 (5) [back to overview] | Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12 |
| NCT01609478 (20) [back to overview] | Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period |
| NCT01609478 (20) [back to overview] | Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment. |
| NCT01609478 (20) [back to overview] | Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points |
| NCT01609478 (20) [back to overview] | Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85) |
| NCT01609478 (20) [back to overview] | The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period |
| NCT01609478 (20) [back to overview] | Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period |
| NCT01609478 (20) [back to overview] | Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85) |
| NCT01609478 (20) [back to overview] | Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment |
| NCT01609478 (20) [back to overview] | Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment |
| NCT01609478 (20) [back to overview] | Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period |
| NCT01609478 (20) [back to overview] | Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 |
| NCT01609478 (20) [back to overview] | Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 |
| NCT01609478 (20) [back to overview] | Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period. |
| NCT01609478 (20) [back to overview] | Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84) |
| NCT01609478 (20) [back to overview] | Plasma Indacaterol Concentrations at Day 1 and Day 14 |
| NCT01609478 (20) [back to overview] | Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84) |
| NCT01609478 (20) [back to overview] | The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period |
| NCT01609478 (20) [back to overview] | The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period |
| NCT01609478 (20) [back to overview] | The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment |
| NCT01609478 (20) [back to overview] | Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period |
| NCT01616160 (2) [back to overview] | Change in Steroid Sensitivity in Vivo Nasal Endoscopy Polyp Scores |
| NCT01616160 (2) [back to overview] | Change in Steroid Sensitivity in Vivo Symptom Scores - Trouble With Sense of Smell |
| NCT01676415 (3) [back to overview] | Medication Side-effect and Compliance Inventory |
| NCT01676415 (3) [back to overview] | Taskforce Symptom Inventory |
| NCT01676415 (3) [back to overview] | SNOT-22 Questionnaire |
| NCT01700192 (7) [back to overview] | Number of Participants Who Experience At Least One Adverse Event (AE) |
| NCT01700192 (7) [back to overview] | Number of Participants Who Discontinue Study Drug Due to an AE |
| NCT01700192 (7) [back to overview] | Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment |
| NCT01700192 (7) [back to overview] | Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment |
| NCT01700192 (7) [back to overview] | Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment |
| NCT01700192 (7) [back to overview] | Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment |
| NCT01700192 (7) [back to overview] | Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment |
| NCT01732536 (6) [back to overview] | Bilateral Polyp Grade |
| NCT01732536 (6) [back to overview] | Bilateral Polyp Grade |
| NCT01732536 (6) [back to overview] | Ethmoid Sinus Obstruction |
| NCT01732536 (6) [back to overview] | Nasal Obstruction Symptom Evaluation (NOSE) Score |
| NCT01732536 (6) [back to overview] | Nasal Obstruction/Congestion Score |
| NCT01732536 (6) [back to overview] | Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS) |
| NCT01850823 (2) [back to overview] | Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14. |
| NCT01850823 (2) [back to overview] | Superiority of Active Treatment Arms Over Placebo |
| NCT01856543 (3) [back to overview] | Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up |
| NCT01856543 (3) [back to overview] | Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment |
| NCT01856543 (3) [back to overview] | Percentage of Participants With Moist Desquamation |
| NCT01894503 (2) [back to overview] | Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ |
| NCT01894503 (2) [back to overview] | Number of Sinuses With Successful Implant Delivery |
| NCT01920893 (11) [back to overview] | Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score |
| NCT01920893 (11) [back to overview] | Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16 |
| NCT01920893 (11) [back to overview] | Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease |
| NCT01920893 (11) [back to overview] | Change From Baseline in Nasal Total Symptoms Score (nTSS) at Week 16 |
| NCT01920893 (11) [back to overview] | Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16 |
| NCT01920893 (11) [back to overview] | Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 |
| NCT01920893 (11) [back to overview] | Time to First Response in NPS: Kaplan-Meier Estimate at Week 16 |
| NCT01920893 (11) [back to overview] | Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16 |
| NCT01920893 (11) [back to overview] | Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16 |
| NCT01920893 (11) [back to overview] | Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16 |
| NCT01920893 (11) [back to overview] | Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma |
| NCT02045875 (3) [back to overview] | Overall Adherence to Dulera 100/5 and 200/5 |
| NCT02045875 (3) [back to overview] | Adherence to Dulera 100/5 and 200/5 |
| NCT02045875 (3) [back to overview] | Asthma Control |
| NCT02061202 (10) [back to overview] | Change in the Numerical Rating Scale (NRS) for Pain |
| NCT02061202 (10) [back to overview] | Number of Participants Who Completed Follow up |
| NCT02061202 (10) [back to overview] | Asthma Control Test |
| NCT02061202 (10) [back to overview] | Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) |
| NCT02061202 (10) [back to overview] | Change in Exhaled Nitric Oxide (eNO) |
| NCT02061202 (10) [back to overview] | Change in FEV1/FVC |
| NCT02061202 (10) [back to overview] | Change in Reticulocytes Count |
| NCT02061202 (10) [back to overview] | Change in Soluble Vascular Cell Adhesion Molecule (sVCAM) Level |
| NCT02061202 (10) [back to overview] | The Medication Adherence Report Scale |
| NCT02061202 (10) [back to overview] | Admissions or Visits to the Hospital |
| NCT02066298 (6) [back to overview] | Peak Expiratory Flow Rate |
| NCT02066298 (6) [back to overview] | Treatment Failure |
| NCT02066298 (6) [back to overview] | Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1. |
| NCT02066298 (6) [back to overview] | Asthma Exacerbations |
| NCT02066298 (6) [back to overview] | Annualized Asthma Control Days |
| NCT02066298 (6) [back to overview] | Forced Expiratory Volume at One Second (FEV1) Percent of Predicted |
| NCT02228720 (5) [back to overview] | Ostial Patency |
| NCT02228720 (5) [back to overview] | Device Placement Success Rate |
| NCT02228720 (5) [back to overview] | Degree of Inflammation |
| NCT02228720 (5) [back to overview] | Adhesion/Scarring Grade 2 & 3 |
| NCT02228720 (5) [back to overview] | Sino-Nasal Outcome Test (SNOT) 22 |
| NCT02266810 (10) [back to overview] | Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort) |
| NCT02266810 (10) [back to overview] | Occlusion/Restenosis (Propel Mini Cohort) |
| NCT02266810 (10) [back to overview] | Need for Surgical Interventions (Propel Nova Cohort) |
| NCT02266810 (10) [back to overview] | Need for Surgical Interventions (Propel Mini Cohort) |
| NCT02266810 (10) [back to overview] | Occlusion/Restenosis (Propel Nova Cohort) |
| NCT02266810 (10) [back to overview] | Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort) |
| NCT02266810 (10) [back to overview] | Need for Post-operative Interventions (Propel Nova Cohort) |
| NCT02266810 (10) [back to overview] | Inflammation (Propel Mini Cohort) |
| NCT02266810 (10) [back to overview] | Need for Post-operative Interventions (Propel Mini Cohort) |
| NCT02266810 (10) [back to overview] | Inflammation (Propel Nova Cohort) |
| NCT02291549 (7) [back to overview] | Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS) |
| NCT02291549 (7) [back to overview] | Nasal Obstruction/Congestion Score |
| NCT02291549 (7) [back to overview] | Bilateral Polyp Grade |
| NCT02291549 (7) [back to overview] | Ethmoid Sinus Obstruction |
| NCT02291549 (7) [back to overview] | Decreased Sense of Smell Score |
| NCT02291549 (7) [back to overview] | Facial Pain/Pressure Score |
| NCT02291549 (7) [back to overview] | Nasal Obstruction/Congestion Score |
| NCT02318303 (1) [back to overview] | Change in rTNSS From Baseline to End of Treatment |
| NCT02478398 (7) [back to overview] | Percentage of Participants Reporting Anaphylaxis and/or Systemic Allergic Reactions |
| NCT02478398 (7) [back to overview] | Average TCS During the Entire RS |
| NCT02478398 (7) [back to overview] | Percentage of Participants Reporting Pre-specified Local Application Site Reactions |
| NCT02478398 (7) [back to overview] | Average Rhinoconjunctivitis (RC) DMS During the Peak RS |
| NCT02478398 (7) [back to overview] | Total Combined Score (TCS) During the Peak Ragweed Season (RS) |
| NCT02478398 (7) [back to overview] | Percentage of Participants Treated With Epinephrine |
| NCT02478398 (7) [back to overview] | Average Rhinoconjunctivitis (RC) DSS During the Peak RS |
| NCT02554786 (27) [back to overview] | Post Dose FEV1 (5 Minutes-1 Hour) |
| NCT02554786 (27) [back to overview] | Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category |
| NCT02554786 (27) [back to overview] | Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) |
| NCT02554786 (27) [back to overview] | Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52 |
| NCT02554786 (27) [back to overview] | Change Form Baseline in Percentage of Days With no Daytime Symptoms |
| NCT02554786 (27) [back to overview] | Change Form Baseline in Percentage of Mornings With no Symptoms on Awakening |
| NCT02554786 (27) [back to overview] | Duration in Days of Asthma Exacerbations by Exacerbation Category |
| NCT02554786 (27) [back to overview] | Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment |
| NCT02554786 (27) [back to overview] | Asthma Quality of Life Questionnaire (AQLQ) |
| NCT02554786 (27) [back to overview] | Change From Baseline in Percentage of Asthma Symptoms Free Days |
| NCT02554786 (27) [back to overview] | Change From Baseline in Percentage of Nights With no Night-time Awakenings |
| NCT02554786 (27) [back to overview] | Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations |
| NCT02554786 (27) [back to overview] | Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes |
| NCT02554786 (27) [back to overview] | Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations |
| NCT02554786 (27) [back to overview] | Time to First Hospitalization for Asthma Exacerbation |
| NCT02554786 (27) [back to overview] | Total Amounts of Systemic Corticosteroids (in Doses) Used to Treat Asthma Exacerbations |
| NCT02554786 (27) [back to overview] | Trough FEV1 at Week 52 |
| NCT02554786 (27) [back to overview] | Trough FEV1 Measured After 26 Weeks of Treatment |
| NCT02554786 (27) [back to overview] | Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52 |
| NCT02554786 (27) [back to overview] | Annual Rate of Asthma Exacerbations by Exacerbation Category |
| NCT02554786 (27) [back to overview] | Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26 |
| NCT02554786 (27) [back to overview] | Change From Baseline in Percentage of Rescue Medication Free Days |
| NCT02554786 (27) [back to overview] | Trough Forced Vital Capacity (FVC) |
| NCT02554786 (27) [back to overview] | Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75) |
| NCT02554786 (27) [back to overview] | Time to First Asthma Exacerbation by Exacerbation Category |
| NCT02554786 (27) [back to overview] | Rescue Medication Usage |
| NCT02554786 (27) [back to overview] | Pre-dose FEV1 at Weeks 4 and 12 |
| NCT02573233 (11) [back to overview] | Change From Baseline in Mast Cells Count (Tryptase Positive) in the Bronchial Submucosa at Week 12 |
| NCT02573233 (11) [back to overview] | Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
| NCT02573233 (11) [back to overview] | Pharmacokinetics (PK) Assessment: Serum Functional Dupilumab Concentration |
| NCT02573233 (11) [back to overview] | Change From Baseline in Mucin-Stained Area in the Bronchial Submucosa at Week 12 |
| NCT02573233 (11) [back to overview] | Change From Baseline in T-Helper Lymphocytes Count in the Bronchial Submucosa at Week 12 |
| NCT02573233 (11) [back to overview] | Change From Baseline in T-Lymphocytes Count in the Bronchial Submucosa at Week 12 |
| NCT02573233 (11) [back to overview] | Average Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 6 Through Week 12 |
| NCT02573233 (11) [back to overview] | Change From Baseline in Eosinophils Cells Count in the Bronchial Submucosa at Week 12 |
| NCT02573233 (11) [back to overview] | Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 12 |
| NCT02573233 (11) [back to overview] | Change From Baseline in Mast Cells Count (Chymase Positive) in the Bronchial Submucosa at Week 12 |
| NCT02573233 (11) [back to overview] | Number of Participants With Antidrug Antibodies (ADA) |
| NCT02631551 (1) [back to overview] | Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. |
| NCT02741271 (13) [back to overview] | Mean Change From Baseline in Total Daily Use of Short-Acting Beta-Agonist (SABA) Rescue Medication With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment |
| NCT02741271 (13) [back to overview] | Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60 |
| NCT02741271 (13) [back to overview] | Change From Baseline in AM Pre-Dose % Predicted FEV1 With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment |
| NCT02741271 (13) [back to overview] | Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment |
| NCT02741271 (13) [back to overview] | Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE |
| NCT02741271 (13) [back to overview] | Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to 12 Hours (AUC0-12) |
| NCT02741271 (13) [back to overview] | Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment |
| NCT02741271 (13) [back to overview] | Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate |
| NCT02741271 (13) [back to overview] | Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period |
| NCT02741271 (13) [back to overview] | Maximum Plasma Concentration (Cmax) of Mometsone Furoate |
| NCT02741271 (13) [back to overview] | Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE) |
| NCT02741271 (13) [back to overview] | Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to Time of Last Measurable Concentration (AUC0-last) |
| NCT02741271 (13) [back to overview] | Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period |
| NCT02874144 (5) [back to overview] | SNOT-22 (Sino-Nasal Outcome Test-22) Score |
| NCT02874144 (5) [back to overview] | Sinus CT Scan Scores by Lund-Mackay Scores |
| NCT02874144 (5) [back to overview] | BSIT (Brief Smell Identification Test) |
| NCT02874144 (5) [back to overview] | TOTAL POLYP SCORE (TPS) |
| NCT02874144 (5) [back to overview] | Visual Analog Scale (VAS) |
| NCT02880514 (2) [back to overview] | Patency Rate |
| NCT02880514 (2) [back to overview] | Inflammation Score |
| NCT02892344 (15) [back to overview] | The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period |
| NCT02892344 (15) [back to overview] | Rescue Medication Use Over 12 Weeks |
| NCT02892344 (15) [back to overview] | PEF Over 4 and 12 Weeks |
| NCT02892344 (15) [back to overview] | Trough FEV1 at Day 2 |
| NCT02892344 (15) [back to overview] | Trough FEV1 |
| NCT02892344 (15) [back to overview] | Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12 |
| NCT02892344 (15) [back to overview] | ACQ-7 at Week 4 |
| NCT02892344 (15) [back to overview] | ACQ-7 |
| NCT02892344 (15) [back to overview] | Pre-dose FEV1 at Week 4 |
| NCT02892344 (15) [back to overview] | Number of Patients With Asthma Exacerbation Over 12 Weeks |
| NCT02892344 (15) [back to overview] | Percentage of Rescue Medication Free Days Over 12 Weeks |
| NCT02892344 (15) [back to overview] | Percentage of Patients With ACQ-7 MID at Week 12 |
| NCT02892344 (15) [back to overview] | Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period |
| NCT02892344 (15) [back to overview] | FVC Over 12 Weeks |
| NCT02892344 (15) [back to overview] | Daily E-diary Over 12 Weeks |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in 22-item Sino-nasal Outcome Test (SNOT-22) Scores |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Asthma Control Questionnaire-6 (ACQ-6) for Participants With Asthma |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in European Quality of Life 5 Dimension Scale (EQ-5D) Visual Analog Scale Score |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Asthma |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Prior Nasal Polyp Surgery |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Nasal Peak Inspiratory Flow (NPIF) |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Nasal Polyp Score |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Asthma |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Prior Nasal Polyp Surgery |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay (LMK) Score |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Asthma |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Prior Nasal Polyp Surgery |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Rhinorrhea Daily Symptom Score |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Total Symptom Score (TSS) |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 24 in Visual Analogue Scale (VAS) for Rhinosinusitis |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in 22-item Sino-nasal Outcome Test Scores |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Asthma Control Questionnaire-6 for Participants With Asthma |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in European Quality of Life 5 Dimension Scale Visual Analog Scale Score |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Forced Expiratory Volume in 1 Second for Participants With Asthma |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Nasal Congestion/Obstruction Symptom Severity Score |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Asthma |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Prior Nasal Polyp Surgery |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Nasal Polyp Score |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Nasal Polyp Score: Subgroup of Participants With Asthma |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Opacification of Sinuses Measured by Lund-Mackay Score |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Prior Nasal Polyp Surgery |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Asthma |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Nasal Polyp Score: Subgroup of Participants With Prior Nasal Polyp Surgery |
| NCT02898454 (43) [back to overview] | Rescue Treatment Use: Estimate of Percentage of Participants With Greater Than or Equal to (>=) 1 Event by Week 52 Obtained Using Kaplan-Meier Method |
| NCT02898454 (43) [back to overview] | Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies Response (ADA) |
| NCT02898454 (43) [back to overview] | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation |
| NCT02898454 (43) [back to overview] | Functional Dupilumab Concentration in Serum |
| NCT02898454 (43) [back to overview] | Total Systemic Corticosteroids Rescue Intake Duration: Average Duration Per Participant |
| NCT02898454 (43) [back to overview] | Mean Total Systemic Corticosteroids Rescue Dose Prescribed During Treatment Period |
| NCT02898454 (43) [back to overview] | Changed From Baseline at Week 24 in Forced Expiratory Volume in 1 Second (FEV1) for Participants With Asthma |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Visual Analogue Scale for Rhinosinusitis |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Total Symptom Score |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in the University of Pennsylvania Smell Identification Test Score |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Severity of Decreased/Loss of Smell |
| NCT02898454 (43) [back to overview] | Change From Baseline at Week 52 in Rhinorrhea Daily Symptom Score |
| NCT02912468 (37) [back to overview] | Change From Baseline at Weeks 28, 32, 36, 40, 44 and 48 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily (Assessments Performed 4-24 Weeks After End of Treatment) |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in 22-item Sino-nasal Outcome Test (SNOT-22) Scores |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Visual Analogue Scale (VAS) for Rhinosinusitis |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Nasal Polyp Score |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Nasal Peak Inspiratory Flow (NPIF) |
| NCT02912468 (37) [back to overview] | Change From Baseline at Weeks 36 and 48 in 22-item Sino-nasal Outcome Test Scores (Assessments Performed 12 and 24 Weeks After End of Treatment) |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Nasal Congestion Symptom Severity Score: Subgroup of Participants With Prior Nasal Polyp Surgery |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Nasal Congestion Symptom Severity Score: Subgroup of Participants With Asthma |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Forced Expiratory Volume in 1 Second (FEV1) for Participants With Asthma |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in European Quality of Life 5 Dimension (EQ-5D) Visual Analog Scale Score |
| NCT02912468 (37) [back to overview] | Rescue Treatment Use: Estimate of Percentage of Participants With >=1 Event by Week 48 Obtained Using Kaplan-Meier Method |
| NCT02912468 (37) [back to overview] | Rescue Treatment Use: Estimate of Percentage of Participants With >=1 Event by Week 24 Obtained Using Kaplan-Meier Method |
| NCT02912468 (37) [back to overview] | Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies (ADA) Response |
| NCT02912468 (37) [back to overview] | Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation |
| NCT02912468 (37) [back to overview] | Functional Dupilumab Concentration in Serum |
| NCT02912468 (37) [back to overview] | Change From Baseline at Weeks 36 and 48 in Visual Analog Scale for Rhinosinusitis (Assessments Performed 12 and 24 Weeks After End of Treatment) |
| NCT02912468 (37) [back to overview] | Change From Baseline at Weeks 36 and 48 in Nasal Polyp Score (Assessments Performed 12 and 24 Weeks After End of Treatment) |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Rhinorrhea Daily Symptom Score |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Asthma Control Questionnaire-6 (ACQ-6) Scores for Participants With Asthma |
| NCT02912468 (37) [back to overview] | Change From Baseline at Weeks 28, 32, 36, 40, 44 and 48 in Total Symptom Score (Assessments Performed 4-24 Weeks After End of Treatment) |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Total Symptom Score (TSS) |
| NCT02912468 (37) [back to overview] | Change From Baseline at Weeks 28, 32, 36, 40, 44 and 48 in Rhinorrhea Daily Symptom Score (Assessments Performed 4-24 Weeks After End of Treatment) |
| NCT02912468 (37) [back to overview] | Change From Baseline at Weeks 28, 32, 36, 40, 44 and 48 in Nasal Congestion Symptom Severity Score (Assessments Performed 4-24 Weeks After End of Treatment) |
| NCT02912468 (37) [back to overview] | Total Systemic Corticosteroids Rescue Intake Duration: Average Duration Per Participant |
| NCT02912468 (37) [back to overview] | Mean Total Systemic Corticosteroids Rescue Dose Prescribed During Treatment Period |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 48 in University of Pennsylvania Smell Identification Test (Assessment Performed 24 Weeks After End of Treatment) |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 48 in Opacification of Sinuses Measured by Lund-Mackay Score (Assessment Performed 24 Weeks After End of Treatment) |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 48 in Forced Expiratory Volume in 1 Second for Participants With Asthma (Assessment Performed 24 Weeks After End of Treatment) |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 48 in Asthma Control Questionnaire-6 Scores for Participants With Asthma (Assessment Performed 24 Weeks After End of Treatment) |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund-Mackay (LMK) Score |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Prior Nasal Polyp Surgery |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Asthma |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Prior Nasal Polyp Surgery |
| NCT02912468 (37) [back to overview] | Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Asthma |
| NCT03085797 (8) [back to overview] | Percentage of Participants With Nasal Surgery Over Time |
| NCT03085797 (8) [back to overview] | Percentage of Participants Requiring at Least One Course of Systemic Steroids for Nasal Polyps up to Week 52 |
| NCT03085797 (8) [back to overview] | Change From Baseline in the Composite VAS Score (Combining VAS Scores for Nasal Obstruction, Nasal Discharge, Mucus in the Throat and Loss of Smell) During the 4 Weeks Prior to Week 52 |
| NCT03085797 (8) [back to overview] | Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52 |
| NCT03085797 (8) [back to overview] | Change From Baseline in Overall VAS Score During the 4 Weeks Prior to Week 52 |
| NCT03085797 (8) [back to overview] | Change From Baseline in Nasal Obstruction Visual Analog Scale (VAS) Score During the 4 Weeks Prior to Week 52 |
| NCT03085797 (8) [back to overview] | Change From Baseline in Total Endoscopic Nasal Polyps Score at Week 52 |
| NCT03085797 (8) [back to overview] | Change From Baseline in Individual VAS Symptom Score: Loss of Smell During the 4 Weeks Prior to Week 52 |
| NCT03401229 (35) [back to overview] | Total Number of Courses of SCS for NP |
| NCT03401229 (35) [back to overview] | Total Duration of SCS_NP (Days) |
| NCT03401229 (35) [back to overview] | Time to the First NP Surgery up to Week 56 |
| NCT03401229 (35) [back to overview] | Time to First SCS_NP up to Week 56 |
| NCT03401229 (35) [back to overview] | Time to First NP Surgery and/or SCS Use for NP to Week 56 |
| NCT03401229 (35) [back to overview] | Percentage of Subjects With SCS_NP |
| NCT03401229 (35) [back to overview] | Change From Baseline in Difficulty With Daily Activities Due to Nasal Symptoms at Week 40 |
| NCT03401229 (35) [back to overview] | Change From Baseline in Total NPS at Week 40 |
| NCT03401229 (35) [back to overview] | Change From Baseline in SF-36v2 Physical Component Summary at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in SF-36v2 Physical Functioning at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in SNOT-22 at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in SF-36v2 Role Limitations Due to Emotional Problems at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in SF-36v2 Role Limitations Due to Physical Health at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in SF-36v2 Social Functioning at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in SF-36v2 Vitality at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in SNOT-22 at Week 40 |
| NCT03401229 (35) [back to overview] | Change From Baseline in DSS at Week 40 |
| NCT03401229 (35) [back to overview] | Change From Baseline in Difficulty With Sleeping Due to Nasal Symptoms at Week 40 |
| NCT03401229 (35) [back to overview] | Change From Baseline in Sinus Severity Score at EOT/IPD |
| NCT03401229 (35) [back to overview] | Annual SCS_NP Use Rate Comparison by Period, Negative Binomial Model |
| NCT03401229 (35) [back to overview] | Percentage of Subjects With NP Surgery or SCS_NP |
| NCT03401229 (35) [back to overview] | Percentage of Subjects With NP Surgery |
| NCT03401229 (35) [back to overview] | Change From Baseline in UPSIT Score in Males at Week 40 |
| NCT03401229 (35) [back to overview] | Change From Baseline in UPSIT Score in Females at Week 40 |
| NCT03401229 (35) [back to overview] | Change From Baseline in DSS at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in LMS at EOT/IPD |
| NCT03401229 (35) [back to overview] | Change From Baseline in NBS at Week 40 |
| NCT03401229 (35) [back to overview] | Change From Baseline in NBS at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in NPS at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in SF-36v2 Bodily Pain at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in SF-36v2 General Health Perceptions at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in SF-36v2 Mental Component Summary at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in SF-36v2 Mental Health at Week 56 |
| NCT03401229 (35) [back to overview] | Change From Baseline in TSS at Week 40 |
| NCT03401229 (35) [back to overview] | Total SCS_NP Dose (a) Used (mg) |
| NCT03614923 (3) [back to overview] | Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16 |
| NCT03614923 (3) [back to overview] | Change From Baseline in Eosinophil Count |
| NCT03614923 (3) [back to overview] | Change From Baseline in Nasal Polyp Score (NPS) to Week 16 |
| NCT03705793 (3) [back to overview] | Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System |
| NCT03705793 (3) [back to overview] | Change in Sino-Nasal Outcome Test Scores (SNOT-22) |
| NCT03705793 (3) [back to overview] | Number of Participants Who Score <3 on the Clinical Global Impression Scale |
| NCT03855189 (28) [back to overview] | Change From Baseline in the TNSS At Day 15 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in the TNSS At Day 8 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in the TNSS At Day 4 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in the TNSS At Day 29 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in the TNSS At Day 22 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated) |
| NCT03855189 (28) [back to overview] | Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE) |
| NCT03855189 (28) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Number of Participants Who Experienced ≥1 Adverse Event |
| NCT03855189 (28) [back to overview] | Response To Therapy At Day 15 (Participant-Evaluated) |
| NCT03855189 (28) [back to overview] | Response To Therapy At Day 15 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Response To Therapy At Day 22 (Participant-Evaluated) |
| NCT03855189 (28) [back to overview] | Response To Therapy At Day 22 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Response To Therapy At Day 29 (Participant-Evaluated) |
| NCT03855189 (28) [back to overview] | Response To Therapy At Day 29 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Response To Therapy At Day 4 (Participant-Evaluated) |
| NCT03855189 (28) [back to overview] | Response To Therapy At Day 4 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Response To Therapy At Day 8 (Participant-Evaluated) |
| NCT03855189 (28) [back to overview] | Response To Therapy At Day 8 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated) |
| NCT03855189 (28) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated) |
| NCT03855228 (10) [back to overview] | Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician) |
| NCT03855228 (10) [back to overview] | Response to Therapy on Day 8 (Assessed by Physician) |
| NCT03855228 (10) [back to overview] | Response to Therapy on Day 15 (Assessed by Physician) |
| NCT03855228 (10) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician) |
| NCT03855228 (10) [back to overview] | Change From Baseline in Total Symptom Score (Assessed by Participant) |
| NCT03855228 (10) [back to overview] | Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician) |
| NCT03855228 (10) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician) |
| NCT03855228 (10) [back to overview] | Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) |
| NCT03855228 (10) [back to overview] | Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician) |
| NCT03855228 (10) [back to overview] | Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician) |
| NCT03861559 (21) [back to overview] | Baseline Overall Disease Condition Score for Calculation of Change From Baseline at Days 4, 8, and 15 as Assessed by Participant |
| NCT03861559 (21) [back to overview] | Baseline Total Nasal Symptom Score (TNSS) for Calculation of Change From Baseline at Days 4, 8, and 15 Visits as Assessed by Investigator |
| NCT03861559 (21) [back to overview] | Baseline Overall Disease Condition Score for Calculation of Change From Baseline at Days 4, 8, and 15 Visits as Assessed by Investigator |
| NCT03861559 (21) [back to overview] | Change From Baseline (CFB) in Overall Disease Condition Score at Day 15 as Assessed by Participant |
| NCT03861559 (21) [back to overview] | Baseline Total Nasal Symptom Score (TNSS) for Calculation of Change From Baseline Averaged Over 15 Days of Treatment as Assessed by Participant |
| NCT03861559 (21) [back to overview] | Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Investigator |
| NCT03861559 (21) [back to overview] | Therapeutic Response to Treatment at Day 8 as Assessed by Investigator |
| NCT03861559 (21) [back to overview] | Therapeutic Response to Treatment at Day 8 as Assessed by Participant |
| NCT03861559 (21) [back to overview] | Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Participant |
| NCT03861559 (21) [back to overview] | Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Investigator |
| NCT03861559 (21) [back to overview] | Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Participant |
| NCT03861559 (21) [back to overview] | Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 15 as Assessed by Investigator |
| NCT03861559 (21) [back to overview] | Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 4 as Assessed by Investigator |
| NCT03861559 (21) [back to overview] | Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator |
| NCT03861559 (21) [back to overview] | Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) Averaged Over 15 Days of Treatment, as Assessed by Participant |
| NCT03861559 (21) [back to overview] | Change From Baseline in Overall Disease Condition Score at Day 15 as Assessed by Investigator |
| NCT03861559 (21) [back to overview] | Median Time to Onset of Nasal Symptom Relief as Assessed by Participant Diary Responses |
| NCT03861559 (21) [back to overview] | Therapeutic Response to Treatment at Day 15 as Assessed by Investigator |
| NCT03861559 (21) [back to overview] | Therapeutic Response to Treatment at Day 15 as Assessed by Participant |
| NCT03861559 (21) [back to overview] | Therapeutic Response to Treatment at Day 4 as Assessed by Investigator |
| NCT03861559 (21) [back to overview] | Therapeutic Response to Treatment at Day 4 as Assessed by Participant |
| NCT03879772 (6) [back to overview] | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator |
| NCT03879772 (6) [back to overview] | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator |
| NCT03879772 (6) [back to overview] | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant |
| NCT03879772 (6) [back to overview] | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant |
| NCT03879772 (6) [back to overview] | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator |
| NCT03879772 (6) [back to overview] | Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator |
| NCT03882047 (11) [back to overview] | Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries) |
| NCT03882047 (11) [back to overview] | Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation) |
| NCT03882047 (11) [back to overview] | Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation) |
| NCT03882047 (11) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation) |
| NCT03882047 (11) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation) |
| NCT03882047 (11) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation) |
| NCT03882047 (11) [back to overview] | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation) |
| NCT03882047 (11) [back to overview] | Response to Therapy at Day 4 (Physician Evaluation) |
| NCT03882047 (11) [back to overview] | Response to Therapy at Day 4 (Participant Evaluation) |
| NCT03882047 (11) [back to overview] | Response to Therapy at Day 15 (Physician Evaluation) |
| NCT03882047 (11) [back to overview] | Response to Therapy at Day 15 (Participant Evaluation) |
| NCT04179461 (4) [back to overview] | Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC) |
| NCT04179461 (4) [back to overview] | Asthma Control Test (ACT) |
| NCT04179461 (4) [back to overview] | Adherence of Asthma Controller Medication |
| NCT04179461 (4) [back to overview] | Change in Composite Asthma Severity Index (CASI) |
| NCT04499235 (8) [back to overview] | The Percentage of Subjects Who Achieve Disease Control Without Rescue Therapy |
| NCT04499235 (8) [back to overview] | Total Cumulative Steroid Exposure |
| NCT04499235 (8) [back to overview] | Maximum Daily Steroid Dose |
| NCT04499235 (8) [back to overview] | Number of Participants With TEAEs, Assessed by Seriousness and Severity |
| NCT04499235 (8) [back to overview] | The Bullous Pemphigoid Disease Area Index (BPDAI) Score |
| NCT04499235 (8) [back to overview] | The Bullous Pemphigoid Disease Area Index Visual Analog Scale (BPDAI-VAS) |
| NCT04499235 (8) [back to overview] | Time to Rescue Therapy |
| NCT04499235 (8) [back to overview] | Time to Disease Control |
| NCT04589663 (3) [back to overview] | Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time Point 6h (AUC0-6h) of Mometasone Furoate |
| NCT04589663 (3) [back to overview] | Maximum Observed Mometasone Furoate Plasma Concentration (Cmax) |
| NCT04589663 (3) [back to overview] | Systemic Exposure to Indacaterol in Plasma |
Change From Baseline in Weekly Average Nighttime Awakenings Due to Asthma
Participants recorded the number of times during the night they awakened due to asthma. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Awakenings (Least Squares Mean) |
|---|
| Baseline | Change at Week 1 | Change at Week 2 | Change at Week 3 | Change at Week 4 | Change at Final Week |
|---|
| Mometasone | 0.6 | -0.1 | -0.1 | -0.3 | -0.2 | -0.2 |
,| Placebo | 0.6 | -0.2 | -0.2 | -0.3 | -0.3 | -0.3 |
Change From Baseline in AM and PM Chest Tightness Symptom Score
Chest tightness is an asthma symptom assessed by participants using diary cards to record morning and evening chest tightness (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her chest tightness for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). The severity of chest tightness was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline (AM) | Change at Week 1 (AM) | Change at Week 2 (AM) | Change at Week 3 (AM) | Change at Week 4 (AM) | Change at Final Week (AM) | Baseline (PM) | Change at Week 1 (PM) | Change at Week 2 (PM) | Change at Week 3 (PM) | Change at Week 4 (PM) | Change at Final Week (PM) |
|---|
| Mometasone | 1.6 | -0.2 | -0.3 | -0.5 | -0.5 | -0.4 | 1.6 | -0.3 | -0.4 | -0.6 | -0.6 | -0.6 |
,| Placebo | 1.6 | -0.4 | -0.4 | -0.7 | -0.7 | -0.6 | 1.6 | -0.5 | -0.5 | -0.7 | -0.7 | -0.6 |
Change From Baseline in AM and PM Cough Symptom Score
Cough is an asthma symptom assessed by participants who used diary cards to record morning and evening cough (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her coughing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Cough was rated on a 4-point scale (0=no symptoms [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). Reduction in score indicated an improvement in cough symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline (AM) | Change at Week 1 (AM) | Change at Week 2 (AM) | Change at Week 3 (AM) | Change at Week 4 (AM) | Change at Final Week (AM) | Baseline (PM) | Change at Week 1 (PM) | Change at Week 2 (PM) | Change at Week 3 (PM) | Change at Week 4 (PM) | Change at Final Week (PM) |
|---|
| Mometasone | 1.7 | -0.3 | -0.4 | -0.7 | -0.7 | -0.6 | 1.7 | -0.4 | -0.5 | -0.7 | -0.7 | -0.6 |
,| Placebo | 1.5 | -0.3 | -0.4 | -0.4 | -0.5 | -0.5 | 1.5 | -0.4 | -0.4 | -0.5 | -0.6 | -0.6 |
Change From Baseline in AM and PM Difficulty Breathing Symptom Score
Difficulty breathing is an asthma symptom assessed by participants using diary cards to record morning and evening difficulty breathing (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her difficulty breathing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Difficulty breathing was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline (AM) | Change at Week 1 (AM) | Change at Week 2 (AM) | Change at Week 3 (AM) | Change at Week 4 (AM) | Change at Final Week (AM) | Baseline (PM) | Change at Week 1 (PM) | Change at Week 2 (PM) | Change at Week 3 (PM) | Change at Week 4 (PM) | Change at Final Week (PM) |
|---|
| Mometasone | 1.7 | -0.3 | -0.4 | -0.7 | -0.7 | -0.6 | 1.7 | -0.3 | -0.4 | -0.6 | -0.7 | -0.6 |
,| Placebo | 1.6 | -0.3 | -0.4 | -0.6 | -0.7 | -0.6 | 1.6 | -0.4 | -0.5 | -0.6 | -0.7 | -0.6 |
Change From Baseline in AM and PM Nasal Congestion Symptom Score
Nasal congestion is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal congestion (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal congestion for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline (AM) | Change at Week 1 (AM) | Change at Week 2 (AM) | Change at Week 3 (AM) | Change at Week 4 (AM) | Change at Final Week (AM) | Baseline (PM) | Change at Week 1 (PM) | Change at Week 2 (PM) | Change at Week 3 (PM) | Change at Week 4 (PM) | Change at Final Week (PM) |
|---|
| Mometasone | 2.3 | -0.4 | -0.5 | -0.7 | -0.8 | -0.8 | 2.2 | -0.4 | -0.6 | -0.8 | -0.9 | -0.8 |
,| Placebo | 2.3 | -0.3 | -0.4 | -0.5 | -0.7 | -0.6 | 2.2 | -0.4 | -0.5 | -0.6 | -0.8 | -0.7 |
Change From Baseline in AM and PM Nasal Itching Symptom Score
Nasal itching is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal itching (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal itching for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline (AM) | Change at Week 1 (AM) | Change at Week 2 (AM) | Change at Week 3 (AM) | Change at Week 4 (AM) | Change at Final Week (AM) | Baseline (PM) | Change at Week 1 (PM) | Change at Week 2 (PM) | Change at Week 3 (PM) | Change at Week 4 (PM) | Change at Final Week (PM) |
|---|
| Mometasone | 2.0 | -0.4 | -0.6 | -0.9 | -0.9 | -0.8 | 1.7 | -0.4 | -0.7 | -0.9 | -0.9 | -0.8 |
,| Placebo | 1.9 | -0.2 | -0.3 | -0.5 | -0.6 | -0.5 | 1.5 | -0.3 | -0.4 | -0.6 | -0.7 | -0.6 |
Change From Baseline in AM and PM Nasal Sneezing Symptom Score
Nasal sneezing is a symptom of SAR assessed by participants using diary cards to record morning and evening nasal sneezing (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her nasal sneezing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). It was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms a were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline (AM) | Change at Week 1 (AM) | Change at Week 2 (AM) | Change at Week 3 (AM) | Change at Week 4 (AM) | Change at Final Week (AM) | Baseline (PM) | Change at Week 1 (PM) | Change at Week 2 (PM) | Change at Week 3 (PM) | Change at Week 4 (PM) | Change at Final Week (PM) |
|---|
| Mometasone | 1.8 | -0.5 | -0.6 | -0.9 | -0.9 | -0.8 | 1.9 | -0.5 | -0.7 | -0.9 | -0.9 | -0.9 |
,| Placebo | 1.7 | -0.2 | -0.6 | -0.4 | -0.6 | -0.6 | 1.8 | -0.4 | -0.5 | -0.6 | -0.7 | -0.7 |
Change From Baseline in AM and PM Peak Expiratory Flow Rate (PEFR)
Participants used a peak flow meter to measure the rate of air forcibly expelled from the lungs. They performed triplicate PEFR measurements in the morning prior to taking their study medication and again in the evening, and documented the highest of the three values in their diaries. A day with worsening asthma was any day during which a decrease from baseline in morning (AM) PEFR of more than 25% occurred. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Liters/min (Least Squares Mean) |
|---|
| Baseline (AM) | Change at Week 1 (AM) | Change at Week 2 (AM) | Change at Week 3 (AM) | Change at Week 4 (AM) | Change at Final Week (AM) | Baseline (PM) | Change at Week 1 (PM) | Change at Week 2 (PM) | Change at Week 3 (PM) | Change at Week 4 (PM) | Change at Final Week (PM) |
|---|
| Mometasone | 382.5 | 0.9 | 4.3 | 7.7 | 7.8 | 5.7 | 394.4 | 0.5 | 4.9 | 5.8 | 6.9 | 5.6 |
,| Placebo | 362.3 | 1.0 | 4.1 | 1.0 | 3.3 | 4.6 | 373.4 | 4.3 | 7.0 | 8.7 | 10.3 | 10.1 |
Change From Baseline in AM and PM Rhinorrhea Symptom Score
Rhinorrhea is a symptom of seasonal allergic rhinitis (SAR) assessed by participants using diary cards to record morning and evening rhinorrhea (recorded twice daily). Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her rhinorrhea for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Rhinorrhea was assessed on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline (AM) | Change at Week 1 (AM) | Change at Week 2 (AM) | Change at Week 3 (AM) | Change at Week 4 (AM) | Change at Final Week (AM) | Baseline (PM) | Change at Week 1 (PM) | Change at Week 2 (PM) | Change at Week 3 (PM) | Change at Week 4 (PM) | Change at Final Week (PM) |
|---|
| Mometasone | 2.2 | -0.3 | -0.5 | -0.7 | -0.9 | -0.8 | 2.1 | -0.4 | -0.5 | -0.8 | -0.9 | -0.8 |
,| Placebo | 2.1 | -0.2 | -0.3 | -0.4 | -0.5 | -0.5 | 2.0 | -0.3 | -0.4 | -0.5 | -0.6 | -0.5 |
Change From Baseline in AM and PM Total Nasal Symptom Severity (TNSS)
The Total Nasal Symptom Severity (TNSS) is the sum of severity scores for 4 nasal symptoms: nasal rhinorrhea, nasal stuffiness/congestion, sneezing, and nasal itching as assessed in the participant diaries. The severity of each nasal symptom was rated on a 4-point scale (0=no symptom [best score] to 3=symptoms were hard to tolerate and interfered with daily life activity [worst score]); minimum TNSS=0; maximum TNSS=12. A decrease in TNSS indicated an improvement in nasal symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline (AM) | Week 1 (AM) | Week 2 (AM) | Week 3 (AM) | Week 4 (AM) | Final Week (AM) | Baseline (PM) | Week 1 (PM) | Week 2 (PM) | Week 3 (PM) | Week 4 (PM) | Final Week (PM) |
|---|
| Mometasone | 8.4 | -1.7 | -2.3 | -3.2 | -3.5 | -3.1 | 8.2 | -1.8 | -2.6 | -3.4 | -3.6 | -3.3 |
,| Placebo | 7.9 | -0.9 | -1.3 | -1.8 | -2.4 | -2.2 | 7.9 | -1.5 | -1.8 | -2.4 | -2.8 | -2.6 |
Change From Baseline in AM and PM Wheeze Symptom Score
Wheezing is a symptom of asthma. The wheezing assessment was based on participant diary data only. Every morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her wheezing for the time period since the last evaluation (or for the previous 12 hours for the first evaluation). Wheeze severity was rated on a 4-point scale (0=no wheezing [best score] to 3=wheezing was hard to tolerate and interfered with daily life activity [worst score]). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline (AM) | Change at Week 1 (AM) | Change at Week 2 (AM) | Change at Week 3 (AM) | Change at Week 4 (AM) | Change at Final Week (AM) | Baseline (PM) | Change at Week 1 (PM) | Change at Week 2 (PM) | Change at Week 3 (PM) | Change at Week 4 (PM) | Change at Final Week (PM) |
|---|
| Mometasone | 1.5 | -0.2 | -0.4 | -0.6 | -0.6 | -0.5 | 1.5 | -0.3 | -0.4 | -0.6 | -0.7 | -0.6 |
,| Placebo | 1.3 | -0.3 | -0.3 | -0.5 | -0.6 | -0.5 | 1.3 | -0.4 | -0.4 | -0.5 | -0.6 | -0.5 |
Change From Baseline in Forced Expiratory Flow (FEF) Between 25% and 75% of the Vital Capacity (FEF25%-75%)
Measured by the investigator (or a designated assistant) using a spirometer, FEF25%-75% is the average forcibly expelled air flow rate, measured between 75% and 25% of FVC. (NCT00070707)
Timeframe: Baseline, Day 15 and Day 29
| Intervention | Liters/sec (Least Squares Mean) |
|---|
| Baseline | Change at Day 15 | Change at Day 29 |
|---|
| Mometasone | 2.98 | 0.12 | 0.15 |
,| Placebo | 3.00 | 0.00 | 0.03 |
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Measured by the investigator (or a designated assistant) using a spirometer, FEV1 is the volume of air forcibly expelled from the lungs in one second. (NCT00070707)
Timeframe: Baseline, Day 15 and Day 29
| Intervention | Liters (Least Squares Mean) |
|---|
| Baseline | Change at Day 15 | Change at Day 29 |
|---|
| Mometasone | 2.98 | 0.05 | 0.04 |
,| Placebo | 3.00 | 0.07 | 0.02 |
Change From Baseline in Forced Vital Capacity (FVC)
Measured by the investigator (or a designated assistant) using a spirometer, FVC is the total volume of air forcibly expelled from the lungs after taking the deepest breath possible. (NCT00070707)
Timeframe: Baseline, Day 15 and Day 29
| Intervention | Liters (Least Squares Mean) |
|---|
| Baseline | Change at Day 15 | Change at Day 29 |
|---|
| Mometasone | 3.75 | 0.02 | -0.00 |
,| Placebo | 3.80 | 0.00 | 0.00 |
Change From Baseline in Morning (AM) and Evening (PM) Total Asthma Symptom Severity (TASS)
Each morning prior to dosing and each evening approximately 12 hours later, the participant evaluated his/her asthma symptoms. The TASS was the sum of severity scores for 4 asthma symptoms: cough, wheeze, difficulty of breathing, and chest tightness. The severity of each asthma symptom was rated on a 4-point scale (0=no symptom; 3=severe); minimum TASS=0; maximum TASS=12. A decrease in TASS indicated an improvement in asthma symptoms. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline (AM) | Change at Week 1 (AM) | Change at Week 2 (AM) | Change at Week 3 (AM) | Change at Week 4 (AM) | Change at Final Week (AM) | Baseline (PM) | Change at Week 1 (PM) | Change at Week 2 (PM) | Change at Week 3 (PM) | Change at Week 4 (PM) | Change at Final Week (PM) |
|---|
| Mometasone | 6.5 | -0.9 | -1.5 | -2.4 | -2.5 | -2.2 | 6.6 | -1.4 | -1.7 | -2.6 | -2.7 | -2.4 |
,| Placebo | 5.9 | -1.4 | -1.5 | -2.1 | -2.6 | -2.2 | 6.0 | -1.7 | -1.7 | -2.3 | -2.5 | -2.4 |
Change From Baseline in Pulmonary Auscultation/Wheezing Assessment
Wheezing was assessed by the investigator or designee based upon pulmonary auscultation (listening with a stethoscope) and reported in the case report form as present or absent. The count of wheezing presence (yes, no) at visits was summarized. (NCT00070707)
Timeframe: Baseline, Day 15 and Day 29
| Intervention | Participants (Count of Participants) |
|---|
| Present at Baseline | Absent at Baseline | Present on Day 15 | Absent on Day 15 | Present on Day 29 | Absent on Day 29 |
|---|
| Mometasone | 11 | 101 | 8 | 94 | 10 | 98 |
,| Placebo | 9 | 66 | 4 | 68 | 3 | 71 |
Change From Baseline in the Weekly Average Number of Puffs of Albuterol/Salbutamol Used
Once daily, participants recorded in their diaries the total number of puffs of albuterol/salbutamol used in each 24-hour period. The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Number of puffs (Least Squares Mean) |
|---|
| Baseline | Change at Week 1 | Change at Week 2 | Change at Week 3 | Change at Week 4 | Change at Final Week |
|---|
| Mometasone | 2.4 | -0.4 | -0.6 | -0.8 | -0.7 | -0.7 |
,| Placebo | 2.1 | -0.5 | -0.5 | -0.5 | -0.6 | -0.6 |
Change From Baseline in Weekly Average Interference With Daily Activities
Interference with daily activities was rated once each evening using a 4-point scale ranging from 0 (none) to 3 (substantially interfered with activities or not able to perform the activities at all). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline | Change at Week 1 | Change at Week 2 | Change at Week 3 | Change at Week 4 | Change at Final Week |
|---|
| Mometasone | 1.5 | -0.3 | -0.4 | -0.6 | -0.6 | -0.5 |
,| Placebo | 1.4 | -0.4 | -0.3 | -0.4 | -0.5 | -0.5 |
Change From Baseline in Weekly Average Interference With Sleep
Interference with sleep was rated once each morning using a 4-point scale ranging from 0 (none) to 3 (substantially interferes with sleep). The Final Week was the final 7 days post Day 1 (e. g., if Day 20 was the day of last dose of study medication, then the AM assessment at Final Week was calculated from Day 14 to Day 20, and the PM assessment at Final Week was calculated from Day 13 to Day 19). (NCT00070707)
Timeframe: Baseline up to Week 4
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline | Change at Week 1 | Change at Week 2 | Change at Week 3 | Change at Week 4 | Change at Final Week |
|---|
| Mometasone | 1.3 | -0.2 | -0.4 | -0.5 | -0.5 | -0.4 |
,| Placebo | 1.2 | -0.2 | -0.3 | -0.4 | -0.5 | -0.4 |
Therapeutic Response to SAR Nasal Symptoms
On Day 15 and Day 29, the investigator or designee and participant jointly assessed the participant's response to study intervention by comparing the current level of SAR symptoms with those noted on Day 1. Therapeutic response for SAR symptoms was based on a 5-point scale ranging from 1 (Complete Relief) to 5 (No Relief). (NCT00070707)
Timeframe: Day 15 and Day 29
| Intervention | Score on a scale (Mean) |
|---|
| SAR Nasal: Day 15 | SAR Nasal: Day 29 |
|---|
| Mometasone | 3.2 | 3.0 |
,| Placebo | 3.4 | 3.4 |
Therapeutic Response to Asthma Symptoms
On Day 15 and Day 29, the investigator or designee and participant jointly assessed the participant's response to study intervention by comparing the current level of asthma symptoms with those noted on Day 1. Therapeutic response for asthma symptoms was based on a 5-point scale ranging from 1 (Complete Relief) to 5 (No Relief). (NCT00070707)
Timeframe: Day 15 and Day 29
| Intervention | Score on a scale (Mean) |
|---|
| Asthma: Day 15 | Asthma: Day 29 |
|---|
| Mometasone | 3.4 | 3.2 |
,| Placebo | 3.4 | 3.5 |
Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score.
"The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12.~NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate." (NCT00358527)
Timeframe: Average of the last 7 days of treatment
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| Change from Baseline in TNSS score | Baseline TNSS score |
|---|
| Mometasone Furoate Nasal Spray | -3.77 | 9.10 |
,| Placebo Nasal Spray. | -3.07 | 9.12 |
Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit.
"Following Visit 2 (Screening), at Baseline, Day 15, and Day 29 visits, participants needed to complete the MOS-SS questionnaire with scores from 1 = all of the time to 6 = none of the time, according to their frequency of occurrence during the previous week. The analysis endpoint MOS-SS Sleep Problems Index II (SLP9) score was derived from MOS-SS questionnaire and scaled from 0 = none of the time to 100 = all of the time.~NOTE: Least squares means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate." (NCT00358527)
Timeframe: 29 days
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| Change from baseline in SLP9 score | Baseline SLP9 Score |
|---|
| Mometasone Furoate Nasal Spray | -26.1 | 68.6 |
,| Placebo Nasal Spray. | -25.8 | 69.2 |
Apnea-Hypopnea Index
Apnea-Hypopnea Index (AHI), used to assess severity of sleep apnea based on total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. Determined by the frequency of occurrence of apnea-hypopnea episodes measured during sleep at home by an Embletta device. (NCT00359216)
Timeframe: change from baseline (screening) at the end of 28 days of treatment
| Intervention | apnea-hypopnea episodes per hour (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 1.0 |
| Placebo Nasal Spray | 1.6 |
Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks
An increase between visits indicates improved nasal airflow. (NCT00361439)
Timeframe: baseline and 2 weeks
| Intervention | liters per minute (Median) |
|---|
| Mometasone | 19.2 |
| Placebo | -37.5 |
Histological Findings
Number of eosinophils per high-powered field (HPF) in olfactory biopsy taken after 2 weeks of study treatment (higher values indicate greater inflammation); average of three HPF reported (NCT00361439)
Timeframe: 2 weeks
| Intervention | eosinophils per HPF (Median) |
|---|
| Mometasone | 0.167 |
| Placebo | 2.67 |
Change From Baseline in Total Nasal Symptom Score at 2 Weeks
A decrease in scores between visits signifies an improvement in nasal symptoms. The total nasal symptom score can range from 0 to 27. (NCT00361439)
Timeframe: baseline and 2 weeks
| Intervention | units on a scale (Median) |
|---|
| Mometasone | -12 |
| Placebo | -5 |
Change From Baseline in Percentage of Eosinophils at 2 Weeks
"A decrease between visits signifies a reduction in inflammation.~Calculated from cytology specimens obtained by lavage." (NCT00361439)
Timeframe: baseline and 2 weeks
| Intervention | percentage of eosinophils (Median) |
|---|
| Mometasone | -1.35 |
| Placebo | -0.1 |
Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine
The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine). (NCT00378378)
Timeframe: Baseline to Endpoint
| Intervention | mcg/hour (Least Squares Mean) |
|---|
| Baseline | Baseline to Endpoint |
|---|
| MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years | 6.7 | 0.0 |
,| MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years | 5.3 | 1.0 |
,| Pooled Placebo | 7.6 | -0.6 |
Change From Baseline 24-hour Urinary Free Cortisol Level
The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to <18 years of age. Primary safety was to be assessed by determining the subject's 24-hour urinary free cortisol level. (NCT00378378)
Timeframe: Baseline to Endpoint
| Intervention | mcg/hour (Least Squares Mean) |
|---|
| Baseline | Change from Baseline to Endpoint |
|---|
| MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years | 49.5 | 1.5 |
,| MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years | 39.6 | 11.6 |
,| Pooled Placebo | 49.8 | -2.1 |
The Number of All Randomized Subjects Reporting Adverse Events (AEs).
AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results. (NCT00379288)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Treatment-Emergent Adverse Events (TEAE) | Related Adverse Events | Severe Adverse Events | Serious Adverse Events |
|---|
| F/SC 250/50 mcg BID | 56 | 16 | 4 | 4 |
,| F/SC 500/50 mcg BID | 50 | 13 | 4 | 2 |
,| MF/F 200/10 mcg BID | 109 | 40 | 8 | 7 |
,| MF/F 400/10 mcg BID | 103 | 30 | 5 | 8 |
Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma That Require Use of Short-Acting Beta Agonists (SABA)
Baseline was the proportion of nights of the last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0 = no awakenings to 1 = awakenings every night. The comparison was for MF/F versus placebo. Standard deviation was pooled. (NCT00381485)
Timeframe: 12-week Treatment Period
| Intervention | Proportion of nights (Least Squares Mean) |
|---|
| MF/F MDI 400/10 mcg BID | -0.10 |
| MF/F MDI 200/10 mcg BID | -0.10 |
| MF MDI 400 mcg BID | -0.05 |
Change From Baseline to Week 12 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score
AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The AQLQ(S) Total score was the mean of the individual 32 questions. The comparison was for MF/F versus placebo. Standard deviation was pooled. (NCT00381485)
Timeframe: Baseline to Week 12
| Intervention | Units on a Scale (Least Squares Mean) |
|---|
| MF/F MDI 400/10 mcg BID | 0.51 |
| MF/F MDI 200/10 mcg BID | 0.61 |
| MF MDI 400 mcg BID | 0.50 |
Change From Baseline to Week 12 in Asthma Control Questionnaire (ACQ) Total Score
ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The ACQ Total score was the mean of the individual seven questions. The comparison was for MF/F versus placebo. Standard deviation was pooled. (NCT00381485)
Timeframe: Baseline to Week 12
| Intervention | Units on a Scale (Least Squares Mean) |
|---|
| MF/F MDI 400/10 mcg BID | -0.58 |
| MF/F MDI 200/10 mcg BID | -0.59 |
| MF MDI 400 mcg BID | -0.42 |
Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)
The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F versus MF. Standard deviation was pooled. (NCT00381485)
Timeframe: Baseline to Week 12
| Intervention | Liter x hour (Least Squares Mean) |
|---|
| MF/F MDI 400/10 mcg BID | 4.19 |
| MF/F MDI 200/10 mcg BID | 3.59 |
| MF MDI 400 mcg BID | 2.04 |
Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ[S]) Total Score
AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). Standard deviations are pooled. (NCT00383240)
Timeframe: Baseline to Week 26
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Baseline (n=183/189/187/189, respectively) | Change from Baseline to Endpoint (26 weeks) |
|---|
| F MDI 10 mcg BID | 5.51 | 0.05 |
,| MF MDI 200 mcg BID | 5.40 | 0.37 |
,| MF/F MDI 200/10 mcg BID | 5.38 | 0.49 |
,| Placebo BID | 5.56 | -0.01 |
Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Score
ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). (NCT00383240)
Timeframe: Baseline to week 26
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Baseline (n=179/186/184/187, respectively) | Change from Baseline to Endpoint (week 26) |
|---|
| F MDI 10 mcg BID | 1.43 | 0.11 |
,| MF MDI 200 mcg BID | 1.46 | -0.23 |
,| MF/F MDI 200/10 mcg BID | 1.47 | -0.40 |
,| Placebo BID | 1.41 | 0.14 |
Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) for MF/F Versus MF
(NCT00383240)
Timeframe: Baseline to Endpoint (12 weeks)
| Intervention | liters x hours (Least Squares Mean) |
|---|
| Baseline (n=188/189/198/192, respectively) | Endpoint (Change from Baseline) |
|---|
| F MDI 10 mcg BID | 2.73 | 1.60 |
,| MF MDI 200 mcg BID | 1.29 | 1.31 |
,| MF/F MDI 200/10 mcg BID | 3.20 | 3.19 |
,| Placebo BID | 1.42 | 0.51 |
Number of Participants With at Least One Severe Asthma Exacerbation
"A severe asthma exacerbation was defined as a clinically judged deterioration of asthma or a meaningful reduction in lung function based on any of the following criteria during the Treatment Period:~A decrease in FEV1 below the Treatment Period stability limit at any visit,~A decrease in AM or PM peak flow below the Treatment Period stability limits on any 2 consecutive days,~An occurrence of any clinical deterioration of asthma (ie, asthma attack) that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication." (NCT00383240)
Timeframe: Baseline to Week 26
| Intervention | participants (Number) |
|---|
| MF/F MDI 200/10 mcg BID | 58 |
| MF MDI 200 mcg BID | 65 |
| F MDI 10 mcg BID | 109 |
| Placebo BID | 109 |
Time-to-first Asthma Exacerbation Over the 26-week Treatment Period for the Comparison of MF/F Versus F
This endpoint was to measure the time it took for 50% of subjects in a treatment arm to experience a severe asthma exacerbation (also see the posted Other Pre-specified Outcome: Number of Participants With at Least One Severe Asthma Exacerbation) (NCT00383240)
Timeframe: 26-week Treatment Period
| Intervention | days (Median) |
|---|
| MF/F MDI 200/10 mcg BID | NA |
| MF MDI 200 mcg BID | NA |
| F MDI 10 mcg BID | 92 |
| Placebo BID | 131 |
Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta 2-agonist (SABA)
Baseline is the proportion of nights of last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. Standard deviation is pooled. (NCT00383240)
Timeframe: Baseline to Endpoint
| Intervention | Ratio (Least Squares Mean) |
|---|
| Baseline (n=186/191/199/194, respectively) | Change from Baseline to Endpoint |
|---|
| F MDI 10 mcg BID | 0.16 | 0.01 |
,| MF MDI 200 mcg BID | 0.16 | -0.05 |
,| MF/F MDI 200/10 mcg BID | 0.18 | -0.08 |
,| Placebo BID | 0.15 | 0.00 |
Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)
FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward. (NCT00383435)
Timeframe: Baseline to Endpoint (13 weeks)
| Intervention | Liters (Least Squares Mean) |
|---|
| Baseline | Endpoint (Change from Baseline) |
|---|
| F MDI 10 mcg BID | 1.252 | 0.077 |
,| MF MDI 400 mcg BID | 1.255 | 0.057 |
,| MF/F MDI 200/10 mcg BID | 1.227 | 0.126 |
,| MF/F MDI 400/10 mcg BID | 1.186 | 0.166 |
,| Placebo | 1.227 | 0.003 |
Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1
"Endpoint was the last post-baseline non-missing result through Week 13 carried~forward." (NCT00383435)
Timeframe: Baseline to Endpoint (13 weeks)
| Intervention | Liters (Least Squares Mean) |
|---|
| Baseline | Endpoint (Change from Baseline) |
|---|
| F MDI 10 mcg BID | 1.252 | 0 |
,| MF MDI 400 mcg BID | 1.258 | 0.027 |
,| MF/F MDI 200/10 mcg BID | 1.223 | 0.058 |
,| MF/F MDI 400/10 mcg BID | 1.191 | 0.111 |
,| Placebo | 1.230 | -0.017 |
Number of Participants With Mild, Moderate, or Severe COPD Exacerbations
Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more nebulized treatments/day of inhaled rescue medication. Moderate = treatment with antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event. (NCT00383435)
Timeframe: Endpoint (26 weeks)
| Intervention | Participants (Number) |
|---|
| Mild | Moderate | Severe |
|---|
| F MDI 10 mcg BID | 45 | 30 | 4 |
,| MF MDI 400 mcg BID | 41 | 30 | 1 |
,| MF/F MDI 200/10 mcg BID | 48 | 23 | 0 |
,| MF/F MDI 400/10 mcg BID | 41 | 14 | 1 |
,| Placebo | 41 | 25 | 3 |
Number of Participants With Partly Stable COPD
"Partly stable COPD was a composite measure that included the following COPD~outcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or~treatment-related adverse event as determined by the investigator." (NCT00383435)
Timeframe: Endpoint (26 weeks)
| Intervention | Participants (Number) |
|---|
| MF/F MDI 400/10 mcg BID | 82 |
| MF/F MDI 200/10 mcg BID | 95 |
| MF MDI 400 mcg BID | 83 |
| F MDI 10 mcg BID | 90 |
| Placebo | 85 |
Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)
Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period. (NCT00383435)
Timeframe: Baseline to Endpoint (26 weeks)
| Intervention | Proportion of symptom-free nights (Least Squares Mean) |
|---|
| Baseline | Endpoint (Change from Baseline) |
|---|
| F MDI 10 mcg BID | 0.35 | 0.14 |
,| MF MDI 400 mcg BID | 0.33 | 0.11 |
,| MF/F MDI 200/10 mcg BID | 0.29 | 0.07 |
,| MF/F MDI 400/10 mcg BID | 0.31 | 0.15 |
,| Placebo | 0.31 | 0.06 |
Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score
SGRQ consisted of 76 items aggregated into 3 component scores: symptoms (frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), & total score. Best health scores have a low numeric value. All component scores & total score range from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint is the last post-baseline non-missing result through the 26 week evaluation carried forward. (NCT00383435)
Timeframe: Baseline to Endpoint (26 weeks)
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline | Endpoint (Change from Baseline) |
|---|
| F MDI 10 mcg BID | 44.87 | -6.18 |
,| MF MDI 400 mcg BID | 47.00 | -6.99 |
,| MF/F MDI 200/10 mcg BID | 45.89 | -5.69 |
,| MF/F MDI 400/10 mcg BID | 45.05 | -7.43 |
,| Placebo | 44.60 | -2.87 |
AUC(0-12 Hour) of the Change From Baseline to Week 12 in FEV1 for Each Body Mass Index (BMI) Subgroup
The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. BMI is a number calculated from a person's weight and height. The higher the number, the higher the amount of fat. The comparison was for MF/F vs placebo. Standard deviation was pooled. (NCT00383552)
Timeframe: Baseline to Week 12
| Intervention | liters * hours (Least Squares Mean) |
|---|
| Less than 25 | 25 to less than 30 | 30 or more |
|---|
| F MDI 10 mcg BID | 4.34 | 4.26 | 3.13 |
,| MF MDI 100 mcg BID | 3.19 | 3.23 | 1.69 |
,| MF/F MDI 100/10 mcg BID | 5.24 | 3.36 | 3.35 |
,| Placebo BID | 2.22 | 1.22 | -0.73 |
Change From Baseline in AM FEV1 Pre-dose Assessment, or Trough FEV1, at Week 12
Trough FEV1 is a measure of the end-of-dosing interval. The comparison was for MF/F vs F. Standard deviation was pooled. (NCT00383552)
Timeframe: Baseline to Week 12
| Intervention | liters (Least Squares Mean) |
|---|
| Baseline | Change from Baseline |
|---|
| F MDI 10 mcg BID | 2.47 | 0.11 |
,| MF MDI 100 mcg BID | 2.41 | 0.16 |
,| MF/F MDI 100/10 mcg BID | 2.50 | 0.18 |
,| Placebo BID | 2.46 | 0.04 |
Change From Baseline in Proportion of Nights Across the Treatment Period With Nocturnal Awakenings Due to Asthma Which Require Use of Short-acting Beta Agonists (SABA)
Baseline is the proportion of nights of the last week (Days -7 to 1) prior to first dose with nocturnal awakenings. Scale is measured as 0 to 1 with 0=no awakenings to 1=awakenings every night. The comparison was for MF/F vs placebo. Standard deviation was pooled. (NCT00383552)
Timeframe: Baseline to Endpoint
| Intervention | Proportion of Nights (Least Squares Mean) |
|---|
| Baseline | Change from Baseline |
|---|
| F MDI 10 mcg BID | 0.15 | -0.03 |
,| MF MDI 100 mcg BID | 0.12 | -0.03 |
,| MF/F MDI 100/10 mcg BID | 0.13 | -0.06 |
,| Placebo BID | 0.13 | 0.02 |
Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)
The average of the two predose FEV1 measurements (30 minutes prior to dosing and 0 hour, immediately prior to dosing) at the Baseline Visit were subtracted from each of the serial measurements over the 12-hour period. The AUC was calculated based on these changes from Baseline evaluations. The comparison was for MF/F vs MF. Standard deviation was pooled. (NCT00383552)
Timeframe: Baseline to Week 12
| Intervention | liters * hours (Least Squares Mean) |
|---|
| Baseline | Change from Baseline |
|---|
| F MDI 10 mcg BID | 4.09 | 3.83 |
,| MF MDI 100 mcg BID | 1.85 | 2.53 |
,| MF/F MDI 100/10 mcg BID | 3.94 | 4.00 |
,| Placebo BID | 1.64 | 1.11 |
Change From Baseline to Week 26 in Asthma Quality of Life Questionnaire With Standarized Activities (AQLQ[S]) Total Score
AQLQ(S) consists of 32 questions each scaled from 1 (worst case) to 7 (best case). The comparison was for MF/F vs placebo. Standard deviation was pooled. (NCT00383552)
Timeframe: Baseline to Week 26
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Baseline | Change from Baseline |
|---|
| F MDI 10 mcg BID | 5.60 | 0.15 |
,| MF MDI 100 mcg BID | 5.65 | 0.39 |
,| MF/F MDI 100/10 mcg BID | 5.60 | 0.44 |
,| Placebo BID | 5.76 | 0.06 |
Number of Participants With at Least One Severe Asthma Exacerbation at Week 26
Severe asthma exacerbation refers to an occurrence of a decrease below 80% of Baseline in FEV1, a decrease below 70% of Baseline in PEF on 2 consecutive days and or a clinical deterioration of asthma resulting in emergency treatment, hospitalization or treatment with asthma medication. (NCT00383552)
Timeframe: Week 26
| Intervention | participants (Number) |
|---|
| MF/F MDI 100/10 mcg BID | 30 |
| MF MDI 100 mcg BID | 53 |
| F MDI 10 mcg BID | 84 |
| Placebo BID | 86 |
Change From Baseline to Week 26 in the Asthma Control Questionnaire (ACQ) Total Score
ACQ consists of seven questions each scaled from 0 (best case) to 6 (worst case). The comparison was for MF/F vs placebo. Standard deviation was pooled. (NCT00383552)
Timeframe: Baseline to Week 26
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Baseline | Change from Baseline |
|---|
| F MDI 10 mcg BID | 1.38 | -0.12 |
,| MF MDI 100 mcg BID | 1.29 | -0.32 |
,| MF/F MDI 100/10 mcg BID | 1.34 | -0.40 |
,| Placebo BID | 1.23 | -0.11 |
Number of Participants With Partly Stable COPD
"Partly stable COPD was a composite measure that included the following COPD~outcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly~average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or treatment-related adverse event as determined by the investigator." (NCT00383721)
Timeframe: Endpoint (26 weeks)
| Intervention | Participants (Number) |
|---|
| MF/F MDI 400/10 mcg BID | 91 |
| MF/F MDI 200/10 mcg BID | 101 |
| MF MDI 400 mcg BID | 92 |
| F MDI 10 mcg BID | 98 |
| Placebo | 87 |
Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)
Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period. (NCT00383721)
Timeframe: Baseline to Endpoint (26 weeks)
| Intervention | Proportion of symptom-free nights (Least Squares Mean) |
|---|
| Baseline | Endpoint (Change from Baseline) |
|---|
| F MDI 10 mcg BID | 0.25 | 0.13 |
,| MF MDI 400 mcg BID | 0.24 | 0.16 |
,| MF/F MDI 200/10 mcg BID | 0.22 | 0.17 |
,| MF/F MDI 400/10 mcg BID | 0.24 | 0.13 |
,| Placebo | 0.24 | 0.12 |
Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score
"SGRQ consisted of 76 items aggregated into 3 component scores: symptoms~(frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), & total score. Best health scores have a low numeric value. All component scores & total score ranged from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint was the last post-baseline non-missing result through the 26 week evaluation carried forward." (NCT00383721)
Timeframe: Baseline to Endpoint (26 weeks)
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline | Endpoint (Change from Baseline) |
|---|
| F MDI 10 mcg BID | 46.27 | -4.93 |
,| MF MDI 400 mcg BID | 48.27 | -5.87 |
,| MF/F MDI 200/10 mcg BID | 47.29 | -7.99 |
,| MF/F MDI 400/10 mcg BID | 48.22 | -6.04 |
,| Placebo | 46.59 | -2.88 |
Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)
FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward. (NCT00383721)
Timeframe: Baseline to Endpoint (13 weeks)
| Intervention | Liters (Least Squares Mean) |
|---|
| Baseline | Endpoint (Change from Baseline) |
|---|
| F MDI 10 mcg BID | 1.176 | 0.092 |
,| MF MDI 400 mcg BID | 1.260 | 0.053 |
,| MF/F MDI 200/10 mcg BID | 1.195 | 0.139 |
,| MF/F MDI 400/10 mcg BID | 1.189 | 0.179 |
,| Placebo | 1.205 | 0.018 |
Number of Participants With Mild, Moderate, or Severe COPD Exacerbations
"Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more~nebulized treatments/day of inhaled rescue medication. Moderate = treatment with~antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event." (NCT00383721)
Timeframe: Endpoint (26 weeks)
| Intervention | Participants (Number) |
|---|
| Mild | Moderate | Severe |
|---|
| F MDI 10 mcg BID | 61 | 33 | 2 |
,| MF MDI 400 mcg BID | 49 | 29 | 5 |
,| MF/F MDI 200/10 mcg BID | 53 | 20 | 3 |
,| MF/F MDI 400/10 mcg BID | 56 | 24 | 3 |
,| Placebo | 64 | 38 | 4 |
Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1
Endpoint was the last post-baseline non-missing result through Week 13 carried forward. (NCT00383721)
Timeframe: Baseline to Endpoint (13 weeks)
| Intervention | Liters (Least Squares Mean) |
|---|
| Baseline | Endpoint (Change from Baseline) |
|---|
| F MDI 10 mcg BID | 1.175 | 0.049 |
,| MF MDI 400 mcg BID | 1.255 | 0.028 |
,| MF/F MDI 200/10 mcg BID | 1.194 | 0.063 |
,| MF/F MDI 400/10 mcg BID | 1.188 | 0.098 |
,| Placebo | 1.205 | -0.003 |
Mean Percent Change in the Left Total Femur From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point
The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward. (NCT00394355)
Timeframe: Baseline and up to ~ one year of treatment
| Intervention | percentage of BMD (Mean) |
|---|
| MF DPI 200 mcg QD PM | 0.3 |
| MF DPI 400 mcg QD PM | 0.2 |
| FP MDI 250 mcg BID | 0.2 |
| ML 10 mg QD PM | 0.5 |
Summary of Change From Baseline to Endpoint in FEV1 (Forced Expiratory Volume in One Second).
Mean percent change from Baseline (the last non-missing value prior to treatment) in pulmonary function test FEV1 from in-office visits and at Endpoint (last non-missing postbaseline value carried forward) (NCT00394355)
Timeframe: Baseline and up to ~ one year of treatment
| Intervention | percentage of FEV1 (Mean) |
|---|
| MF DPI 200 mcg QD PM | 0.29 |
| MF DPI 400 mcg QD PM | 0.38 |
| FP MDI 250 mcg BID | 0.31 |
| ML 10 mg QD PM | 0.19 |
Mean Percent Change in Lumbar Spine Bone Mineral Density (BMD) From the Averaged Baseline Value to the Endpoint of Treatment Time Point
The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward. (NCT00394355)
Timeframe: Baseline and up to ~ one year of treatment
| Intervention | percentage of BMD (Mean) |
|---|
| MF DPI 200 mcg QD PM | 0.7 |
| MF DPI 400 mcg QD PM | 0.9 |
| FP MDI 250 mcg BID | 1.1 |
| ML 10 mg QD PM | 1.2 |
Mean Percent Change in the Femoral Neck BMD From the Averaged Baseline Value to the Averaged Value at the Endpoint of Treatment Time Point
The averaged baseline value is the average of the two scan results prior to treatment. The endpoint of treatment time point is the average of the last two valid post baseline BMD scans during the treatment period carried forward. (NCT00394355)
Timeframe: Baseline and up to ~ one year of treatment
| Intervention | percentage of BMD (Mean) |
|---|
| MF DPI 200 mcg QD PM | -0.2 |
| MF DPI 400 mcg QD PM | 0.4 |
| FP MDI 250 mcg BID | -0.4 |
| ML 10 mg QD PM | -0.2 |
Onset-of-action Based on Change From Baseline FEV1 at the 5 Min Pulmonary Function Test (PFT) Assessment on Day 1
PFTs, including FEV1, were done on Day 1. Evaluations included 30 min before and immediately before the first dose, the mean of which was Baseline, and at intervals from 5 min to 12 hrs postdose. Onset of action was defined as statistically significant improvement of MF/F over F/SC in Change from Baseline FEV1 at the 5-min postdose evaluation on Day 1. The same series of PFTs were done at Week 12. Change from Baseline to Week 12 evaluations were calculated using the same Day 1 predose scores for Baseline. The Week-12 evaluation consisted of AUC FEV1 scores across the 12-hour postdose interval. (NCT00424008)
Timeframe: Baseline to 5 minutes post-dose on Day 1
| Intervention | Liters (Least Squares Mean) |
|---|
| MF/F MDI 200/10 mcg BID | 0.20 |
| F/SC DPI 250/50 mcg BID | 0.09 |
Change From Baseline in Asthma Control Questionnaire (ACQ) Total Score at Week 12 Endpoint
The Asthma Control Questionnaire (ACQ) by Juniper et al. is a mean of 7 equally weighted composite scores; each scaled from 0=best case scenario to 6=worst case scenario on an integer scale. Composites include the following: How Often Woken by Asthma, How Bad Were Asthma Symptoms When You Woke, Activity Limitations, Shortness of Breath, Wheezing, Average Daily Short-Acting Beta 2-Agonist (SABA) Puffs, and physician-evaluated lung function. With the exception of physician-evaluated lung function collected at the visit, evaluations were over the last week recall period. (NCT00424008)
Timeframe: Baseline to Week 12
| Intervention | Scores on a scale (Least Squares Mean) |
|---|
| MF/F MDI 200/10 mcg BID | -0.65 |
| F/SC DPI 250/50 mcg BID | -0.65 |
The Proportion of Symptom-free Days and Nights (Combined) Over the 12-week Treatment Period.
For each day of the evaluation period, symptoms were collected in the morning for the night's evaluation, and in the evening for the day's evaluation. Symptoms included coughing, wheezing, and difficulty breathing, each integer-scaled from 0=none to 3=severe. A symptom-free Day/Night is defined as a combined score of 0 across the morning and evening evaluations. The proportion of 0 scores across the Baseline period, and across the 12-week treatment period, is calculated to determine the overall proportion of symptom-free Days/Nights for each of these periods. (NCT00424008)
Timeframe: Baseline to Week 12
| Intervention | Proportion of symptom-free days/nights (Least Squares Mean) |
|---|
| Baseline (over the last week prior to first dose) | Actual proportion over the 12-wk treatment period | Change from Baseline to over the 12-wk tx period |
|---|
| F/SC DPI 250/50 mcg BID | 0.18 | 0.43 | 0.25 |
,| MF/F MDI 200/10 mcg BID | 0.19 | 0.42 | 0.24 |
The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hr) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1)
(NCT00424008)
Timeframe: Baseline to Week 12
| Intervention | Liter x hour (Least Squares Mean) |
|---|
| MF/F MDI 200/10 mcg BID | 3.43 |
| F/SC DPI 250/50 mcg BID | 3.24 |
Skin Toxicity as Measured by a Dermatologic Quality-of-life Instrument (Skindex-16).
Patient-Reported Mean of the Maximum Total a Skindex-16 Toxicity Score per patient on a 0-6 scale during radiation treatment (Lower score indicates less toxicity). (NCT00438659)
Timeframe: During Radiation Treatment, up to a maximum of 11 weeks.
| Intervention | score on a 0-6 scale (Mean) |
|---|
| Mometasone | 1.4 |
| Placebo | 1.7 |
Adverse Events Assessed Clinically by NCI CTCAE v3.0
(NCT00438659)
Timeframe: During Radiation Treatment, up to a maximum of 9 weeks.
| Intervention | participants (Number) |
|---|
| ARTHRALGIA: Severe | BURN: Mild | BURN: Moderate | BURN: Severe | CELLULITES INFECTN: Moderate | COUGH: Severe | DERMATOLOGY: Mild | DERMATOLOGY: Moderate | DERMATOLOGY: Severe | FATIGUE: Moderate | PAIN: Severe | PAIN-BREAST: Moderate | PAIN-CHEST: Moderate | PRURITUS: Mild | PRURITUS: Moderate | PRURITUS: Severe | SKIN ATROPHY: Mild | SKIN ATROPHY: Moderate | SKIN HYPOPIGMENT: Mild | SKIN HYPOPIGMENT: Moderate | SKIN IRRITATION: Moderate | SKIN STRIAE: Mild | SKIN STRIAE: Moderate |
|---|
| Mometasone | 1 | 32 | 6 | 0 | 1 | 0 | 11 | 8 | 0 | 0 | 0 | 1 | 0 | 36 | 14 | 1 | 0 | 1 | 5 | 1 | 0 | 2 | 1 |
,| Placebo | 0 | 32 | 5 | 2 | 1 | 1 | 19 | 3 | 2 | 1 | 1 | 1 | 1 | 50 | 14 | 5 | 2 | 0 | 8 | 1 | 1 | 6 | 0 |
Adverse Events Reported by the Patient in the Symptom Experience Diary (SED).
Maximum SED score during radiation treatment per patient on a 0 to 10 scale (lower score is better) (NCT00438659)
Timeframe: During Radiation Treatment, up to a maximum of 11 weeks.
| Intervention | units on a scale (Mean) |
|---|
| Redness | Dry Peeling | Wet Peeling | Weeping | Rash | Swelling | Fatigue | Decrease in color | Band, Stripes or Lines |
|---|
| Mometasone | 5.1 | 2.7 | 1.3 | 1.2 | 2.6 | 2.3 | 4.5 | 2.3 | 1.7 |
,| Placebo | 6.8 | 3.1 | 1.6 | 1.4 | 4.0 | 2.4 | 5.0 | 2.1 | 1.5 |
Incidence of Severe ( Grade >=3) Radiation Dermatitis
To compare incidence of severe (Grade ≥ 3) radiation dermatitis as measured by the CTCAE v3.0 for the mometasone and placebo arms. (NCT00438659)
Timeframe: During Radiation Treatment, up to a maximum of 9 weeks.
| Intervention | Paticipants (Number) |
|---|
| Did not experience grade >=3 radiation dermatitis | Experience grade >=3 radiation dermatitis |
|---|
| Mometasone | 80 | 4 |
,| Placebo | 78 | 4 |
QOL Domains as Measured by LASA
Mean scores of Linear Analogue Sef-Assessment (LASA) Mental, physical, emotional, social, spiritual wel-being on a 0 (as bad as it can be) to 100 (as good as it can be) scale. (NCT00438659)
Timeframe: During Radiation Treatment, up to a maximum of 11 weeks.
| Intervention | units on a scale (Mean) |
|---|
| Mental well-being | Physical well-being | Emotional well-being | Social well-being | Spiritual well-being |
|---|
| Mometasone | 86 | 83 | 85 | 81 | 89 |
,| Placebo | 84 | 79 | 80 | 77 | 84 |
Overall Quality of Life (QOL) as Measured by Linear Analogue Self-Assessment (LASA)
Patient completed QOL assessment was the Linear Analogue Self-Assessment (LASA). This instrument consisted of 6 questions with responses ranging from 0 (poor QOL) to 100 (best QOL). (NCT00438659)
Timeframe: During Radiation Treatment, up to a maximum of 11 weeks.
| Intervention | units on a scale (Mean) |
|---|
| Mometasone | 85 |
| Placebo | 82 |
Mean Maximum Grade of Radiation Dermatitis by Treatment Arm.
Maximum grade of radiation dermatitis as measured by the Common Terminology Criteria (CTCAE) for Adverse Events (AE), Version 3.0. Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe AE), Grade 4 (Life-threatening or disabling AE), Grade 5 (Death related to AE). (NCT00438659)
Timeframe: During Radiation Treatment, up to a maximum of 9 weeks.
| Intervention | Grade (Mean) |
|---|
| Mometasone | 1.2 |
| Placebo | 1.3 |
Mean Percent Change of AM PEFR (Peak Exploratory Flow Rate) From Baseline to Week 12.
The AM PEFR measurement at the Baseline visit was compared to the AM PEFR measurement during the last visit at Week 12. The mean percent change was calculated. (NCT00442117)
Timeframe: Baseline and Week 12
| Intervention | Percent Change of AM PEFR (Mean) |
|---|
| MF-DPI | 2.59 |
| BUD-DPI | 1.93 |
Mean Percent Change of FVC (Forced Vital Capacity) From Baseline to Week 12.
The FVC measurement at the baseline was compared to the FVC measurement during the last visit at Week 12. The mean percent change was calculated. (NCT00442117)
Timeframe: Baseline and Week 12
| Intervention | Percent Change of FVC (Mean) |
|---|
| MF-DPI | -0.11 |
| BUD-DPI | -0.88 |
Mean Percent Change of Forced Expiratory Volume in One Second (FEV1) From Baseline to Week 12.
FEV1 (forced expiratory volume in one second) measurement at the Baseline visit was compared to the FEV1 measurement during the last visit at Week 12. The mean percent change was calculated. (NCT00442117)
Timeframe: Baseline and Week 12
| Intervention | Percent Change of FEV1 (Mean) |
|---|
| MF-DPI | -1.09 |
| BUD-DPI | -0.02 |
Mean Percent Change of Forced Expiratory Flow (FEF) at (25-75% Interval) From Baseline to Week 12.
The FEF (25-75%) measurement at the baseline was compared to the FEF (25-75%) measurement during the last visit at Week 12. The mean percent change was calculated. (NCT00442117)
Timeframe: Baseline and Week 12
| Intervention | Percent Change of FEF (Mean) |
|---|
| MF-DPI | 0.01 |
| BUD-DPI | 1.72 |
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)
The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants. (NCT00453063)
Timeframe: Baseline and 15 days
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Baseline RQLQ Total Score | Change from Baseline in RQLQ Total Score |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 4.19 | -1.63 |
,| Placebo | 4.42 | -1.36 |
Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15
TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12. (NCT00453063)
Timeframe: Baseline and 15 days
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Baseline TNSS | Change from Baseline in TNSS |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 9.83 | -2.36 |
,| Placebo | 9.69 | -1.71 |
Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15
Nasal congestion was one of the symptoms measured in the TNSS and was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3. (NCT00453063)
Timeframe: Baseline and 15 days
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Baseline Nasal Congestion Score | Change from Baseline in Nasal Congestion Score |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 2.66 | -0.54 |
,| Placebo | 2.64 | -0.39 |
Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15
Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow. (NCT00453063)
Timeframe: Baseline and 15 days
| Intervention | liters/minute (Least Squares Mean) |
|---|
| Baseline PNIF | Change from Baseline in PNIF |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 89.11 | 10.15 |
,| Placebo | 88.85 | 8.24 |
Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15
TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 9. (NCT00453063)
Timeframe: Baseline and 15 days
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Baseline TOSS | Change from Baseline in TOSS |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 7.07 | -1.52 |
,| Placebo | 7.01 | -1.36 |
Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15
TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9. (NCT00468312)
Timeframe: Screening through 15 days daily
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline TOSS | Change from Baseline in TOSS |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 6.78 | -1.71 |
,| Placebo | 6.74 | -1.37 |
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)
The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants. (NCT00468312)
Timeframe: Baseline and 15 days
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline RQLQ Total Score | Change from Baseline in RQLQ Total Score |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 4.27 | -1.81 |
,| Placebo | 4.28 | -1.08 |
Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15
Nasal congestion was one of the symptoms measures in the TNSS and was scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3. (NCT00468312)
Timeframe: Screening through 15 days daily
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline Nasal Congestion Score | change from Baseline in Nasal Congestion Score |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 2.60 | -0.59 |
,| Placebo | 2.62 | -0.39 |
Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15
Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow. (NCT00468312)
Timeframe: Screening through 15 days daily
| Intervention | liters/minute (Least Squares Mean) |
|---|
| Baseline PNIF | Change from Baseline in PNIF |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 93.12 | 16.55 |
,| Placebo | 91.96 | 12.59 |
Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15
TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12. (NCT00468312)
Timeframe: Screening through 15 days daily
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Baseline TNSS | Change from Baseline in TNSS |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 9.31 | -2.54 |
,| Placebo | 9.31 | -1.66 |
The Change From Baseline in the Number of Apnea-hypopnea Episodes Per Hour (Apnea-hypopnea Index (AHI)
(NCT00491374)
Timeframe:
| Intervention | (Number) |
|---|
| Placebo | 0 |
| Mometasone Furoate Nasal Spray | 0 |
Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1
Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea & itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, & disturbing some of the time; 3=Severe: sign/symptom very noticeable & very bothersome most of the time. (NCT00491504)
Timeframe: Baseline and 6 hours following initial dosing
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Mometasone Furoate Nasal Spray 200 mcg | -2.01 |
| Placebo | -1.86 |
Change From Baseline in the Average AM Peak Expiratory Flow (PEF) Over the 7 Days of Week 8.
Week 8 End = The last 7 days of data with the last day within the range of Days 51 to 64. (NCT00521599)
Timeframe: Baseline and Week 8 End
| Intervention | liters/minute (Least Squares Mean) |
|---|
| Baseline | Week 8 End |
|---|
| MF DPI 1 x 200 mcg BID | 374.3 | 7.65 |
,| MF DPI 2 x 100 mcg BID | 361.8 | 6.03 |
,| Placebo BID | 348.4 | -7.93 |
Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)
The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0 (no symptoms and no rescue medication use) to 54 (most severe symptoms and maximum use of rescue medication), with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0 (best) to 18 (worst), with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0 (no rescue medication use) to 36 (maximum use of rescue medication), with a lower score indicating less use of rescue medication. (NCT00550550)
Timeframe: From the Start of the GPS to the End of the GPS
| Intervention | Units on a Scale (Mean) |
|---|
| SCH 697243 | 4.62 |
| Placebo | 6.25 |
Participant Average Rhinoconjunctivitis Daily Symptom Scores (DSS) Over the Entire GPS
The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 (best) to 18 (worst). (NCT00550550)
Timeframe: Start of the GPS to the End of the GPS
| Intervention | Units on a Scale (Mean) |
|---|
| SCH 697243 | 3.71 |
| Placebo | 4.91 |
Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ) Total Score Over the Entire GPS
The RQLQ has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0 (best) to 6 (worst), with a higher score indicating more significant impairment. (NCT00550550)
Timeframe: Start of the GPS to the End of the GPS
| Intervention | Units on a Scale (Mean) |
|---|
| SCH 697243 | 1.45 |
| Placebo | 1.77 |
Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS
The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0 (no use of rescue medication) to 36 (maximum use of rescue medication). A lower medication score indicated less impact on symptoms and was suggestive of less use of rescue medication. (NCT00550550)
Timeframe: Start of the GPS to the End of the GPS
| Intervention | Units on a Scale (Mean) |
|---|
| SCH 697243 | 0.91 |
| Placebo | 1.33 |
Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
Tympanometry was performed in children ages 2-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (normal pressure in the middle ear with normal mobility of the eardrum and the conduction bones) , abnormal (abnormal pressure in the middle ear and/or abnormal mobility of the eardrum and the conduction bones), or tympanometry was not done (evaluation not completed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment). (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Participants (Number) |
|---|
| Visit 2- Normal (n=66 MFNS, n=66 Placebo) | Visit 2- Abnormal (n=66 MFNS, n=66 Placebo) | Visit 2- Not Done (n=66 MFNS, n=66 Placebo) | Visit 3- Normal (n=65 MFNS, n=65 Placebo) | Visit 3- Abnormal (n=65 MFNS, n=65 Placebo) | Visit 3- Not Done (n=65 MFNS, n=65 Placebo) | Visit 4- Normal (n=62 MFNS, n=60 Placebo) | Visit 4- Abnormal (n=62 MFNS, n=60 Placebo) | Visit 4- Not Done (n=62 MFNS, n=60 Placebo) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 35 | 25 | 6 | 44 | 14 | 7 | 45 | 16 | 1 |
,| Placebo Nasal Spray | 39 | 22 | 5 | 33 | 22 | 10 | 39 | 19 | 2 |
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance
"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate expiratory nasal airway resistance reported in Pascal/centimeter^3/second (Pa/cm^3/sec)." (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Pa/cm^3/sec (Mean) |
|---|
| Visit 2- Left Nasal Fossa (n=19, n=20) | Visit 3- Left Nasal Fossa (n=18, n=18) | Visit 4- Left Nasal Fossa (n=19, n=19) | Visit 2- Right Nasal Fossa (n=19, n=20) | Visit 3- Right Nasal Fossa (n=18, n=18) | Visit 4- Right Nasal Fossa (n=19, n=19) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 1.771 | 2.937 | 13.488 | 2.625 | 2.189 | 0.961 |
,| Placebo Nasal Spray | 3.994 | 1.478 | 4.148 | 1.083 | 3.646 | 2.792 |
Number of Participants With Otoscopic Results of: Normal or Abnormal
Otoscopic examination was performed of the right and left ear canals at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on audiologist's assessment as either being normal (ear canal structures appear normal) or abnormal (ear canal structures appear abnormal). (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Participants (Number) |
|---|
| Right Otoscopy: Visit 2- Normal (n=66, n=66) | Right Otoscopy: Visit 2- Abnormal (n=66, n=66) | Right Otoscopy Visit 3- Normal (n=65, n=65) | Right Otoscopy Visit 3- Abnormal (n=65, n=65) | Right Otoscopy Visit 4- Normal (n=62, n=60) | Right Otoscopy Visit 4- Abnormal (n=62, n=60) | Left Otoscopy: Visit 2- Normal (n=66, n=66) | Left Otoscopy: Visit 2- Abnormal (n=66, n=66) | Left Otoscopy Visit 3- Normal (n=65, n=65) | Left Otoscopy Visit 3- Abnormal (n=65, n=65) | Left Otoscopy Visit 4- Normal (n=62, n=60) | Left Otoscopy Visit 4- Abnormal (n=62, n=60) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 50 | 16 | 54 | 11 | 49 | 13 | 49 | 17 | 51 | 14 | 48 | 14 |
,| Placebo Nasal Spray | 51 | 15 | 53 | 12 | 52 | 8 | 52 | 14 | 55 | 10 | 52 | 8 |
Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa
"Acoustic rhinometry examination of the left & right Nasal Fossa was performed by principal investigators at baseline & each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.~Measurements were taken for each side of the nose (nasopharyngeal minimum cross-sectional area) & were reported in cm^3." (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | cm^3 (Mean) |
|---|
| Visit 2- Left Nasal Fossa (n=19, n=20) | Visit 3- Left Nasal Fossa (n=18, n=18) | Visit 4- Left Nasal Fossa (n=19, n=19) | Visit 2- Right Nasal Fossa (n=19, n=20) | Visit 3- Right Nasal Fossa (n=18, n=18) | Visit 4- Right Nasal Fossa (n=19, n=19) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 0.599 | 0.608 | 0.662 | 0.532 | 0.581 | 0.734 |
,| Placebo Nasal Spray | 0.491 | 0.594 | 0.661 | 0.577 | 0.596 | 0.814 |
Total Severity Symptom Scores: Morning and Evening (AM & PM)
Symptoms were assessed by whole-number linear scale to grade their severity. Scores were recorded AM & PM (a difference of 12 hours) & were based on severity within 12 hours of prior recording. The following symptoms were evaluated: Snoring; Nasal obstruction & discharge; Breathing difficulty; Oral respiration; Ear pain. Severity was graded according to the following scale: 0=absent; 1=mild; 2=moderate; 3=severe. Severity was scored individually and summed to obtain the Total Symptom Severity Score. The maximum total score possible was 36 daily; 18 for both AM (6 symptoms times max severity of 3)and PM. (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Score on a scale (Mean) |
|---|
| Visit 2 AM (n=66 MFNS, n=66 Placebo) | Visit 3 AM (n=64 MFNS, n=65 Placebo) | Visit 4 AM (n=62 MFNS, n=60 Placebo) | Visit 2 PM (n=66 MFNS, n=66 Placebo) | Visit 3 PM (n=64 MFNS, n=65 Placebo) | Visit 4 PM (n=62 MFNS, n=60 Placebo) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 9.4 | 5.4 | 4.2 | 9.9 | 6.3 | 4.8 |
,| Placebo Nasal Spray | 9.9 | 6.4 | 5.5 | 10.2 | 7.0 | 5.7 |
Total Frequency Symptom Scores: AM & PM
Symptoms were assessed by whole-number linear scale to grade their frequency. Scores were recorded AM & PM (a difference of 12 hours) & were based on frequency within 12 hours of prior recording. The following signs/symptoms were evaluated: Snoring; Nasal obstruction; and nasal discharge; Breathing difficulty; Oral respiration; Ear pain. Frequency was graded according to the following scale: 0=absent; 1=intermittent; 2=persistent. The frequency of symptoms was scored individually and summed to obtain the Total Frequency Symptom Score. The maximum total score possible was 24 daily; 12 for both AM (6 symptoms times max frequency of 2) and PM. (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Score on a scale (Mean) |
|---|
| Visit 2 AM (n=66 MFNS, n=66 Placebo) | Visit 3 AM (n=64 MFNS, n=65 Placebo) | Visit 4 AM (n=62 MFNS, n=60 Placebo) | Visit 2 PM (n=66 MFNS, n=66 Placebo) | Visit 3 PM (n=64 MFNS, n=65 Placebo) | Visit 4 PM (n=62 MFNS, n=60 Placebo) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 7.3 | 4.4 | 3.7 | 7.6 | 5.3 | 4.1 |
,| Placebo Nasal Spray | 7.3 | 5.4 | 4.4 | 8.0 | 5.7 | 4.6 |
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance
"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate inspiratory nasal airway resistance reported in Pascal/centimeter^3/second (Pa/cm^3/sec)." (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Pa/cm^3/sec (Mean) |
|---|
| Visit 2- Left Nasal Fossa (n=19, n=20) | Visit 3- Left Nasal Fossa (n=18, n=18) | Visit 4- Left Nasal Fossa (n=19, n=19) | Visit 2- Right Nasal Fossa (n=19, n=20) | Visit 3- Right Nasal Fossa (n=18, n=18) | Visit 4- Right Nasal Fossa (n=19, n=19) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 2.111 | 6.341 | 31.074 | 2.985 | 1.823 | 2.560 |
,| Placebo Nasal Spray | 3.280 | 1.934 | 54.724 | 6.535 | 3.026 | 43.621 |
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa
"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Inspiration flow was calculated at 75 Pa." (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | cm^3/sec (Mean) |
|---|
| Visit 2- Left Nasal Fossa (n=19, n=20) | Visit 3- Left Nasal Fossa (n=18, n=18) | Visit 4- Left Nasal Fossa (n=19, n=19) | Visit 2- Right Nasal Fossa (n=19, n=20) | Visit 3- Right Nasal Fossa (n=18, n=18) | Visit 4- Right Nasal Fossa (n=19, n=19) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 200.530 | 222.152 | 194.208 | 183.562 | 228.661 | 215.400 |
,| Placebo Nasal Spray | 178.933 | 151.268 | 172.346 | 161.958 | 197.266 | 183.368 |
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa
"Rhinomanometry examination of the left & right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years.~Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Expiratory flow was calculated at 75 Pa." (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | cm^3/sec (Mean) |
|---|
| Visit 2- Left Nasal Fossa (n=19, n=20) | Visit 3- Left Nasal Fossa (n=18, n=18) | Visit 4- Left Nasal Fossa (n=19, n=19) | Visit 2- Right Nasal Fossa (n=19, n=20) | Visit 3- Right Nasal Fossa (n=18, n=18) | Visit 4- Right Nasal Fossa (n=19, n=19) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 190.024 | 225.911 | 181.026 | 160.531 | 209.676 | 195.108 |
,| Placebo Nasal Spray | 166.930 | 173.139 | 192.374 | 166.302 | 209.787 | 176.587 |
Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)
The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. This modular instrument consists of 23 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL. (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Score on a scale (Mean) |
|---|
| Visit 2 (n= 15 MFNS, n=13 Placebo) | Visit 3 (n=15 MFNS, n= 14 Placebo) | Visit 4 (n=15 MFNS, n=13 Placebo) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 76.014 | 82.971 | 85.725 |
,| Placebo Nasal Spray | 76.839 | 84.006 | 83.946 |
Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa
Acoustic rhinometry examination of the left & right Nasal Fossa was performed by principal investigators at baseline & each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities. (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | cm^3 (Mean) |
|---|
| Visit 2- Left Nasal Fossa (n=19, n=20) | Visit 3- Left Nasal Fossa (n=18, n=18) | Visit 4- Left Nasal Fossa (n=19, n=19) | Visit 2- Right Nasal Fossa (n=19, n=20) | Visit 3- Right Nasal Fossa (n=19, n=18) | Visit 4- Right Nasal Fossa (n=19, n=19) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 4.245 | 3.725 | 3.631 | 3.566 | 4.183 | 3.774 |
,| Placebo Nasal Spray | 4.117 | 3.489 | 3.084 | 4.489 | 4.884 | 3.275 |
Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)
The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. This modular instrument consists of 21 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL. (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Score on a scale (Mean) |
|---|
| Visit 2 (n= 23 MFNS, n=29 Placebo) | Visit 3 (n=22 MFNS, n= 28 Placebo) | Visit 4 (n=18 MFNS, n=25 Placebo) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 78.442 | 80.438 | 80.137 |
,| Placebo Nasal Spray | 78.017 | 78.486 | 82.701 |
Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score
"18 items of the survey were graded on a 7-point ordinal scale. Caregivers were asked to describe how often in the last 4 weeks had the child exhibited specific symptoms according to the following scale: 1: none of the time; 2: hardly any of the time; 3: a little of the time; 4: some of the time; 5: a good bit of the time; 6: most of the time; 7: all of the time. All scores were summed (total score: 18-126).~Grading was as follows:~Scores < 60 suggest a slight impact on health related quality of life (HRQL)~Scores 60-80 suggest a moderate impact~Scores over 80 suggest a great impact" (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Score on a scale (Mean) |
|---|
| Visit 2 (n=66 MFNS, n=65 Placebo) | Visit 3 (n=65 MFNS, n= 65 Placebo) | Visit 4 (n=62 MFNS, n= 59 Placebo) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 62.742 | 47.138 | 42.742 |
,| Placebo Nasal Spray | 60.169 | 48.769 | 43.068 |
Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic
Rhinoscopic examination of the inferior turbinates was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being normal appearance (normal size) , hypertrophic (swollen/normal size increased), or hypotrophic (normal size diminished). (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Participants (Number) |
|---|
| Visit 2- Normal Appearance (n=66, n=66) | Visit 2 Hypertrophic (n=66, n=66) | Vist 2 Hypotrophic (n=66, n=66) | Visit 3 Normal Appearance (n=65, n=65) | Visit 3 Hypertrophic (n=65, n=65) | Visit 3 Hypotrophic (n=65, n=65) | Visit 4 Normal Appearance (n=62, n=60) | Visit 4 Hypertrophic (n=62, n=60) | Visit 4 Hypotrophic (n=62, n=60) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 50 | 16 | 0 | 46 | 19 | 0 | 45 | 17 | 0 |
,| Placebo Nasal Spray | 46 | 20 | 0 | 48 | 17 | 0 | 42 | 18 | 0 |
Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation
Rhinoscopic examination of the septum was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being aligned (septum is aligned), non-obstructive (septum is not aligned but the deviation is non-obstructive), or obstructive (septum is deviated and obstructive) deviation. (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Participants (Number) |
|---|
| Visit 2 Aligned (n= 66, n=66) | Visit 2 Non-obstructive Deviation (n= 66, n=66) | Vist 2 Obstructive Deviation (n=66, n=66) | Visit 3 Aligned (n=65, n=65) | Visit 3 Non-obstructive Deviation (n=65, n=65) | Visit 3 Obstructive Deviation (n=65, n=65) | Visit 4 Aligned (n=62, n=60) | Visit 4 Non-obstructive Deviation (n=62, n=60) | Visit 4 -Obstructive Deviation (n=62, n=60) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 65 | 1 | 0 | 64 | 1 | 0 | 61 | 1 | 0 |
,| Placebo Nasal Spray | 63 | 3 | 0 | 62 | 3 | 0 | 57 | 3 | 0 |
Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction
Rhinoscopic examination of the middle meatus was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment into 3 categories: patent (easily observed), partial obstruction (partially blocked from view), or total obstruction (completely blocked from view). (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Participants (Number) |
|---|
| Visit 2- Patent (n=66, n=66) | Visit 2- Partial Obstruction (n=66, n=66) | Visit 2- Total Obstruction (n=66, n=66) | Visit 3- Patent (n=65, n=65) | Visit 3- Partial Obstruction (n=65, n=65) | Visit 3- Total Obstruction (n=65, n=65) | Visit 4- Patent (n=62, n=60) | Visit 4- Partial Obstruction (n= 62, n=60) | Visit 4- Total Obstruction (n=62, n=60) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 62 | 3 | 1 | 61 | 4 | 0 | 56 | 6 | 0 |
,| Placebo Nasal Spray | 60 | 5 | 1 | 61 | 2 | 2 | 53 | 4 | 3 |
Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done
Pure-tone audiometry was performed in children ages 7-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (within normal limits), abnormal (outside normal limits), or audiometry was not done (not performed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment). (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Participants (Number) |
|---|
| Visit 2- Normal (n=19 MFNS, n=21 Placebo) | Visit 2- Abnormal (n=19 MFNS, n=21 Placebo) | Visit 2- Not Done (n=19 MFNS, n= 21 Placebo) | Visit 3- Normal (n=20 MFNS, n=21 Placebo) | Visit 3- Abnormal (n=20 MFNS, n=21 Placebo) | Visit 3- Not Done (n=20 MFNS, n=21 Placebo) | Visit 4- Normal (n=19 MFNS, n=20 Placebo) | Visit 4- Abnormal (n=19 MFNS, n=20 Placebo) | Visit 4- Not Done (n=19 MFNS, n=20 Placebo) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 13 | 5 | 1 | 15 | 4 | 1 | 15 | 2 | 2 |
,| Placebo Nasal Spray | 18 | 2 | 1 | 20 | 1 | 0 | 18 | 2 | 0 |
Change From Baseline in Adenoid/Choana (A/C) Index Grade
Changes in adenoid size were assessed by nasopharyngoscopic examination and were determined using the Adenoid/Choana (A/C) Index. Grades were assigned to intervals of A/C ratio percentages: grade I (0-25%), II (26-50%), III (51-75%) and IV (76-100%). Changes in adenoid size were expressed as the mean difference between grades at baseline and study visit. Positive values indicated a decrease in adenoid size, a 0 value indicated that size remained the same, and negative values indicated an increase in adenoid size. (NCT00552032)
Timeframe: Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)
| Intervention | Score on a Scale (Mean) |
|---|
| Change at Visit 3 (n=65 MFNS, n=63 Placebo) | Change at Visit 4 (n=61 MFNS, n=58 Placebo) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 0.3 | 0.4 |
,| Placebo Nasal Spray | 0.2 | 0.3 |
Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)
The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered & answered by participants' parents. Questionnaire consists of 23 items using a 3-point scale: from 0 (not at all), 2 (sometimes), 4 (a lot). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL. (NCT00552032)
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
| Intervention | Score on a scale (Mean) |
|---|
| Visit 2 (n= 28 MFNS, n=24 Placebo) | Visit 3 (n=28 MFNS, n= 23 Placebo) | Visit 4 (n=28 MFNS, n=22 Placebo) |
|---|
| Mometasone Furoate Nasal Spray (MFNS) | 78.14 | 81.56 | 83.54 |
,| Placebo Nasal Spray | 79.03 | 84.07 | 82.71 |
Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15
Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period. (NCT00552110)
Timeframe: 15 days of treatment
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Combination1 | -3.29 |
| Combination3 | -3.36 |
| Mometasone | -2.97 |
| Oxymetazoline | -2.44 |
| Placebo | -1.90 |
Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score
Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1. (NCT00552110)
Timeframe: from baseline to hour 4 on Day 1
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Combination1 | -0.80 |
| Combination3 | -0.92 |
| Mometasone | -0.63 |
| Oxymetazoline | -1.06 |
| Placebo | -0.57 |
Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
"Peak FEV1 was defined as the peak FEV1 up to 4 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in peak FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate." (NCT00556673)
Timeframe: Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.
| Intervention | Percent of predicted (Least Squares Mean) |
|---|
| Indacaterol/Mometasone | 16.27 |
| Placebo | 6.85 |
| Fluticasone/Salmeterol | 16.49 |
Change From Period Baseline in Trough FEV1/FVC Ratio
The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Trough FEV1/FVC was calculated from measurements taken 24 hours post-dose. Change from baseline in trough FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate. (NCT00556673)
Timeframe: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
| Intervention | ratio (Least Squares Mean) |
|---|
| Indacaterol/Mometasone | 2.50 |
| Placebo | 2.15 |
| Fluticasone/Salmeterol | 2.65 |
Change From Period Baseline in Trough Forced Vital Capacity (FVC)
Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was measured 24 hours post-dose. Change form baseline in trough FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate. (NCT00556673)
Timeframe: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
| Intervention | liters (Least Squares Mean) |
|---|
| Indacaterol/Mometasone | 0.22 |
| Placebo | -0.14 |
| Fluticasone/Salmeterol | 0.17 |
Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
"Trough FEV1 was measured 24 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in trough FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate." (NCT00556673)
Timeframe: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
| Intervention | Percent of predicted (Least Squares Mean) |
|---|
| Indacaterol/Mometasone | 6.95 |
| Placebo | -2.87 |
| Fluticasone/Salmeterol | 9.85 |
Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate. (NCT00556673)
Timeframe: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
| Intervention | liters (Least Squares Mean) |
|---|
| Indacaterol/Mometasone | 0.27 |
| Placebo | -0.12 |
| Fluticasone/Salmeterol | 0.37 |
Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol
(NCT00556673)
Timeframe: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
| Intervention | pg/mL (Mean) |
|---|
| Indacaterol/Mometasone | 289 |
Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate
(NCT00556673)
Timeframe: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, and 12 hours post-dose.
| Intervention | pg*h/mL (Mean) |
|---|
| Indacaterol/Mometasone | 287 |
Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol
(NCT00556673)
Timeframe: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
| Intervention | pg*h/mL (Mean) |
|---|
| Indacaterol/Mometasone | 1331 |
Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate
(NCT00556673)
Timeframe: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
| Intervention | pg*h/mL (Mean) |
|---|
| Indacaterol/Mometasone | 389 |
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Peak FEV1 is defined as the peak FEV1 between 0 and 4 hours post-dose. The change from baseline in peak FEV1 was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate. (NCT00556673)
Timeframe: Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.
| Intervention | liters (Least Squares Mean) |
|---|
| Indacaterol/Mometasone | 0.64 |
| Placebo | 0.26 |
| Fluticasone/Salmeterol | 0.62 |
Change From Period Baseline in Peak FEV1/FVC Ratio
The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Peak FEV1/FVC was calculated from spirometry measurements taken up to 4 hours post-dose. Change from baseline in peak FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate. (NCT00556673)
Timeframe: Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.
| Intervention | ratio (Least Squares Mean) |
|---|
| Indacaterol/Mometasone | 2.86 |
| Placebo | 2.53 |
| Fluticasone/Salmeterol | 2.90 |
Change From Period Baseline in Peak Forced Vital Capacity (FVC)
Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC was measured up to 4 hours post-dose. Change from baseline in peak FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate. (NCT00556673)
Timeframe: Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.
| Intervention | liters (Least Squares Mean) |
|---|
| Indacaterol/Mometasone | 0.47 |
| Placebo | 0.20 |
| Fluticasone/Salmeterol | 0.35 |
Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol
(NCT00556673)
Timeframe: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
| Intervention | hours (Median) |
|---|
| Indacaterol/Mometasone | 0.325 |
Forced Expiratory Volume in 1 Second (FEV1) Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours Post-dose
"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was measured pre-dose and up to 24 hours post-dose. The FEV1 standardized area under the curve (AUC) was analyzed for four time intervals:~Baseline (pre-dose) to 4 hours (hr) post-dosing;~Baseline (pre-dose) to 23 hours, 45 minutes (min) post-dosing;~11 hours, 10 minutes to 12 hours, 30 minutes post-dosing;~11 hours, 10 minutes to 23 hours, 45 minutes post-dosing.~AUC for FEV1 was analyzed using Analysis of Covariance adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect." (NCT00557440)
Timeframe: Pre-dose, 5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.
| Intervention | liters (Least Squares Mean) |
|---|
| Baseline to 4 hours [N=36, 36, 37] | Baseline to 23 hours, 45 minutes [N=36, 36, 37] | 11 hr, 10 min to 12 hr, 30 min [N=36, 35, 34] | 11 hr, 10 min to 23 hr, 45min [N=36, 36, 36] |
|---|
| Fluticasone/Salmeterol | 2.713 | 2.679 | 2.585 | 2.696 |
,| Indacaterol/Mometasone | 2.730 | 2.718 | 2.667 | 2.726 |
,| Placebo | 2.469 | 2.430 | 2.314 | 2.470 |
Forced Vital Capacity (FVC) at Single Time Points
"Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.~FVC was analyzed using ANCOVA adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect." (NCT00557440)
Timeframe: 5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.
| Intervention | liters (Least Squares Mean) |
|---|
| 5 minutes [N= 36, 36, 37] | 30 minutes [N= 36, 36, 36] | 1 hour [N= 36, 36, 36] | 2 hours [N= 36, 36, 36] | 3 hours [N= 36, 36, 36] | 4 hours [N= 36, 36, 35] | 11 hours 10 minutes [N= 36, 35, 34] | 11 hours 45 minutes [N= 36, 35, 32] | 12 hours 30 minutes [N= 36, 35, 32] | 14 hours [N= 36, 35, 32] | 16 hours [N= 36, 35, 31] | 18 hours [N= 35, 36, 33] | 20 hours [N= 35, 36, 34] | 22 hours [N= 35, 36, 34] | 23 hours 10 minutes [N= 35, 36, 35] | 23 hours 45 minutes [N=36, 36, 34] |
|---|
| Fluticasone/Salmeterol | 3.880 | 3.933 | 3.955 | 3.899 | 3.923 | 3.861 | 3.828 | 3.736 | 3.841 | 3.894 | 3.787 | 3.866 | 3.848 | 3.906 | 3.866 | 3.825 |
,| Indacaterol/Mometasone | 3.917 | 3.946 | 3.945 | 4.080 | 3.925 | 3.857 | 3.896 | 3.837 | 3.833 | 3.918 | 3.896 | 3.893 | 3.903 | 3.865 | 3.870 | 3.866 |
,| Placebo | 3.830 | 3.839 | 3.808 | 3.742 | 3.708 | 3.665 | 3.632 | 3.607 | 3.680 | 3.759 | 3.737 | 3.784 | 3.764 | 3.764 | 3.808 | 3.817 |
Forced Expiratory Volume in 1 Second (FEV1) at Single Time Points
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect. (NCT00557440)
Timeframe: 5, 30 minutes, 1, 2, 3, 4 hours, 11 hours 10 minutes, 11 hours 45 minutes, 12 hours 30 minutes, 14, 16, 18, 20, 22 hours, 23 hours 10 minutes, and 23 hours 45 minutes post-dosing.
| Intervention | liters (Least Squares Mean) |
|---|
| 5 minutes [N=36, 36, 37] | 30 minutes [N=36, 36, 36] | 1 hour [N=36, 36, 36] | 2 hours [N=36, 36, 36] | 3 hours [N=36, 36, 36] | 4 hours [N=36, 36, 35] | 11 hours 10 minutes [N=36, 35, 34] | 11 hours 45 minutes [N=36, 35, 32] | 12 hours 30 minutes [N=36, 35, 32] | 14 hours [N=36, 35, 32] | 16 hours [N=36, 35, 31] | 18 hours [N=35, 36, 33] | 20 hours [N=35, 36, 34] | 22 hours [N=35, 36, 34] | 23 hours 10 minutes [N=35, 36, 35] | 23 hours 45 minutes [N=36, 36, 34] | 24 hours post-dose trough [N=36, 36, 35] |
|---|
| Fluticasone/Salmeterol | 2.632 | 2.719 | 2.771 | 2.734 | 2.724 | 2.669 | 2.570 | 2.518 | 2.659 | 2.779 | 2.681 | 2.717 | 2.707 | 2.695 | 2.676 | 2.640 | 2.656 |
,| Indacaterol/Mometasone | 2.713 | 2.754 | 2.760 | 2.754 | 2.728 | 2.705 | 2.685 | 2.628 | 2.667 | 2.766 | 2.720 | 2.729 | 2.725 | 2.674 | 2.696 | 2.686 | 2.689 |
,| Placebo | 2.554 | 2.527 | 2.525 | 2.483 | 2.425 | 2.376 | 2.295 | 2.276 | 2.359 | 2.485 | 2.454 | 2.513 | 2.479 | 2.487 | 2.530 | 2.523 | 2.524 |
Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect. (NCT00557440)
Timeframe: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
| Intervention | liters (Least Squares Mean) |
|---|
| Indacaterol/Mometasone | 0.081 |
| Fluticasone/Salmeterol | 0.049 |
| Placebo | -0.083 |
Time to Peak Forced Expiratory Volume in 1 Second (FEV1)
"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1 during the first 4 hours post-dose.~Time to peak FEV1 is based on log-transformed analysis of variance adjusted for treatment, period, sequence and center, with patient nested within sequence as a random effect. Geometric Mean was obtained by taking anti-logs of the adjusted means from the model and standard error was calculated using the delta method." (NCT00557440)
Timeframe: Up to 4 hours post-dose
| Intervention | minutes (Geometric Mean) |
|---|
| Indacaterol/Mometasone | 87.4 |
| Fluticasone/Salmeterol | 67.7 |
| Placebo | 22.3 |
Participant Average Weekly Rhinoconjunctivitis Quality-of-Life Questionnaire With Standardized Activities (RQLQ(S)) Total Score Over the Entire GPS
The RQLQ(s) has 28 questions and focusses on 7 domains that may be significantly impaired in participants with seasonal allergic rhinoconjunctivitis: sleep impairment, non-nasal symptoms, practical problems, nasal symptoms, eye symptoms, activity limitations, and emotional difficulty. The RQLQ score is the mean of all 28 responses and the individual domain scores are the means of the items in those domains. RQLQ scores range from 0-6, with a higher score indicating more significant impairment. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS
| Intervention | Units on a Scale (Mean) |
|---|
| SCH 697243 | 1.30 |
| Placebo | 1.57 |
Participant Total Combined Symptom (TCS) Score Over the Entire Grass Pollen Season (GPS)
The TCS is the sum of the rhinoconjunctivitis daily symptom score (DSS) and rhinoconjunctivitis daily medication score (DMS) averaged over the entire GPS. The TCS ranged from 0-54, with increasing score indicating a higher level of symptom severity. The DSS is composed of 6 rhinoconjunctivitis symptoms with scores from 0-18, with increasing score indicating increased severity. The DMS is composed of a sum of the scores associated with rescue medication use per day. The range for the DMS was 0-36, with a lower score indicating less use of rescue medication. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS
| Intervention | Units on a Scale (Mean) |
|---|
| SCH 697243 | 5.08 |
| Placebo | 6.39 |
Participant Average Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire GPS
The DMS is composed of a sum of the scores associated with rescue medication use per day. Rescue medications were implemented when a participant had a symptom score >= 4. Rescue medications for allergic rhinoconjunctivitis were to be utilized in a step-wise fashion: loratadine, olopatadine hydrochloride 0.1% opthalmic solution, mometasone, and prednisone, in that sequence. The score for the DMS ranged from 0-36. A lower medication score indicated less impact on symptomology and was suggestive of less use of rescue medication. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS
| Intervention | Units on a Scale (Mean) |
|---|
| SCH 697243 | 1.25 |
| Placebo | 1.70 |
Participant Average Rhinoconjunctivitis Daily Symptom Score (DSS) Over the Entire GPS
The DSS is composed of six rhinoconjunctivitis symptoms which were recorded daily including runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy, and watery eyes, and the symptoms were measured on a scale of 0 (no symptom) to 3 (severe symptoms). A higher score indicated a higher level of symptoms and the total daily score could range from 0 to 18. (NCT00562159)
Timeframe: Start of the GPS to End of the GPS
| Intervention | Units on a Scale (Mean) |
|---|
| SCH 697243 | 3.83 |
| Placebo | 4.69 |
The Change of the Rhinasthma Global Summary Score From Baseline to Endpoint After 28 Days of Treatment.
To explore the efficacy of mometasone furoate nasal spray in comparison with placebo in improving the quality of life of subjects with moderate-severe PER and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). The Rhinasthma is a questionnaire that consists of 30 items and for each of them subjects had to indicate on a Likert scale (1=not at all; 5=very much) the degree of limitation or discomfort caused by each problem. Possible total best score = 150 and possible total worst score = 30. (NCT00599027)
Timeframe: Baseline and 28 days of treatment
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Endpoint after 28 days of treatment |
|---|
| Mometasone Furoate Nasal Spray | 25.3 | -10.3 |
,| Placebo Nasal Spray | 26.7 | 0.4 |
End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population)
The difference in the final MDI dose counter readout and the total number of recorded actuations at the end-of-use. Dose Counter end-of-use agreement was calculated as the sum of the absolute difference between the final dose counter readout and the number of recorded actuations across all participants who used at least 90% of the labeled actuations (excluding participants who used the inhaler beyond the labeled number of actuations) divided by the total number of participants in this population. No participant used more than two inhalers during the treatment period. (NCT00604500)
Timeframe: 4-week Treatment Period
| Intervention | Number of inhalers (Number) |
|---|
| MF/F MDI 100/10 mcg BID (With Dose Counter) | 175 |
Overall Quartile Discrepancy Rate
"Quartile discrepancies refer to the difference between~the participant-recorded number of actuations and the participant-recorded~counter readout at each of the 4 weekly visit intervals [ie, quartiles] to~evaluate whether there was any difference in agreement over the life of~the inhaler. The Quartile Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies per Quartile across all participant who used at least 90% of the labeled actuations divided by the total number of actuations per Quartile in the same population." (NCT00604500)
Timeframe: 4-week Treatment Period
| Intervention | discrepancies per 100 actuations (Number) |
|---|
| MF/F MDI 100/10 mcg BID (With Dose Counter) | 0.13 |
Overall Discrepancy Size
Discrepancy Size refers to the magnitude of the discrepancy between the dose counter readout and the number of recorded actuations (definition of discrepancy). Overall Discrepancy Size was calculated as 100 multiplied by the sum of the absolute values from each Dose Counter Discrepancy Size across all participants who used at least 90% of the labeled actuations divided by the total number of recorded actuations in the same participant population. (NCT00604500)
Timeframe: 4-week Treatment Period
| Intervention | Discrepancy Size Per 100 actuations (Number) |
|---|
| MF/F MDI 100/10 mcg BID (With Dose Counter) | 0.14 |
Overall Discrepancy Rate
Overall discrepancies refer to the difference between the participant-recorded number of actuations and the participant-recorded dose counter readout across the 4-week Treatment Period. The Overall Discrepancy Rate was calculated as 100 multiplied by the total number of discrepancies across all participants who used at least 90% of the labeled actuations divided by the total number of actuations in the same participant population (Completer Population). (NCT00604500)
Timeframe: 4-week Treatment Period
| Intervention | Overall discrepancies per 100 actuations (Number) |
|---|
| MF/F MDI 100/10 mcg BID (With Dose Counter) | 0.13 |
Levels of Plasma Glucose Over Time
At the specified time-points, blood samples were collected for measurement of plasma glucose and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose. (NCT00605306)
Timeframe: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
| Intervention | mmol/L (Mean) |
|---|
| Baseline (N=14, 14) | Day 1, pre-dose (N=14, 14) | Day 1, 0.25 hours post-dose (N=14, 14) | Day 1, 0.5 hours post-dose (N=14, 14) | Day 1, 1 hour post-dose (N=14, 14) | Day 1, 2 hours post-dose (N=14, 14) | Day 1, 4 hours post-dose (N=14, 14) | Day 2, 12 hours post-dose (N=14, 14) | Day 2, 24 hours post-dose (N=14, 14) | Day 14, pre-dose (N=14, 14) | Day 14, 0.25 hours post-dose (N=14, 13) | Day 14, 0.5 hours post-dose (N=14, 13) | Day 14, 1 hour post-dose (N=14, 13) | Day 14, 2 hours post-dose (N=14, 13) | Day 14, 4 hours post-dose (N=14, 13) | End of study (N=14, 13) |
|---|
| Indacaterol Maleate/Mometasone Furoate | 5.079 | 5.057 | 5.007 | 4.950 | 5.036 | 5.057 | 7.064 | 5.221 | 5.293 | 5.129 | 5.136 | 5.157 | 5.136 | 5.093 | 6.929 | 5.257 |
,| Placebo | 5.157 | 5.236 | 5.264 | 5.207 | 5.193 | 5.179 | 6.793 | 5.286 | 5.321 | 5.221 | 4.900 | 4.946 | 4.962 | 4.908 | 7.408 | 5.731 |
Levels of Serum Cortisol Over Time
At the specified time-points, blood samples were collected for measurement of serum cortisol and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose. (NCT00605306)
Timeframe: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4, 11, 12, 13 hours post-dose; 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
| Intervention | mmol/L (Mean) |
|---|
| Baseline (N=14, 14) | Day 1, pre-dose (N=14, 14) | Day 1, 0.25 hours post-dose (N=14, 14) | Day 1, 0.5 hours post-dose (N=14, 14) | Day 1, 1 hour post-dose (N=14, 14) | Day 1, 2 hours post-dose (N=14, 14) | Day 1, 4 hours post-dose (N=14, 14) | Day 2, 11 hours post-dose (N=14, 14) | Day 2, 12 hours post-dose (N=14, 14) | Day 2, 13 hours post-dose (N=14, 14) | Day 2, 24 hours post-dose (N=14, 14) | Day 14, pre-dose (N=14, 14) | Day 14, 0.25 hours post-dose (N=14, 13) | Day 14, 0.5 hours post-dose (N=14, 13) | Day 14, 1 hour post-dose (N=14, 13) | Day 14, 2 hours post-dose (N=14, 13) | Day 14, 4 hours post-dose (N=14, 13) | Day 15, 11 hours post-dose (N=14, 14) | Day 15, 12 hours post-dose (N=14, 13) | Day 15, 13 hours post-dose (N=14, 13) | End of study (N=14, 14) |
|---|
| Indacaterol Maleate/Mometasone Furoate | 466.214 | 159.643 | 153.786 | 130.143 | 99.143 | 65.357 | 55.929 | 362.500 | 289.929 | 335.214 | 136.857 | 126.071 | 111.500 | 99.500 | 82.786 | 62.071 | 48.214 | 242.143 | 255.500 | 324.857 | 495.286 |
,| Placebo | 441.143 | 140.714 | 151.000 | 130.571 | 131.929 | 84.286 | 102.071 | 478.214 | 404.214 | 370.071 | 193.500 | 122.857 | 127.231 | 121.154 | 106.385 | 94.154 | 102.154 | 417.000 | 388.769 | 385.769 | 417.786 |
Levels of Serum Potassium Over Time
At the specified time-points, blood samples were collected for measurement of serum potassium and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose. (NCT00605306)
Timeframe: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post-dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
| Intervention | mmol/L (Mean) |
|---|
| Baseline (N=14, 14) | Day 1, pre-dose (N=14, 14) | Day 1, 0.25 hours post-dose (N=14, 14) | Day 1, 0.5 hours post-dose (N=14, 14) | Day 1, 1 hour post-dose (N=14, 14) | Day 1, 2 hours post-dose (N=14, 14) | Day 1, 4 hours post-dose (N=14, 14) | Day 2, 12 hours post-dose (N=14, 14) | Day 2, 24 hours post-dose (N=14, 14) | Day 14, pre-dose (N=14, 14) | Day 14, 0.25 hours post-dose (N=14, 13) | Day 14, 0.5 hours post-dose (N=14, 13) | Day 14, 1 hour post-dose (N=14, 13) | Day 14, 2 hours post-dose (N=14, 13) | Day 14, 4 hours post-dose (N=14, 13) | End of study (N=14, 14) |
|---|
| Indacaterol Maleate/Mometasone Furoate | 4.271 | 4.264 | 4.293 | 4.150 | 4.143 | 4.157 | 3.979 | 4.436 | 4.293 | 4.150 | 4.064 | 3.986 | 3.986 | 3.986 | 3.800 | 4.364 |
,| Placebo | 4.336 | 4.279 | 4.314 | 4.179 | 4.171 | 4.093 | 3.929 | 4.500 | 4.386 | 4.136 | 4.092 | 4.092 | 4.038 | 4.038 | 3.792 | 4.429 |
Participants With Adverse Events
"An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention.~A serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above." (NCT00605306)
Timeframe: 15 days
| Intervention | participants (Number) |
|---|
| Any adverse event | Serious adverse event | AE resulting in discontinuation |
|---|
| Indacaterol Maleate/Mometasone Furoate | 9 | 0 | 0 |
,| Placebo | 12 | 0 | 1 |
Changes in RQLQ: Non-Nasal/Eye
The RQLQ non-nasal/eye range: 0-6. Higher scores indicate a worse quality of life. (NCT00618332)
Timeframe: Baseline and 2 weeks
| Intervention | units on a scale (Mean) |
|---|
| Mometasone Furoate | -1.11 |
| Placebo | -1.26 |
Changes in RQLQ: Eye
The RQLQ eye range: 0-6. Higher scores indicate a worse quality of life. (NCT00618332)
Timeframe: Baseline and 2 weeks
| Intervention | units on a scale (Mean) |
|---|
| Mometasone Furoate | -1.36 |
| Placebo | -1.34 |
Changes in RQLQ: Emotional
The RQLQ emotional range: 0-6. Higher scores indicate a worse quality of life. (NCT00618332)
Timeframe: Baseline and 2 weeks
| Intervention | units on a scale (Mean) |
|---|
| Mometasone Furoate | -1.05 |
| Placebo | -0.94 |
Changes in RQLQ: Activity
The RQLQ activity range: 0-6. Higher scores indicate a worse quality of life. (NCT00618332)
Timeframe: Baseline and 2 weeks
| Intervention | units on a scale (Mean) |
|---|
| Mometasone Furoate | -1.73 |
| Placebo | -1.55 |
Changes in RQLQ: Nasal
The RQLQ nasal range: 0-6. Higher scores indicate a worse quality of life. (NCT00618332)
Timeframe: Baseline and 2 weeks
| Intervention | units on a scale (Mean) |
|---|
| Mometasone Furoate | -1.54 |
| Placebo | -1.31 |
Global Assessment
"Global Assessment: 3=significantly improved, 2=moderately improved,~1=mildly improved, 0=no change, -1=mildly worse, -2=moderately worse, and -3=significantly worse" (NCT00618332)
Timeframe: at week 2
| Intervention | units on a scale (Mean) |
|---|
| Mometasone Furoate | 1.7 |
| Placebo | 1.4 |
Changes in RQLQ: Sleep
The RQLQ sleep range: 0-6. Higher scores indicate a worse quality of life. (NCT00618332)
Timeframe: Baseline and 2 weeks
| Intervention | units on a scale (Mean) |
|---|
| Mometasone Furoate | -1.42 |
| Placebo | -0.85 |
Changes in RQLQ: Practical
The RQLQ practical range: 0-6. Higher scores indicate a worse quality of life. (NCT00618332)
Timeframe: Baseline and 2 weeks
| Intervention | units on a scale (Mean) |
|---|
| Mometasone Furoate | -1.37 |
| Placebo | -1.48 |
Changes in RQLQ: Overall
The RQLQ is a disease-specific measure of a patient's quality of life. It includes domains that measure nasal and eye symptoms as well as those of activity, sleep, non-nasal/eye symptoms, practical and emotional measures. A scale of 0-6 is used to record the patient responses, with lower scores reflecting a better quality of life. The average score of each domain is calculated as well as an overall domain score reflecting the average of all scores. (NCT00618332)
Timeframe: Baseline and 2 weeks
| Intervention | units on a scale (Mean) |
|---|
| Mometasone Furoate | -1.35 |
| Placebo | -1.25 |
Mean Change From Baseline to Day 15 of Mannitol Challenge
Mannitol challenge (also referred to as PD15) is the provocative dose of mannitol required to produce a 15% reduction in the forced expiratory volume (in liters) in one second (FEV1). (NCT00635882)
Timeframe: Baseline to Day 15
| Intervention | milligrams (Mean) |
|---|
| Baseline | Mean Change from Baseline to Day 15 |
|---|
| MF DPI 200 mcg | 137.6 | 159.4 |
,| MF MDI 200 mcg | 126.0 | 146.2 |
,| MF/F MDI 100/10 mcg | 102.2 | 176.6 |
,| MF/F MDI 200/10 mcg | 48.6 | 153.8 |
,| MF/F MDI 400/10 mcg | 67.9 | 162.9 |
,| Placebo | 159.4 | -63.7 |
Change From Baseline in PM Total Asthma Symptom Score at Days 1-15
Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary. (NCT00635882)
Timeframe: Baseline and Days 1-15
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Mean Change from Baseline to Days 1-15 |
|---|
| MF DPI 200 mcg | 1.6 | -1.1 |
,| MF MDI 200 mcg | 1.6 | -0.7 |
,| MF/F MDI 100/10 mcg | 1.7 | -0.4 |
,| MF/F MDI 200/10 mcg | 1.1 | -0.6 |
,| MF/F MDI 400/10 mcg | 2.1 | -1.4 |
,| Placebo | 1.7 | -0.3 |
Change From Baseline in PM PEF at Days 1-15
(NCT00635882)
Timeframe: Baseline and Days 1-15
| Intervention | liters/minute (Mean) |
|---|
| Baseline | Mean Change from Baseline to Days 1-15 |
|---|
| MF DPI 200 mcg | 484.4 | 20.2 |
,| MF MDI 200 mcg | 472.5 | 28.3 |
,| MF/F MDI 100/10 mcg | 462.0 | 47.7 |
,| MF/F MDI 200/10 mcg | 437.2 | 34.5 |
,| MF/F MDI 400/10 mcg | 486.7 | 66.8 |
,| Placebo | 422.7 | 4.5 |
Change From Baseline in AM Total Asthma Symptom Score at Days 2-15
Twice daily, participants rated the following asthma symptoms as experienced during the time period since the last evaluation: wheezing, difficulty breathing, and cough on a scale of 0 (none) to 3 (severe, very uncomfortable and interfered with most or all of normal daily activities/sleep). The total asthma symptom score ranged from 0 to 9. The results were recorded in the participant's diary. (NCT00635882)
Timeframe: Baseline and Days 2-15
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Mean Change from Baseline to Days 2-15 |
|---|
| MF DPI 200 mcg | 1.5 | -1.2 |
,| MF MDI 200 mcg | 1.1 | -0.5 |
,| MF/F MDI 100/10 mcg | 1.6 | -0.7 |
,| MF/F MDI 200/10 mcg | 1.2 | -0.7 |
,| MF/F MDI 400/10 mcg | 2.2 | -1.5 |
,| Placebo | 1.4 | -0.2 |
Change From Baseline in AM Peak Expiratory Flow (PEF) at Days 2-15
(NCT00635882)
Timeframe: Baseline and Days 2-15
| Intervention | liters/minute (Mean) |
|---|
| Baseline | Mean Change from Baseline to Days 2-15 |
|---|
| MF DPI 200 mcg | 466.3 | 30.3 |
,| MF MDI 200 mcg | 473.3 | 30.8 |
,| MF/F MDI 100/10 mcg | 452.6 | 48.1 |
,| MF/F MDI 200/10 mcg | 421.2 | 46.9 |
,| MF/F MDI 400/10 mcg | 468.7 | 69.8 |
,| Placebo | 413.2 | -9.0 |
Mean Percent Change From Baseline to Day 14 in Sputum Eosinophil Count (Percentage)
(NCT00635882)
Timeframe: Baseline to Day 14
| Intervention | percentage of Sputum Eosinophil Count (Mean) |
|---|
| MF/F MDI 100/10 mcg | 21.1 |
| MF/F MDI 200/10 mcg | -35.5 |
| MF/F MDI 400/10 mcg | -75.4 |
| MF DPI 200 mcg | -55.3 |
| MF MDI 200 mcg | -33.7 |
| Placebo | 71.7 |
Mean Percent Change From Baseline to Day 14 in Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)
(NCT00635882)
Timeframe: Baseline to Day 14
| Intervention | percentage of eNO (Mean) |
|---|
| MF/F MDI 100/10 mcg | -35.3 |
| MF/F MDI 200/10 mcg | -45.4 |
| MF/F MDI 400/10 mcg | -61.4 |
| MF DPI 200 mcg | -51.3 |
| MF MDI 200 mcg | -46.1 |
| Placebo | 0.1 |
Mean Percent Change From Baseline to Day 7 in eNO Ppb
(NCT00635882)
Timeframe: Baseline to Day 7
| Intervention | percentage of eNO (Mean) |
|---|
| MF/F MDI 100/10 mcg | -37.9 |
| MF/F MDI 200/10 mcg | -39.7 |
| MF/F MDI 400/10 mcg | -45.6 |
| MF DPI 200 mcg | -46.0 |
| MF MDI 200 mcg | -37.2 |
| Placebo | 4.8 |
Baseline Exhaled Nitric Oxide (eNO) Parts Per Billion (Ppb)
(NCT00635882)
Timeframe: Baseline
| Intervention | ppb (Mean) |
|---|
| MF/F MDI 100/10 mcg | 54.8 |
| MF/F MDI 200/10 mcg | 70.0 |
| MF/F MDI 400/10 mcg | 77.1 |
| MF DPI 200 mcg | 102.6 |
| MF MDI 200 mcg | 66.2 |
| Placebo | 79.6 |
Percentage of Days With Asthma Control
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma control assessed by average percentage of days with asthma control over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. (NCT00666679)
Timeframe: 2 weeks
| Intervention | Percentage of Days (Least Squares Mean) |
|---|
| Montelukast + Mometasone | 35.13 |
| Placebo + Mometasone | 29.04 |
Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. (NCT00666679)
Timeframe: Baseline and 2 weeks
| Intervention | L (Liter) (Least Squares Mean) |
|---|
| Montelukast + Mometasone | 0.22 |
| Placebo + Mometasone | 0.17 |
Change From Baseline in Nighttime Asthma Symptom Score
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in nighttime asthma symptom score (which could range from 0 [best] to 3 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. (NCT00666679)
Timeframe: Baseline and 2 weeks
| Intervention | Units on a Scale (Least Squares Mean) |
|---|
| Montelukast + Mometasone | -0.28 |
| Placebo + Mometasone | -0.18 |
Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) in Patients Who Met Lung Function Eligibility Criteria Specifically at the Randomization Visit.
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period in patients who met lung function eligibility criteria at randomization; measurements taken at 1 and 2 weeks contributed to average. (NCT00666679)
Timeframe: Baseline and 2 Weeks
| Intervention | L (Liter) (Least Squares Mean) |
|---|
| Montelukast + Mometasone | 0.27 |
| Placebo + Mometasone | 0.19 |
Change From Baseline in Total Daily β-agonist Use
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on as-needed β-agonist use assessed by average change from baseline in total daily β-agonist use over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. (NCT00666679)
Timeframe: Baseline and 2 weeks
| Intervention | Puffs (Least Squares Mean) |
|---|
| Montelukast + Mometasone | -0.87 |
| Placebo + Mometasone | -0.27 |
Change From Baseline in Daytime Asthma Symptom Score
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in daytime asthma symptom score (which could range from 0 [best] to 6 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. (NCT00666679)
Timeframe: Baseline and 2 weeks
| Intervention | Units on a Scale (Least Squares Mean) |
|---|
| Montelukast + Mometasone | -0.39 |
| Placebo + Mometasone | -0.24 |
Change From Baseline in Total Peripheral Blood Eosinophils
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on change from baseline in total peripheral blood eosinophils during the 2 week treatment period. (NCT00666679)
Timeframe: Baseline and 2 weeks
| Intervention | 10^3/microliter (Least Squares Mean) |
|---|
| Montelukast + Mometasone | -0.05 |
| Placebo + Mometasone | 0.02 |
Percentage of Days With Asthma Exacerbations
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on worsening of asthma assessed by percentage of days with asthma exacerbations during the 2 week treatment period. (NCT00666679)
Timeframe: 2 Weeks
| Intervention | Percentage of Days (Least Squares Mean) |
|---|
| Montelukast + Mometasone | 9.71 |
| Placebo + Mometasone | 15.14 |
Number of Items in the Asthma Quality of Life (QOL) Questionnaire and the General QOL Questionnaire That Had a Significant (Positive) Change From Baseline to Endpoint
"Questionnaires consisted of items such as General Health Condition (excellent/very good/good/regular/bad), Difficulty to Breathe (always/almost always/considerable part of time/partially/few amount of time/almost never/never), General Asthma Limitations (completely/a lot/enough to be considered/regular/a few/almost nothing/nothing), etc...~The questionnaires together consisted of 44 questions, each question with categorical variables as response. A Friedman test was performed to determine the significance of change in samples from baseline to endpoint, for each question." (NCT00687531)
Timeframe: Day 1 and Week 12
| Intervention | questions (Number) |
|---|
| Mometasone Furoate | 41 |
Number of Participants Who Adhered to Treatment
The compliance was measured via medication consumption. In the end of the last week of study (Week 12), a review of the remaining study drug in the initial prescribed Twisthaler device was done. A Twisthaler reading of 0 indicates no study drug left and full compliance. (NCT00687531)
Timeframe: Day 1 to Week 12
| Intervention | participants (Number) |
|---|
| Twisthaler reading 0 (zero) | Twisthaler reading above zero | Not specified |
|---|
| Mometasone Furoate | 196 | 29 | 25 |
Forced Expiratory Volume in 1 Second (FEV1)
Spirometry was performed to measure FEV1, which is the amount of air the participant is able to exhale in 1 second. Normal values for FEV1 in healthy people depend on age and gender, but values between 80% and 120% of the normal value is considered good. Increased FEV1 indicates improvement in asthma control. (NCT00687531)
Timeframe: Day 1 and Week 12
| Intervention | Liters (Mean) |
|---|
| Initial (Day 1) | Final (Week 12) |
|---|
| Mometasone Furoate | 2.18 | 2.6 |
Morning (AM) and Evening (PM) Peak Expiratory Flow Rate (PEFR)
Participants were to record their daily AM and PM PEFR values in a diary. PEFR can be measured using a peak flow meter that was given to the participant. Normal readings are based on a person's gender, age, and height. A reading of 80 to 100% of the usual or normal peak flow readings indicate that the asthma is under good control. Increased PEFR indicates improvement in asthma control. (NCT00687531)
Timeframe: Day 1 and Week 12
| Intervention | Liters/minute (Mean) |
|---|
| Initial AM (Day 1) | Initial PM (Day 1) | Final AM (Week 12) | Final PM (Week 12) |
|---|
| Mometasone Furoate | 313.3 | 311.12 | 393.3 | 395.09 |
Change From Baseline on Direct Visual Nasal Exams to 12 Months
Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation (NCT00720382)
Timeframe: Change from baseline to 12 months
| Intervention | Participants (Number) |
|---|
| Epistaxis - Day 1 | Epistaxis - Month 12/ET | Nasal Irritation - Day 1 | Nasal Irritation - Month 12/ET | None | Grade 1A | Grade 1B | Grade 2 | Grade 3 | Grade 4 | Conjunctival injection - Day 1 | Conjunctival injection - Month 12/ET | Erythematous TM - Day 1 | Erythematous TM - Month 12/ET | Mild | Lymphadenophthy-Day 1 | Lymphadenopathy - Month 12/ET | Mucosal Edema - Day 1 | Severe | Mucosal Edema - Month 12/ET | Nasal Discharge - Day 1 | Nasal Discharge - Month 12/ET | Moderate | Mucosal Erythema - Day 1 | Mucosal Erythema - Month 12/ET | Mucosal Bleeding - Day 1 | Mucosal Bleeding - Month 12/ET | Crusting of Mucosa - Day 1 | Crusting of Mucosa - Month 12/ET |
|---|
| Nasonex® | 237 | 229 | 8 | 0 | 0 | 220 | 213 | 7 | 0 | 0 | 237 | 217 | 17 | 3 | 0 | 0 | 0 | 220 | 200 | 17 | 2 | 0 | 0 | 1 | 237 | 164 | 58 | 14 | 1 | 220 | 182 | 31 | 7 | 0 | 236 | 226 | 8 | 1 | 1 | 220 | 206 | 12 | 2 | 0 | 237 | 225 | 12 | 0 | 0 | 220 | 210 | 9 | 1 | 0 | 237 | 42 | 87 | 96 | 12 | 220 | 54 | 94 | 66 | 6 | 237 | 89 | 110 | 33 | 5 | 220 | 90 | 107 | 22 | 1 | 237 | 145 | 67 | 21 | 4 | 220 | 142 | 58 | 20 | 0 | 237 | 224 | 11 | 1 | 1 | 220 | 208 | 11 | 1 | 0 | 237 | 215 | 20 | 1 | 1 | 220 | 197 | 22 | 1 | 0 |
Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older
"A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 12 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.~Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items." (NCT00720382)
Timeframe: change from baseline to 12 months
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| Overall Score Baseline | Month 1 | Month 3 | Month 6 | Month 9 | Month 12/ET |
|---|
| Astepro 0.15% | 2.78 | -0.97 | -1.15 | -1.13 | -1.17 | -0.90 |
,| Nasonex® | 2.75 | -0.97 | -1.27 | -1.29 | -1.31 | -1.11 |
Change From Baseline on Direct Visual Nasal Exams to 12 Months
Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation (NCT00720382)
Timeframe: Change from baseline to 12 months
| Intervention | Participants (Number) |
|---|
| Epistaxis - Day 1 | Epistaxis - Month 12/ET | None | Nasal Irritation - Day 1 | Grade 3 | Grade 4 | Nasal Irritation - Month 12/ET | Grade 1A | Grade 1B | Grade 2 | Conjunctival injection - Day 1 | Mild | Conjunctival injection - Month 12/ET | Erythematous TM - Day 1 | Erythematous TM - Month 12/ET | Lymphadenophthy-Day 1 | Lymphadenopathy - Month 12/ET | Mucosal Edema - Day 1 | Mucosal Edema - Month 12/ET | Moderate | Nasal Discharge - Day 1 | Nasal Discharge - Month 12/ET | Mucosal Erythema - Day 1 | Mucosal Erythema - Month 12/ET | Severe | Mucosal Bleeding - Day 1 | Mucosal Bleeding - Month 12/ET | Crusting of Mucosa - Day 1 | Crusting of Mucosa - Month 12/ET |
|---|
| Astepro 0.15% | 466 | 456 | 10 | 0 | 0 | 402 | 387 | 15 | 0 | 0 | 466 | 425 | 37 | 2 | 2 | 0 | 0 | 402 | 374 | 22 | 4 | 2 | 0 | 0 | 466 | 340 | 100 | 24 | 2 | 402 | 336 | 56 | 8 | 2 | 466 | 443 | 21 | 2 | 0 | 402 | 392 | 9 | 1 | 0 | 465 | 433 | 30 | 2 | 0 | 402 | 388 | 13 | 1 | 0 | 466 | 92 | 162 | 181 | 31 | 402 | 101 | 157 | 129 | 15 | 466 | 178 | 202 | 78 | 8 | 402 | 182 | 163 | 53 | 4 | 466 | 258 | 153 | 54 | 1 | 402 | 254 | 114 | 31 | 3 | 466 | 451 | 15 | 0 | 0 | 402 | 384 | 17 | 1 | 0 | 466 | 412 | 46 | 8 | 0 | 402 | 373 | 20 | 9 | 0 |
Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug. (NCT00728416)
Timeframe: 15 days of treatment
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| Mometasone Furoate Nasal Spray | -0.71 |
| Placebo Nasal Spray | -0.40 |
Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug. (NCT00728416)
Timeframe: 15 days of treatment
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| Mometasone Furoate Nasal Spray | -3.00 |
| Placebo Nasal Spray | -1.73 |
The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours [reflective]) (NCT00732381)
Timeframe: 15 days of treatment
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| Mometasone Furoate Nasal Spray | -0.64 |
| Placebo Nasal Spray | -0.49 |
The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective]) (NCT00732381)
Timeframe: 15 days of treatment
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| Mometasone Furoate Nasal Spray | -2.68 |
| Placebo Nasal Spray | -1.85 |
The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. (NCT00733005)
Timeframe: 15 days of treatment
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| Mometasone Furoate Nasal Spray | -2.61 |
| Placebo Nasal Spray | -2.06 |
The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]) (NCT00733005)
Timeframe: 15 days of treatment
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| Mometasone Furoate Nasal Spray | -0.68 |
| Placebo Nasal Spray | -0.57 |
The Standardized Forced Expiratory Volume in 1 Second (FEV1) Using Area Under the Curve (AUC) From 0 to 12 Hours (0-12h) Post-dose by Treatment
For FEV1 AUC(0-12h) the trapezoidal rule was applied using planned time measurements to calculate the AUC up to and including the last measurement recorded before intake of rescue medication. The AUC was standardized by dividing by the length of time for which measurements of FEV1 were included in the calculation of the AUC thus adjusting for subjects who were unable to complete the measurements during the 12-hour observation period and without inhaling rescue medication. The unit of the AUC was in L, being a weighted average of the acceptable FEV1 measurements recorded over 12 hours post dose (NCT00746330)
Timeframe: From 0 to 12 Hours (0-12h) post-dose, after each treatment administered (approximately 1 treatment a week for 4 weeks of treatment).
| Intervention | liters (Least Squares Mean) |
|---|
| MFF10 | 1.77 |
| F12M | 1.77 |
| F12D | 1.80 |
| Placebo | 1.71 |
Serial FEV1 Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect
All efficacy evaluations were based on spirometry assessments of lung function. FEV1 is the maximum amount of air expired in one second. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the (ATS / ERS) standards. (NCT00746330)
Timeframe: 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose
| Intervention | liters (Least Squares Mean) |
|---|
| 5 minutes | 30 minutes | 1 hour (N=32, 31, 29, 31) | 2 hours | 4 hours | 8 hours | 12 hours |
|---|
| F12D | 1.77 | 1.82 | 1.86 | 1.85 | 1.84 | 1.79 | 1.76 |
,| F12M | 1.77 | 1.80 | 1.80 | 1.79 | 1.79 | 1.75 | 1.71 |
,| MFF10 | 1.74 | 1.79 | 1.81 | 1.81 | 1.81 | 1.76 | 1.72 |
,| Placebo | 1.68 | 1.69 | 1.72 | 1.73 | 1.72 | 1.70 | 1.66 |
Serial Forced Vital Capacity (FVC) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect
All efficacy evaluations were based on spirometry assessments of lung function. FVC is the volume (liters) of air that can forcibly be blown out after full inspiration. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the ATS / ERS standards. (NCT00746330)
Timeframe: 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose
| Intervention | liters (Least Squares Mean) |
|---|
| 5 minutes | 30 minutes | 1 hour (N=32, 31, 29, 31) | 2 hours | 4 hours | 8 hours | 12 hours |
|---|
| F12D | 2.09 | 2.11 | 2.15 | 2.14 | 2.12 | 2.10 | 2.09 |
,| F12M | 2.09 | 2.11 | 2.09 | 2.08 | 2.08 | 2.09 | 2.05 |
,| MFF10 | 2.09 | 2.12 | 2.14 | 2.11 | 2.12 | 2.09 | 2.07 |
,| Placebo | 2.08 | 2.08 | 2.10 | 2.11 | 2.11 | 2.09 | 2.06 |
Serial Peak Expiratory Flow Rate (PEF) Measurement (i.e. at 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose) Following Inhalation of a Single Dose of Study Medication to Evaluate the Onset and Duration of the Bronchodilatory Effect
All efficacy evaluations were based on spirometry assessments of lung function. PEF is the greatest airflow rate achieved during forced exhalation with lungs fully inflated. At Visits 2, 3, 4 and 5, spirometry assessments were performed in the clinic at predose and again at 5 and 30 minutes and 1, 2, 4, 8 and 12 hours post-dose within ± 5 minutes of the scheduled time for the time points up to and including 60 minutes post-dose and then within ± 10 minutes for all subsequent time points. Spirometry equipment and performance of spirometric testing were in accordance with the ATS/ERS standards (NCT00746330)
Timeframe: 5, 30 Minutes and 1, 2, 4, 8 and 12 Hours Post-dose
| Intervention | liters (Least Squares Mean) |
|---|
| 5 minutes | 30 minutes | 1 hour (N=32, 31, 29, 31) | 2 hours | 4 hours | 8 hours | 12 hours |
|---|
| F12D | 250.05 | 257.81 | 262.95 | 267.91 | 265.20 | 262.61 | 259.71 |
,| F12M | 248.17 | 253.37 | 257.08 | 259.28 | 258.92 | 255.27 | 250.71 |
,| MFF10 | 246.65 | 255.69 | 261.18 | 261.45 | 264.68 | 257.96 | 255.48 |
,| Placebo | 237.85 | 243.59 | 248.24 | 248.88 | 249.07 | 248.47 | 244.13 |
Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks
The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points. (NCT00783224)
Timeframe: Baseline to 2 weeks of treatment
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| Baseline | Two Weeks |
|---|
| Fluticasone Propionate (FP) | 8.29 | 3.69 |
,| Fluticasone Propionate Placebo (PLAFP) | 8.41 | 1.74 |
,| Mometasone Furoate (MF) | 8.27 | 3.90 |
,| Mometasone Furoate Placebo (PLAMF) | 7.84 | 1.63 |
Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit
"The Asthma Control Questionnaire score ranges from 0 (good control of asthma) to 6 (poor control of asthma). A negative change in score indicates improvement in asthma control.~Repeated measures of analysis of covariance model: change from baseline in ACQ score = treatment + visit + treatment*visit interaction + baseline ACQ score + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient." (NCT00941798)
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months)
| Intervention | units on a scale (Least Squares Mean) |
|---|
| QMF149 Twisthaler® 500/400 | -0.55 |
| Mometasone Twisthaler® | -0.32 |
Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was measured 15 minutes before dosing; measurements within 6 hours of rescue medication use were set to missing. Repeated measures of analysis of covariance model: change from baseline to trough FEV1 = treatment + visit + treatment*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient. (NCT00941798)
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months)
| Intervention | liters (Least Squares Mean) |
|---|
| QMF149 Twisthaler® 500/400 | 0.06 |
| Mometasone Twisthaler® | -0.07 |
Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.
The number of patients with at least one serious asthma exacerbation over the course of the study. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death. (NCT00941798)
Timeframe: up to 21 months
| Intervention | participants (Number) |
|---|
| QMF149 Twisthaler® 500/400 | 2 |
| Mometasone Twisthaler® | 6 |
Number of Patients With at Least One Asthma Worsening Post-baseline
The criterion for asthma worsening were: decrease in peak expiratory flow (PEF) >= 20% from mean baseline on >= 3 consecutive days, nighttime symptom score >= 2 on >= 2 consecutive nights, decrease in forced expiration volume in 1 second (FEV1) >=20% from baseline at evening visits, daytime symptom score of 3 or 4 on >= 2 consecutive days, requiring an urgent unscheduled visit for medical care, 24 hour rescue medication use >= 8 puffs on >= 2 consecutive days, and any other clinically important symptoms (pre-specified MedDRA preferred terms). (NCT00941798)
Timeframe: Up to 21 months
| Intervention | participants (Number) |
|---|
| QMF149 Twisthaler® 500/400 | 533 |
| Mometasone Twisthaler® | 637 |
Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids
Number of patients requiring treatment with systemic corticosteroids (oral or parenteral) over the course of the study (up to 21 months). (NCT00941798)
Timeframe: Up to 21 months
| Intervention | participants (Number) |
|---|
| QMF149 Twisthaler® 500/400 | 124 |
| Mometasone Twisthaler® | 171 |
Time to First Serious Asthma Exacerbation
Defined as the number of days from start of treatment up to the first date when an asthma exacerbation becomes serious. A serious asthma exacerbation was one that resulted in hospitalization, intubation or death. (NCT00941798)
Timeframe: Up to 21 months
| Intervention | months (Median) |
|---|
| QMF149 Twisthaler® 500/400 | 13.3 |
| Mometasone Twisthaler® | 13.4 |
Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime
"Total asthma symptom score = morning symptoms (0, 1) + daytime score (0-4) + nighttime score (0-4). The range is from 0 to 9. A lower number indicates improvement. Baseline = the last 14 days prior to start of treatment.~Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient." (NCT00941798)
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months)
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Total (n = 708, 733) | Daytime (n = 731, 749) | Nighttime (n = 730, 746) |
|---|
| Mometasone Twisthaler® | -0.94 | -0.39 | -0.36 |
,| QMF149 Twisthaler® 500/400 | -1.22 | -0.50 | -0.46 |
Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit
Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FEV1 data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FEV1 = treatment + visit + treatment*visit interaction + baseline FEV1 + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient. (NCT00941798)
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose
| Intervention | liters (Least Squares Mean) |
|---|
| 5 minutes post-dose (n = 578, 607) | 30 minutes post-dose (n = 576, 605) | 1 hour post-dose (n = 575, 602) | 2 hours post-dose (n = 568, 601) |
|---|
| Mometasone Twisthaler® | -0.04 | -0.05 | -0.06 | -0.05 |
,| QMF149 Twisthaler® 500/400 | 0.09 | 0.12 | 0.13 | 0.14 |
Change From Baseline in Forced Vital Capacity (FVC) at Final Visit
Spirometry was conducted according to internationally accepted standards. Change from baseline at final visit. FVC data taken within 6 hours of rescue medication was excluded from the analysis. Repeated measures of analysis of covariance model: change from baseline to final visit FVC = treatment + visit + treatment*visit interaction + baseline FVC + region + asthma related hospitalization in the last 12 months + asthma worsening in the last 12 months + African American patient. (NCT00941798)
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose
| Intervention | liter (Least Squares Mean) |
|---|
| 5 minutes post-dose (n = 578, 607) | 30 minutes post-dose (n = 576, 605) | 1 hour post-dose (n = 575, 602) | 2 hours post-dose (n = 568, 601) |
|---|
| Mometasone Twisthaler® | -0.11 | -0.13 | -0.13 | -0.13 |
,| QMF149 Twisthaler® 500/400 | -0.03 | -0.03 | -0.01 | -0.02 |
Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime
Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient. (NCT00941798)
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months)
| Intervention | percentage of days (Least Squares Mean) |
|---|
| Morning (n = 730, 746) | Daytime (n = 731, 749) | Nighttime (n = 730, 746) |
|---|
| Mometasone Twisthaler® | 18.4 | 19.5 | 17.3 |
,| QMF149 Twisthaler® 500/400 | 22.3 | 27.1 | 23.6 |
Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period
"PEF was performed every morning and evening prior to study medication use except evenings on the day of clinic visits.~Baseline is average over the last 14 days prior to start of treatment. Analysis of covariance model: change from baseline in PEF = treatment + baseline PEF + region + history of asthma related hospitalization in the past 12 months + history of asthma worsening in the past 12 months + African American patient." (NCT00941798)
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months)
| Intervention | liters per second (Least Squares Mean) |
|---|
| Morning PEF (n = 730, 746) | Evening PEF (n = 731, 748) |
|---|
| Mometasone Twisthaler® | 0.00 | -0.15 |
,| QMF149 Twisthaler® 500/400 | 0.43 | 0.27 |
Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime
24 hours consists of both 12 hour daytime and 12 hour nighttime. Baseline = the last 14 days prior to start of treatment. Analysis of covariance model: Change from baseline = treatment + baseline value + region + history of asthma related hospitalization in past 12 months + history of asthma worsening in past 12 months + African American patient. (NCT00941798)
Timeframe: Baseline to the end of treatment (varying durations, up to 21 months)
| Intervention | percentage of days (Least Squares Mean) |
|---|
| 24 hours (n = 669, 696) | Daytime (n = 692, 711) | Nighttime (n = 691, 708) |
|---|
| Mometasone Twisthaler® | 17.9 | 13.8 | 14.5 |
,| QMF149 Twisthaler® 500/400 | 29.1 | 23.6 | 24.6 |
Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population)
"Patients were required to record a 12 hour reflective score twice a day approximately 12 hours apart. For the rTNSS patients were asked to look back or reflect on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.~Mean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.~Mean change from baseline was calculated as mean baseline rTNSS - mean post-randomization rTNSS. A positive change from baseline in rTNSS is considered a favorable outcome." (NCT01038427)
Timeframe: Baseline, 14 days
| Intervention | score on scale (Mean) |
|---|
| Test | 1.981 |
| Reference | 1.817 |
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Equivalence: Per-Protocol Population)
"Patients were required to record an instantaneous score twice a day approximately 12 hours apart. For the iTNSS patients were asked to evaluate how I feel now regarding their severity of nasal symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean iTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.~Mean baseline iTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.~Mean change from baseline was calculated as mean baseline iTNSS - mean post-randomization iTNSS. A positive change from baseline in iTNSS is considered a favorable outcome." (NCT01038427)
Timeframe: Baseline, 14 days
| Intervention | score on scale (Mean) |
|---|
| Test | 1.900 |
| Reference | 1.656 |
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Superiority: Intent-to-Treat Population)
"Patients were required to record an instantaneous score twice a day approximately 12 hours apart. For the iTNSS patients were asked to evaluate how I feel now regarding their severity of nasal symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean iTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.~Mean baseline iTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.~Mean change from baseline was calculated as mean baseline iTNSS - mean post-randomization iTNSS. A positive change from baseline in iTNSS is considered a favorable outcome." (NCT01038427)
Timeframe: Baseline, 14 days
| Intervention | score on scale (Mean) |
|---|
| Test | 1.932 |
| Reference | 1.630 |
| Placebo | 0.905 |
Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Superiority: Intent-to-Treat Population)
"Patients were required to record a 12 hour reflective score twice a day approximately 12 hours apart. For the rTNSS patients were asked to look back or reflect on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms.~Mean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period.~Mean change from baseline was calculated as mean baseline rTNSS - mean post-randomization rTNSS. A positive change from baseline in rTNSS is considered a favorable outcome." (NCT01038427)
Timeframe: Baseline, 14 days
| Intervention | score on scale (Mean) |
|---|
| Test | 2.008 |
| Reference | 1.794 |
| Placebo | 1.034 |
Allergen-induced Concentrations of Sputum LTC4
Concentrations of LTC4 in sputum at 2 hours post-allergen challenge (NCT01061333)
Timeframe: 2 hours post allergen challenge
| Intervention | pg/mL (Geometric Mean) |
|---|
| Placebo | 13.63 |
| Nedocromil | 14.02 |
| Montelukast | 13.76 |
| Mometasone | 12.14 |
Allergen-induced Concentrations of Sputum LTD4
Concentrations of LTD4 in sputum at 2 hours post-allergen challenge (NCT01061333)
Timeframe: 2 hours post allergen challenge
| Intervention | pg/mL (Geometric Mean) |
|---|
| Placebo | 17.48 |
| Nedocromil | 18.04 |
| Montelukast | 18.52 |
| Mometasone | 17.37 |
Allergen-induced Concentrations of Sputum LTE4
Concentrations of LTE4 in sputum at 2 hours post-allergen challenge (NCT01061333)
Timeframe: 2 hours post allergen challenge
| Intervention | pg/mL (Geometric Mean) |
|---|
| Placebo | 115.5 |
| Nedocromil | 149.8 |
| Montelukast | 181.3 |
| Mometasone | 140.3 |
Change in Forced Expiratory Volume in 1 Second (FEV1)
Maximal percent drop in FEV1 at 20 minutes post allergen challenge (NCT01061333)
Timeframe: Pre-allergen challenge and 20 minutes after allergen challenge
| Intervention | Percentage drop in FEV1 (Least Squares Mean) |
|---|
| Placebo | -24.66 |
| Nedocromil | -8.44 |
| Montelukast | -9.15 |
| Mometasone | -16.17 |
Change in Plasma 9P at 20 Minutes
Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge (NCT01061333)
Timeframe: Pre-allergen challenge and 20 minutes post allergen challenge
| Intervention | Fold change over baseline (Geometric Mean) |
|---|
| Placebo | 1.22 |
| Nedocromil | 0.72 |
| Montelukast | 0.72 |
| Mometasone | 1.06 |
Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes
Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge (NCT01061333)
Timeframe: Pre-allergen challenge and 5 minutes post allergen challenge
| Intervention | Fold change over baseline (Geometric Mean) |
|---|
| Placebo | 0.77 |
| Nedocromil | 0.97 |
| Montelukast | 1.08 |
| Mometasone | 1.00 |
Allergen-induced Changes in Urinary 9P
Fold change over baseline in Urinary 9P at 2 hours post allergen challenge (NCT01061333)
Timeframe: Baseline and 2 hours post allergen challenge
| Intervention | Fold change over baseline (Geometric Mean) |
|---|
| Placebo | 1.54 |
| Nedocromil | 1.39 |
| Montelukast | 1.45 |
| Mometasone | 1.40 |
Allergen-induced Changes in Urinary Leukotriene (LT) E4
Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge (NCT01061333)
Timeframe: Baseline and 2 hours post allergen challenge
| Intervention | Fold change over baseline (Geometric Mean) |
|---|
| Placebo | 1.77 |
| Nedocromil | 1.19 |
| Montelukast | 1.40 |
| Mometasone | 1.62 |
Degree of Posterior Choana Obstruction at Baseline and Week 12
The degree of obstruction of the posterior choana was assessed by endoscopy. Endoscopy grading consisted of Grade I (minimum), Grade II and Grade III (maximum). Grade I was defined as <50% obstruction, Grade II was defined as 50-75% obstruction, and Grade III was defined as >75% obstruction. (NCT01098071)
Timeframe: Baseline and Week 12
| Intervention | Percent obstruction (Mean) |
|---|
| Baseline score | Score at Week 12 |
|---|
| Mometasone Furoate Nasal Spray | 85 | 61 |
Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy
(NCT01098071)
Timeframe: Baseline to 12 weeks
| Intervention | Participants (Number) |
|---|
| Mometasone Furoate Nasal Spray | 2 |
Severity of Eye Symptoms at Baseline and Week 12
Eye symptoms are a symptom of allergic rhinitis. Eye symptoms were assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]). (NCT01098071)
Timeframe: Baseline and Week 12
| Intervention | Score on a scale (Mean) |
|---|
| Baseline score | Score at Week 12 |
|---|
| Mometasone Furoate Nasal Spray | 0.68 | 0.16 |
Severity of Sneezing at Baseline and Week 12
Sneezing is a symptom of allergic rhinitis. Sneezing was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]). (NCT01098071)
Timeframe: Baseline and Week 12
| Intervention | Score on a scale (Mean) |
|---|
| Baseline score | Score at Week 12 |
|---|
| Mometasone Furoate Nasal Spray | 0.89 | 0.37 |
Severity of Rhinorrhea at Baseline and Week 12
Rhinorrhea is a symptom of allergic rhinitis. Rhinorrhea was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]). (NCT01098071)
Timeframe: Baseline and Week 12
| Intervention | Score on a scale (Mean) |
|---|
| Baseline score | Score at Week 12 |
|---|
| Mometasone Furoate Nasal Spray | 0.95 | 0.37 |
Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score
Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms [best score] and 5 = worst symptoms [worst score]). (NCT01098071)
Timeframe: Baseline and Week 12
| Intervention | Score on a scale (Mean) |
|---|
| Baseline score | Score at Week 12 |
|---|
| Mometasone Furoate Nasal Spray | 3.89 | 1.26 |
Severity of Nasal Itching at Baseline and Week 12
Nasal itching is a symptom of allergic rhinitis. Nasal itching was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]). (NCT01098071)
Timeframe: Baseline and Week 12
| Intervention | Score on a scale (Mean) |
|---|
| Baseline score | Score at Week 12 |
|---|
| Mometasone Furoate Nasal Spray | 0.74 | 0.37 |
Severity of Nasal Congestion at Baseline and Week 12
Nasal congestion is a symptom of allergic rhinitis. Nasal congestion was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]). (NCT01098071)
Timeframe: Baseline and Week 12
| Intervention | Score on a scale (Mean) |
|---|
| Baseline score | Score at Week 12 |
|---|
| Mometasone Furoate Nasal Spray | 0.79 | 0.32 |
Childhood Asthma Control Test
Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control (NCT01118312)
Timeframe: 24 weeks
| Intervention | units on a scale (Mean) |
|---|
| Nasal Steroid | 4.15 |
| Placebo | 4.53 |
Asthma Control Test (ACT)
Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control (NCT01118312)
Timeframe: 24 weeks
| Intervention | units on a scale (Mean) |
|---|
| Nasal Steroid | 2.95 |
| Placebo | 2.44 |
Change From Baseline in the Total Nasal Symptom Score at 1 Week
Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. (NCT01135134)
Timeframe: Baseline and 1 week
| Intervention | score on a scale (Least Squares Mean) |
|---|
| MFNS | -2.4686 |
| Placebo | -1.1651 |
Change From Baseline in the Total Nasal Symptom Score at 2 Weeks
Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. (NCT01135134)
Timeframe: Baseline and 2 weeks (or discontinuation)
| Intervention | score on a scale (Least Squares Mean) |
|---|
| MFNS | -3.9850 |
| Placebo | -1.9081 |
Change From Baseline in the Total Nasal Symptom Score
Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms. (NCT01165424)
Timeframe: Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation)
| Intervention | units on a scale (Mean) |
|---|
| Change at Week 2 | Change at Week 4 | Change at Week 8 | Change at Week 12 | Change at Week 24 |
|---|
| MFNS | -3.1 | -3.9 | -4.4 | -4.5 | -4.8 |
Number of Participants With Adverse Events and Adverse Drug Reactions
(NCT01165424)
Timeframe: Baseline to Week 24
| Intervention | participants (Number) |
|---|
| Number with Adverse Events | Number with Adverse Drug Reactions |
|---|
| MFNS | 76 | 18 |
Albuterol Induced Percent Change in Qaw
Qaw will be measured before and 15 min after albuterol inhalation (NCT01210170)
Timeframe: change in Qaw 15 minutes after albuterol inhalation
| Intervention | percent change in Qaw (Mean) |
|---|
| 400 mcg Mometasone 30 Minutes Before Albuterol | 18 |
| Mometasone Placebo 30 Minutes Before Albuterol | 0 |
| 400 mcg Mometasone and Albuterol Simultaneously | 30 |
| Mometasone Placebo and Albuterol Simultaneously | -2 |
| 400 mcg Mometasone 60 Minutes Before Albuterol | NA |
| Mometasone Placebo 60 Minutes Before Albuterol | NA |
| 200 mcg Mometasone and Albuterol Simultaneously | NA |
| 200 mcg Mometasone 60 Minutes Before Albuterol | NA |
| 200 mcg Mometasone 30 Minutes Before Albuterol | NA |
Albuterol-induced Change in FEV1
FEV1 will be measured before and after inhalation of 180 mcg albuterol. (NCT01210170)
Timeframe: 15 minutes after albuterol inhalation
| Intervention | liters (Mean) |
|---|
| All Participants Received 400 mcg Mometasone-30 Min | 0.27 |
| All Participants Received Placebo 30 Minutes Before Albuterol | 0.18 |
| All Participants Received 400 mcg Mometasone Simultaneous | 0.32 |
| All Participants Received Placebo Simultaneously With Albutero | 0.20 |
| All Participants Received 200 mcg Mometasone-30 Min | 0.23 |
| All Participants Received 400 mcg -60 Min | NA |
| All Participants Received Placebo -60 Min | NA |
| All Participants Received 200 mcg Mometasone Simultaneous | NA |
| All Participants Received 200 mcg -60 Min | NA |
Area Under the Curve From 0-12 Hours (AUC[0-12h]) of the Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) After a Single Dose of MF/F MDI With Spacer Compared to Placebo MDI Combined With or Without Spacer
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule. (NCT01258803)
Timeframe: Up to 12 hours postdose
| Intervention | Liters (Least Squares Mean) |
|---|
| MF/F MDI With Spacer | 0.115 |
| Placebo MDI With or Without Spacer | -0.009 |
AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of F DPI Compared to Placebo MDI Combined With or Without Spacer
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule. (NCT01258803)
Timeframe: Up to 12 hours postdose
| Intervention | Liters (Least Squares Mean) |
|---|
| F DPI | 0.097 |
| Placebo MDI With or Without Spacer | -0.009 |
AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F With Spacer Compared to F DPI
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule. (NCT01258803)
Timeframe: Up to 12 hours postdose
| Intervention | Liters (Least Squares Mean) |
|---|
| MF/F MDI With Spacer | 0.115 |
| F DPI | 0.097 |
AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F Without Spacer Compared to F DPI
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule. (NCT01258803)
Timeframe: Up to 12 hours postdose
| Intervention | Liters (Least Squares Mean) |
|---|
| MF/F MDI Without Spacer | 0.093 |
| F DPI | 0.097 |
AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose MF/F MDI Without Spacer Compared to Placebo MDI Combined With or Without Spacer
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule. (NCT01258803)
Timeframe: Up to 12 hours postdose
| Intervention | Liters (Least Squares Mean) |
|---|
| MF/F MDI Without Spacer | 0.093 |
| Placebo MDI With or Without Spacer | -0.009 |
AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer Compared to MF/F MDI Without Spacer
The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule. (NCT01258803)
Timeframe: Up to 12 hours postdose
| Intervention | Liters (Least Squares Mean) |
|---|
| MF/F MDI With Spacer | 0.115 |
| MF/F MDI Without Spacer | 0.093 |
Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
Baseline was defined as the average of 2 predose measurements (taken 30 minutes and immediately before dosing). (NCT01258803)
Timeframe: Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose
| Intervention | Liters (Least Squares Mean) |
|---|
| Baseline (n=79, 79, 79, 79) | 5 minutes postdose (n=79, 79, 79, 79) | 30 minutes postdose (n=79, 79, 79, 79) | 1 hour postdose (n=79, 79, 79, 79) | 2 hours postdose (n=79, 79, 79, 79) | 4 hours postdose (n=79, 79, 79, 79) | 8 hours postdose (n=79, 79, 79, 79) | 12 hours postdose (n=78, 79, 78, 79) |
|---|
| F DPI | 1.570 | 0.105 | 0.117 | 0.136 | 0.135 | 0.118 | 0.087 | 0.059 |
,| MF/F MDI With Spacer | 1.554 | 0.111 | 0.131 | 0.159 | 0.136 | 0.136 | 0.108 | 0.092 |
,| MF/F MDI Without Spacer | 1.563 | 0.068 | 0.099 | 0.131 | 0.126 | 0.115 | 0.093 | 0.046 |
,| Placebo MDI With or Without Spacer | 1.547 | -0.001 | 0.006 | 0.007 | 0.019 | 0.005 | -0.012 | -0.033 |
Change From Baseline in Forced Vital Capacity (FVC) After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose
Baseline was defined as the average of 2 predose FVC measurements (taken 30 minutes and immediately before dosing). (NCT01258803)
Timeframe: Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose
| Intervention | Liters (Least Squares Mean) |
|---|
| Baseline (n=79, 79, 79, 79) | 5 minutes postdose (n=79, 79, 79, 79) | 30 minutes postdose (n=79, 79, 79, 79) | 1 hour postdose (n=79, 79, 79, 79) | 2 hours postdose (n=79, 79, 79, 79) | 4 hours postdose (n=79, 79, 79, 79) | 8 hours postdose (n=79, 79, 79, 79) | 12 hours postdose (n=78, 79, 78, 79) |
|---|
| F DPI | 1.928 | 0.032 | 0.017 | 0.022 | 0.047 | 0.008 | -0.013 | -0.014 |
,| MF/F MDI With Spacer | 1.914 | 0.028 | 0.037 | 0.048 | 0.023 | 0.031 | -0.001 | -0.001 |
,| MF/F MDI Without Spacer | 1.931 | 0.005 | 0.020 | 0.027 | 0.026 | 0.018 | 0.007 | -0.022 |
,| Placebo MDI With or Without Spacer | 1.913 | 0.018 | 0.009 | -0.003 | 0.015 | -0.006 | -0.006 | -0.012 |
Discriminant Validity of Treatment Satisfaction Subscales Statistical Analyses Based on Baseline Reflective Total Nasal Symptom Score (rTNSS) Categories (Low, Medium, High)
Discriminant validity tests whether the subscales differentiate among groups of respondents that differ on a pre-specified criterion, baseline rTNSS. Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 - 7.17; n = 62), Medium Symptoms (7.25 - 9.25; n = 61), or High Symptoms (9.33 - 12.00; n = 62). Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. Contrasts were tested between the Low and Medium Symptoms and the High and Low Symptom categories. Reflective TNSS group served as the independent variable and the nine treatment satisfaction subscales were evaluated as dependent variables by analysis of variance models. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction). (NCT01287364)
Timeframe: Day 1 (Pre-treatment) through Day 7 Treatment Period 1
| Intervention | scores on a scale (Mean) |
|---|
| Interference | Regimen Adaptation | Role Limitation | Regimen Difficulty | Sensory Impact | Hassle | Burden | Regimen Management | Perceived Relief | Overall Satisfaction |
|---|
| High Symptoms | 59.018 | 53.455 | 73.269 | 71.676 | 53.742 | 40.726 | 60.534 | 72.192 | 50.054 | 59.407 |
,| Low Symptoms | 78.726 | 60.764 | 87.141 | 85.940 | 67.934 | 63.361 | 77.818 | 80.949 | 56.066 | 73.189 |
,| Medium Symptoms | 70.931 | 59.491 | 83.528 | 78.890 | 61.452 | 49.839 | 76.109 | 81.771 | 55.457 | 68.607 |
Principal Components Analysis (Treatment Process, Treatment Outcomes) Factor Loadings for Treatment Preference Scales
"Principal components analysis was conducted with varimax rotation that revealed two factors. These two factors are the principal components of the preference scale: Treatment Process and Treatment Outcomes. Loadings represent the degree each of the variables correlates with each of the factors. The loadings range from -1 to 1. An inspection of the factor loadings, reveals the extent to which each of the variables contributes to the meaning of each of the factors. High loading number provide meaning and interpretation of factors." (NCT01287364)
Timeframe: Day 1 (Pre-treatment) through Day 29
| Intervention | factor loadings (Number) |
|---|
| for convenience | for ease of use | for use in public | for taste | fewer problems with medicaton running out nose | for number of sprays per dose | for flexibility in daily activities | for smell | fewer problems w/ medication dripping down throat | for longer relief | for symptom relief | for faster relief | if both were the same price | for better feeling about your appearance | for fewer problems with irritation to your nose | for how is makes your nose feel |
|---|
| Treatment Outcomes | 0.433 | 0.450 | 0.270 | 0.142 | 0.324 | 0.331 | 0.560 | 0.360 | 0.234 | 0.876 | 0.875 | 0.802 | 0.773 | 0.678 | 0.587 | 0.571 |
,| Treatment Process | 0.766 | 0.764 | 0.762 | 0.756 | 0.722 | 0.713 | 0.712 | 0.706 | 0.666 | 0.230 | 0.243 | 0.283 | 0.433 | 0.539 | 0.509 | 0.501 |
Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 2 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)
"Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 2 against the test criterion of no change (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction)." (NCT01287364)
Timeframe: Day 1 (pre-treatment) through Day 7 Treatment Period 2
| Intervention | scores on a scale (Mean) |
|---|
| Interference | Regimen Adaptation | Role Limitation | Regimen Difficulty | Sensory Impact | Hassle | Burden | Regimen Management | Perceived Relief | Overall Satisfaction |
|---|
| High Change | 6.612 | 4.242 | 4.688 | .309 | 3.200 | 10.273 | 4.602 | 1.524 | 8.424 | 4.875 |
,| Low Change | .8838 | -8.462 | 1.075 | -7.620 | -3.407 | -0.648 | 1.852 | 0.2521 | -6.512 | -2.510 |
,| Medium Change | 7.914 | -3.761 | 6.079 | -3.751 | -0.500 | 8.036 | 8.147 | 1.265 | -2.381 | 2.337 |
Sensitivity Analyses of Treatment Satisfaction Subscales: Standard Effect Sizes (SES)
"Within-and between-responder group standardized effect sizes (SES) were calculated. The generally accepted guidelines for clinically important standard effect sizes are small(0.2), medium (0.5), and large (0.8).~Between group SES indicates the magnitude of treatment differences. In this case, the groups were responders according to the baseline rTNSS scores. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction)." (NCT01287364)
Timeframe: Day 1 (Pre-treatment) through Day 29
| Intervention | standard effect sizes (Number) |
|---|
| Interference | Regimen Adaptation | Role Limitation | Regimen Difficulty | Sensory Impact | Hassle | Burden | Regimen Management | Perceived Relief |
|---|
| High Minus Low Response Group | 0.474 | 0.553 | 0.198 | 0.157 | 0.326 | 0.597 | 0.064 | 0.076 | 0.591 |
,| High Response Group | 0.893 | 0.534 | 0.920 | 0.098 | 0.843 | 0.926 | 0.761 | 0.728 | 0.439 |
,| Low Response Group | 0.551 | 0.057 | 0.722 | -0.057 | 0.720 | 0.466 | 0.898 | 0.656 | -0.114 |
Treatment Satisfaction Subscales (Interference, Regimen Adaptation, Role Limitations, Sensory Impact, Regimen Difficulties, Burden, Hassle, Regimen Management, and Perceived Relief)Reliability Statistics
Reliability for the nine treatment satisfaction subscales was established through internal consistency statistical analyses [Cronbach's alpha (raw and standardized) coefficients were calculated]. The correlation coefficients for these analyses ranged from 0.0 to 1.0, with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability. (NCT01287364)
Timeframe: Day 1 (Pre-treatment) through Day 7 Treatment Period 2
| Intervention | ratio of variance (Number) |
|---|
| Interference | Regimen Adaptation | Role Limitations | Sensory Impact | Regimen Difficulties | Hassle | Burden | Regimen Management | Perceived Relief |
|---|
| Average Cronbach's Alpha (Raw) Coefficients | 0.971 | 0.932 | 0.939 | 0.889 | 0.722 | 0.918 | 0.937 | 0.750 | 0.864 |
,| Average Cronbach's Alpha (Standardized) Coefficients | 0.972 | 0.932 | 0.944 | 0.895 | 0.731 | 0.928 | 0.938 | 0.804 | 0.871 |
Responsiveness Statistical Analysis of Treatment Satisfaction Subscales for Treatment Period 1 Versus Change in rTNSS From Baseline Categories (Low Change, Medium Change, or High Change)
"Analysis was conducted with one-sample t-tests on the treatment satisfaction subscale change scores for Treatment Period 1 against the test criterion of no change (ie, change score = 0)TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. TNSS values range from 0-12 (0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. All of the treatment satisfaction subscales and satisfaction scales were scored from 0 (low satisfaction) to 100 (high satisfaction)." (NCT01287364)
Timeframe: Day 1 (pre-treatment) through Day 7 Treatment Period 1
| Intervention | scores on a scale (Mean) |
|---|
| Interference | Regimen Adaptation | Role Limitation | Regimen Difficulty | Sensory Impact | Hassle | Burden | Regimen Management | Perceived Relief | Overall Satisfaction |
|---|
| High Change | 20.380 | 13.333 | 12.440 | 2.083 | 19.475 | 26.475 | 16.701 | 9.027 | 12.705 | 14.735 |
,| Low Change | 10.492 | 1.121 | 9.764 | -1.083 | 12.667 | 11.250 | 15.469 | 8.042 | -2.917 | 7.201 |
,| Medium Change | 15.836 | 12.121 | 10.512 | 3.760 | 13.226 | 17.742 | 16.331 | 9.348 | 8.280 | 11.906 |
Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose
The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray. (NCT01371786)
Timeframe: Day 1 at 2 minutes post dose
| Intervention | percentage of radiolabeled (Mean) |
|---|
| Ciclesonide Nasal Aerosol | 99.48 |
| Mometasone | 86.28 |
Initial Deposition of Radioactivity on Nasal Wipes as a Percent of Delivered Dose
The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray. (NCT01371786)
Timeframe: Day 1 at 2 minutes post-dose
| Intervention | percentage of radiolabeled (Mean) |
|---|
| Ciclesonide Nasal Aerosol | 0.49 |
| Mometasone | 12.15 |
Deposition of Radioactivity Within the Nasal Cavity Over 10 Minutes as a Percent of Delivered Dose
The scintigraphic measure of radioactivity deposited within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray. (NCT01371786)
Timeframe: Average of 2, 4, 6, 8 and 10 minutes post dose
| Intervention | percentage of of radiolabled (Mean) |
|---|
| Ciclesonide Nasal Aerosol | 89.61 |
| Mometasone | 69.15 |
Deposition of Radioactivity Within on Nasal Wipes Over 10 Minutes as a Percent of Delivered Dose
The scintigraphic measure of radioactivity deposited on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray. (NCT01371786)
Timeframe: Average of 2, 4, 6, 8, and 10 minutes post dose
| Intervention | percentage of radiolabeled (Mean) |
|---|
| Ciclesonide Nasal Aerosol | 0.98 |
| Mometasone | 13.15 |
Initial Deposition of Radioactivity Within the Nasopharynx as a Percent of Delivered Dose
The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasopharynx, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray. (NCT01371786)
Timeframe: Day 1 at 2 minutes post-dose
| Intervention | percentage of radiolabeled (Mean) |
|---|
| Ciclesonide Nasal Aerosol | 0.03 |
| Mometasone | 1.58 |
Change From Baseline in Congestion/Obstruction Score
At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline. (NCT01386125)
Timeframe: Baseline and Weeks 1-4
| Intervention | score on a scale (Least Squares Mean) |
|---|
| MFNS | -0.56 |
| Placebo | -0.42 |
Change From Baseline in Total Polyp Size Score
An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline. (NCT01386125)
Timeframe: Baseline and Week 16
| Intervention | score on a scale (Least Squares Mean) |
|---|
| MFNS | -0.76 |
| Placebo | -0.45 |
The Percentage of Subjects Experiencing AEs
(NCT01401465)
Timeframe: Over both two-week treatment periods combined
| Intervention | percentage of participants (Number) |
|---|
| Ciclesonide | 28.9 |
| Mometasone | 21.5 |
The Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
(NCT01401465)
Timeframe: Over both two-week treatment periods combined
| Intervention | percentage of participants (Number) |
|---|
| Ciclesonide | 1.9 |
| Mometasone | 1.3 |
Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items
"For the 17 individual items, patients were forced to choose their preference between ciclesonide and mometasone (item choices: 1 = prefer ciclesonide; 0 = prefer mometasone). The items for the Total Preference Score assessed 16 treatment attributes and one overall treatment preference: Ease of use, Convenience, Flexibility in daily activities, Taste, Use in public, Smell, Less run out of nose, Longer relief, Less run down of throat, Symptom relief, If both were the same price, Better appearance, Less nasal irritation, Faster relief, Number of sprays per dose, Makes nose feel, and Overall - the one preferred. The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates no preference and scores over 50 indicate preference for ciclesonide. This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide." (NCT01401465)
Timeframe: End of Study - Day 43
| Intervention | scores on a scale (Mean) |
|---|
| Ciclesonide Versus Mometasone | 68.3 |
Treatment Outcome Composite Score Assessed at the End of the Study
Reflects preference on items concerned with perceived drug effectiveness (longer relief; symptom relief; prefer if both were the same price; for feeling better about your appearance; for few problems with irritation to nose; faster relief; how it makes your nose feel). The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates an equal number of items preferred in the two groups. Larger values than 50 indicated greater than 50 percent of the subjects indicated preference for ciclesonide, while smaller values than 50 indicated greater than 50 percent preference for mometasone. Data is presented as the mean treatment outcome composite score. This analysis presents the comparison of ciclesonide versus mometasone in relation to preference for ciclesonide. (NCT01401465)
Timeframe: End of Study - Day 43
| Intervention | Scores on a scale (Mean) |
|---|
| Ciclesonide | 61.598 |
Treatment Process Composite Preference Score
"The Treatment Process Composite Preference Score is a standardized sum of 9 individual preference items (Ease of use, Convenience, Flexibility Daily Activity, Taste, Use in public, Smell. Less Run out of nose, Less Run down of throat, Number Sprays Dose). For each of these 9 individual items, patients were forced to choose their preference between ciclesonide nasal aerosol 74 mcg and mometasone AQ 200 mcg. Larger values greater than 50 indicated greater preference for ciclesonide, while smaller values less than 50 indicated greater preference for mometasone." (NCT01401465)
Timeframe: End of Study - Day 43
| Intervention | scores on a scale (Mean) |
|---|
| Ciclesonide | 74.087 |
Work/Disability Days: Bed Days
Assessed at the end of each two-week treatment period (NCT01401465)
Timeframe: Period 1 (days 0-14), Period 2 (days 29-43)
| Intervention | Incidence Rate (#events/person-days) (Number) |
|---|
| Period 1 | Period 2 |
|---|
| Ciclesonide | 0.018 | 0.009 |
,| Mometasone | 0.013 | 0.018 |
Work/Disability Days: Missed Work
Assessed at the end of each two-week treatment period (NCT01401465)
Timeframe: Period 1 (days 0-14), Period 2 (days 29-43)
| Intervention | Incidence Rate (#events/person-days) (Number) |
|---|
| Period 1 | Period 2 |
|---|
| Ciclesonide | 0.002 | 0.004 |
,| Mometasone | 0.005 | 0.004 |
Work/Disability Days: Reduced Activity Days
Assessed at the end of each two-week treatment period (NCT01401465)
Timeframe: Period 1 (days 0-14), Period 2 (days 29-43)
| Intervention | Incidence Rate (#events/person-days) (Number) |
|---|
| Period 1 | Period 2 |
|---|
| Ciclesonide | 0.039 | 0.017 |
,| Mometasone | 0.067 | 0.039 |
Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties
This subscale evaluates the patient's degree of pain, discomfort and side effects perceived to be associated with treatment, and the extent to which pain and discomfort were bothersome. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide | -7.58 |
| Mometasone | -0.13 |
Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation
This subscale evaluates the patient's assessment of the convenience of the treatment, whether the treatment was one the subject would recommend to other persons with the same condition, and the level of satisfaction with the current treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide | 6.65 |
| Mometasone | 2.19 |
Change From Baseline in the Treatment Satisfaction Rating Scale: Interference
This subscale evaluates the patient's assessment of the degree to which allergy symptoms or side effects of the nasal spray interfered with daily routine, meals, recreation, family life, sleep schedules, energy levels, making plans, traveling, having fun and overall quality of life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide | 17.31 |
| Mometasone | 14.36 |
Change From Baseline in the Treatment Satisfaction Rating Scale: Burden
This subscale evaluates the patient's assessment of the level of degree of burden that treatment for allergic rhinitis imposes on a number of areas, including adherence to the treatment regimen, exercise, performing daily activities, social activities, and enjoying life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide | 10.45 |
| Mometasone | 8.23 |
Change From Baseline in the Treatment Functional Impact Composite Score
A combination of the Interference Scale, the Role Limitation Scale, and the Burden Scale. The composite score and the subscales all range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales. (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42
| Intervention | scores on scale (Least Squares Mean) |
|---|
| Ciclesonide | 12.36 |
| Mometasone | 9.70 |
Change From Baseline in the Regimen Acceptance Composite Score
A combination of the Perceived Relief Scale and the Regimen Adaptation Scale. The composite score and all subscales range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales. (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Ciclesonide | 7.34 |
| Mometasone | 2.99 |
Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period.
The reflective Total Nasal Symptom Score (rTNSS) is the sum of 4 Nasal Symptoms: Runny Nose, Sneezing, Itchy Nose, and Nasal Congestion. These symptoms were assessed each morning and evening, and their totals averaged to obtain a daily average rTNSS. These daily averages were averaged over the 6 days prior to treatment to obtain the baseline value, and over the 14 days of each two-week period to obtain the on-treatment averages. The baseline values were then subtracted from the on-treatment averages to obtain the change from baseline scores. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild ,2 = moderate ,3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. (NCT01401465)
Timeframe: Averages over each two week treatment period
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide | -2.4 |
| Mometasone | -2.3 |
Change From Baseline in Regimen Attributes Composite Score
The Regimen Attributes Composite Score is a composite of the Sensory Impact and Regimen Management Scales of the Allergic Rhinitis Treatment Satisfaction and Preference Scales. The Regimen Management Scale assess patient satisfaction with issues relating to dosing, ability to remember to use the spray, the ease/difficulty of the spray, and convenience of the treatment. The Sensory Impact Scale assess patient satisfaction with issues relating to sensory attributes, including medication running out of the nose, medication running down the throat, impact on smell/taste, etc. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Ciclesonide | 13.90 |
| Mometasone | 4.88 |
Change From Baseline in the Treatment Satisfaction Rating Scale: Sensory Impact
This subscale evaluates the patient's assessment of the sensory attributes including medication running out of the nose, medication running down the throat, and impact on smell and taste. Issues regarding skipping the medication because of the way the nose feels and wanting to try other medications to find a better one are also included. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide | 21.37 |
| Mometasone | 4.41 |
Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation
This subscale evaluates the patient's assessment of the degree of interference with social interactions with family, friends, travel, having fun, problems in performing work or social roles and how flexible the treatment was with scheduling life activities. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide | 9.35 |
| Mometasone | 6.62 |
Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Management
This subscale evaluates the patient's assessment of issues relating to dosing (number of times and the time required to dose), ability to remember to use the spray, the ease/difficulty of the spray and several questions further pertaining to the convenience of the treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide | 6.41 |
| Mometasone | 5.38 |
The Change From Baseline in Overall Quality of Life Composite Score
Mean of all items in the Mental and Emotional Health and General Health Perceptions scales. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction) (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42
| Intervention | scores on a scale (Least Squares Mean) |
|---|
| Ciclesonide | 6.64 |
| Mometasone | 6.31 |
The Change From Baseline in the Treatment Satisfaction Rating Scale: Perceived Relief
The patient's perceived level of relief along with the degree of satisfaction associated with that amount of relief was evaluated within this scale. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide | 8.05 |
| Mometasone | 3.77 |
The Number of Subjects Experiencing AEs
(NCT01401465)
Timeframe: Over both two-week treatment periods combined
| Intervention | participants (Number) |
|---|
| Ciclesonide | 90 |
| Mometasone | 67 |
The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation
(NCT01401465)
Timeframe: Over both two-week treatment periods combined
| Intervention | participants (Number) |
|---|
| Ciclesonide | 6 |
| Mometasone | 4 |
Change From Baseline in the Treatment Satisfaction Rating Scale: Hassle
This subscale focuses specifically on the patient's assessment of the amount of bother and hassle of the treatment regimen, including coordinating activities, dosing, carrying supplies, rubbing nose or eyes, blowing nose repeatedly, or facial puffiness. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). (NCT01401465)
Timeframe: Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide | 24.7 |
| Mometasone | 17.4 |
Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms
The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant. (NCT01471340)
Timeframe: 26 weeks, or 7 days after the last treatment dose, whichever occurred later
| Intervention | Serious asthma outcomes (Number) |
|---|
| MF/F MDI BID | 39 |
| MF MDI BID | 32 |
Number of SAO Components in MF/F Participants vs MF Participants
To further examine the primary safety outcome, each adjudicated component of the SAO composite endpoint (asthma-related hospitalization, asthma-related intubation and asthma-related death), was tabulated for descriptive purposes only to show the relative contribution of each component to the SAO composite. Hospitalizations were defined as an in-patient stay of >= 24 hour in a hospital, emergency department or equivalent healthcare facility. Intubation was defined as endotracheal intubation only. (NCT01471340)
Timeframe: 26 weeks, or 7 days after the last treatment dose, whichever occurred later
| Intervention | SAO components (Number) |
|---|
| First SAO | Asthma-related hospitalizations | Asthma-related intubations | Asthma-related deaths |
|---|
| MF MDI BID | 32 | 32 | 0 | 0 |
,| MF/F MDI BID | 39 | 39 | 0 | 0 |
Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms
The key secondary efficacy outcome was time-to-first protocol-defined asthma exacerbation (SAEX). The SAEX were deteriorations of asthma requiring: use of systemic corticosteroids (tablets, suspension, or injection) for >= 3 consecutive days, in-patient hospitalization >= 24 hours, or an emergency department (ED) visit < 24 hours that required systemic corticosteroids in the MF/F MDI BID arm versus the MF MDI BID arm. The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment (modified intention-to-treat). This outcome was measured as the HR and 95% CI for the number of first SAEX in the MF/F MDI BID arm versus the number of first SAEX in the MF MDI BID arm. Given insufficient data for SAEX events, it was not informative to report the time-to-first SAEX in the overall population. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant. (NCT01471340)
Timeframe: 26 weeks, plus 7 days after the last treatment
| Intervention | Asthma exacerbations (Number) |
|---|
| MF/F MDI BID | 708 |
| MF MDI BID | 779 |
Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure. (NCT01502371)
Timeframe: Baseline and Week 12
| Intervention | Percentage of Predicted FEV1 (Least Squares Mean) |
|---|
| MF MDI 50 mcg BID | 4.52 |
| MF MDI 100 mcg BID | 6.95 |
| MF MDI 200 mcg BID | 6.00 |
| Placebo | 0.66 |
Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD
FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the secondary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI 50 mcg BID and MF DPI 100 mcg QD treatment groups. The comparisons between the other MF MDI BID and Placebo treatment groups are presented in a previous outcome measure. (NCT01502371)
Timeframe: Baseline and Week 12
| Intervention | Percentage of Predicted FEV1 (Least Squares Mean) |
|---|
| MF MDI 50 mcg BID | 4.52 |
| MF DPI 100 mcg QD | 3.13 |
Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo
The PAQLQ(S) consists of 23 questions in 3 categories: Symptoms (10 items), Activity Limitations (5 items), and Emotional Function (8 items). Responses are based on a 7-point scale (7=not bothered at all to 1=extremely bothered). PAQLQ(S) Total Scores could range from 23 to 161, with a lower score indicating a lower quality of life. The PAQLQ(S) included only participants in participating countries in which a validated translated questionnaire was available. The goal of the secondary outcome measure was to compare the change from Baseline in PAQLQ(S) between the MF MDI and Placebo treatment groups. (NCT01502371)
Timeframe: Baseline and Week 12
| Intervention | Score on a Scale (Least Squares Mean) |
|---|
| MF MDI 50 mcg BID | 0.35 |
| MF MDI 100 mcg BID | 0.38 |
| MF MDI 200 mcg BID | 0.44 |
| Placebo | 0.26 |
| MF DPI 100 mcg QD | 0.47 |
Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo
PEF, measured in liters per minute, is the highest flow during exhalation. Participants recorded diary entries for PEF twice daily (in the morning upon rising and in the evening at bedtime). The goal of the secondary outcome measure was to compare the change from Baseline in AM PEF between the MF MDI and Placebo treatment groups. (NCT01502371)
Timeframe: Baseline and Week 12
| Intervention | Liters/minute (Least Squares Mean) |
|---|
| MF MDI 50 mcg BID | 17.83 |
| MF MDI 100 mcg BID | 26.03 |
| MF MDI 200 mcg BID | 16.68 |
| Placebo | -1.32 |
| MF DPI 100 mcg QD | -0.92 |
Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis. (NCT01555151)
Timeframe: Days 8, 15 and 22
| Intervention | Liters (Least Squares Mean) |
|---|
| Day 8 (n=178,173,181,181) | Day 15 (n=179,171,177,178) | Day 22 (n=174,170,177,177) |
|---|
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | 2.057 | 2.048 | 2.071 |
,| Mometasone Furoate 320 ug Daily Via the Concept1 Device | 2.113 | 2.134 | 2.175 |
,| Mometasone Furoate 80 ug Daily Via the Concept1 Device | 2.069 | 2.095 | 2.126 |
,| Mometasone Furoate 800 ug Via the Twisthaler® Device | 2.111 | 2.135 | 2.146 |
Trough Forced Expiratory Volume in 1 Second (FEV1)
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment. (NCT01555151)
Timeframe: Day 29
| Intervention | Liters (Least Squares Mean) |
|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | 2.139 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | 2.071 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | 2.187 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | 2.162 |
Plasma Cortisol Concentrations
Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L (NCT01555151)
Timeframe: Baseline, days 1 and 28
| Intervention | nmol/L (Mean) |
|---|
| Baseline (n= 183, 178, 179, 181) | Day 1/1 Hr (n=179, 177,174, 176) | Day 28/-25 Mins (n= 172, 169, 174, 172) | Day 28/1 Hr (n= 172, 168, 174, 170) |
|---|
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | 143.132 | 106.965 | 140.604 | 107.931 |
,| Mometasone Furoate 320 ug Daily Via the Concept1 Device | 143.791 | 107.526 | 143.555 | 105.468 |
,| Mometasone Furoate 80 ug Daily Via the Concept1 Device | 150.040 | 118.130 | 140.760 | 105.399 |
,| Mometasone Furoate 800 ug Via the Twisthaler® Device | 150.108 | 115.489 | 145.484 | 110.477 |
Fractional Exhaled Nitric Oxide (FeNO)
FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment. (NCT01555151)
Timeframe: Days 15 and 29
| Intervention | ppm (Mean) |
|---|
| Day 15 (n= 142, 139, 139, 149) | Day 29 (n=141, 143, 145, 150) |
|---|
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | 26.762 | 27.055 |
,| Mometasone Furoate 320 ug Daily Via the Concept1 Device | 19.098 | 18.468 |
,| Mometasone Furoate 80 ug Daily Via the Concept1 Device | 25.286 | 23.777 |
,| Mometasone Furoate 800 ug Via the Twisthaler® Device | 21.017 | 19.981 |
Forced Vital Capacity (FVC) at All Time Points
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. (NCT01555151)
Timeframe: Days 1, 8, 15, 22, 28 and 29 at all time points
| Intervention | Liters (Least Squares Mean) |
|---|
| Day 1/30 min post-dose (n=172,172,175,173) | Day 1/1 hr post-dose (n=178,169,174,175) | Day 8/50 min pre-dose (n=174,171,179,174) | Day 8/15 min pre-dose (n=176,172,179,174) | Day 15 /50 min pre-dose (n=175,169,170,169) | Day 15/15 min pre-dose (n=176,168,176,167) | Day 22/50 min pre-dose (n=172,167,174,169) | Day 22/15 min pre-dose (n=169,170,174,172) | Day 28/50 min pre-dose (n=172,168,176,172) | Day 28/15 min pre-dose (n=170,165,174, 170) | Day 28/30 min post-dose (n=175,166,174,170) | Day 28/30 min post-dose (n=173,167,172,172) | Day 29/23hr 10 min post-dose (n=173,162,172,168) | Day 29/23hr 45 min post-dose (n=172,161, 175,170) |
|---|
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | 2.893 | 2.913 | 3.096 | 3.074 | 3.090 | 3.076 | 3.091 | 3.096 | 3.115 | 3.095 | 3.092 | 3.084 | 3.113 | 3.090 |
,| Mometasone Furoate 320 ug Daily Via the Concept1 Device | 2.861 | 2.943 | 3.134 | 3.121 | 3.168 | 3.137 | 3.203 | 3.198 | 3.184 | 3.153 | 3.151 | 3.158 | 3.216 | 3.192 |
,| Mometasone Furoate 80 ug Daily Via the Concept1 Device | 2.892 | 2.930 | 3.111 | 3.099 | 3.134 | 3.109 | 3.136 | 3.134 | 3.146 | 3.135 | 3.132 | 3.140 | 3.160 | 3.165 |
,| Mometasone Furoate 800 ug Via the Twisthaler® Device | 2.897 | 2.946 | 3.139 | 3.125 | 3.155 | 3.127 | 3.152 | 3.157 | 3.180 | 3.161 | 3.184 | 3.161 | 3.194 | 3.158 |
Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points
Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis. (NCT01555151)
Timeframe: Days 1, 8, 15, 22, 28 and 29 at all time points
| Intervention | Percent (Least Squares Mean) |
|---|
| Day 1/30 min post-dose (n=172,172,175,173) | Day 1/1 hr post-dose (n=178,169,174,175) | Day 8/50 min pre-dose (n=174,171,179,175) | Day 8/15 min pre-dose (n=176,172,179,174) | Day 15 /50 min pre-dose (n=176,169,170,169) | Day 15/15 min pre-dose (n=176,168,176,167) | Day 22/50 min pre-dose (n=172,167,174,169) | Day 22/15 min pre-dose (n=169,170,174,172) | Day 28/50 min pre-dose (n=172,168,176,172) | Day 28/15 min pre-dose (n=170,165,174, 170) | Day 28/30 min post-dose (n=175,166,174,170) | Day 28/30 min post-dose (n=173,167,172,172) | Day 29/23hr 10 min post-dose (n=173,162,172,168) | Day 29/23hr 45 min post-dose (n=172,161, 175,170) |
|---|
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | 64.898 | 64.833 | 66.301 | 66.790 | 66.122 | 66.006 | 66.567 | 66.885 | 66.835 | 67.296 | 67.013 | 66.832 | 66.711 | 66.541 |
,| Mometasone Furoate 320 ug Daily Via the Concept1 Device | 65.184 | 65.005 | 67.344 | 67.778 | 67.487 | 67.607 | 67.831 | 68.143 | 68.124 | 68.255 | 68.031 | 68.243 | 68.265 | 67.961 |
,| Mometasone Furoate 80 ug Daily Via the Concept1 Device | 65.043 | 65.177 | 66.566 | 66.595 | 67.007 | 66.878 | 67.081 | 67.403 | 67.128 | 67.503 | 67.700 | 67.945 | 67.427 | 67.630 |
,| Mometasone Furoate 800 ug Via the Twisthaler® Device | 64.898 | 65.072 | 66.568 | 67.156 | 67.139 | 67.514 | 67.742 | 67.895 | 67.810 | 67.878 | 68.126 | 68.057 | 67.592 | 67.831 |
Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment
"Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.~A day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication.~The total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use." (NCT01555151)
Timeframe: 4 weeks
| Intervention | percentage days (Least Squares Mean) |
|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | 74.148 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | 75.236 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | 75.157 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | 80.578 |
Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit
Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization). (NCT01555151)
Timeframe: Baseline, days 8,15,22 and 29
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| Day 8-baseline (n=179,176,182,182) | Day 15-baseline(n=180,174,179,178) | Day 22-baseline (n=178,173,178,177) | Day 29-baseline (n=179,176,181,182) |
|---|
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | -0.730 | -0.908 | -0.982 | -1.109 |
,| Mometasone Furoate 320 ug Daily Via the Concept1 Device | -0.908 | -1.117 | -1.262 | -1.329 |
,| Mometasone Furoate 80 ug Daily Via the Concept1 Device | -0.662 | -0.899 | -0.994 | -1.079 |
,| Mometasone Furoate 800 ug Via the Twisthaler® Device | -0.890 | -0.973 | -1.097 | -1.162 |
Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment
Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region. (NCT01555151)
Timeframe: Baseline and week 4
| Intervention | Liters per min (Least Squares Mean) |
|---|
| Morning 4 wks-baseline (n=177,171, 175, 182) | Evening 4 wks-baseline (n=176, 172, 174, 179) |
|---|
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | 3.955 | 0.293 |
,| Mometasone Furoate 320 ug Daily Via the Concept1 Device | 2.785 | -0.644 |
,| Mometasone Furoate 80 ug Daily Via the Concept1 Device | -4.952 | 1.354 |
,| Mometasone Furoate 800 ug Via the Twisthaler® Device | 1.606 | 6.287 |
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment
Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. (NCT01555151)
Timeframe: Baseline and 4 weeks
| Intervention | number of puffs (Least Squares Mean) |
|---|
| Mometasone Furoate 80 ug Daily Via the Concept1 Device | -0.456 |
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | -0.391 |
| Mometasone Furoate 320 ug Daily Via the Concept1 Device | -0.600 |
| Mometasone Furoate 800 ug Via the Twisthaler® Device | -0.677 |
Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points
The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. (NCT01555151)
Timeframe: Days 1, 8, 15, 22, 28 and 29 at all time points
| Intervention | Liters per second (Least Squares Mean) |
|---|
| Day 1/30 min post-dose (n=172,172,175,172) | Day 1/1 hr post-dose (n=178,169,174,174) | Day 8/50 min pre-dose (n=173,171,179,174) | Day 8/15 min pre-dose (n=175,172,179,173) | Day 15 /50 min pre-dose (n=175,169,170,169) | Day 15/15 min pre-dose (n=175,168,176,167) | Day 22/50 min pre-dose (n=171,167,174,169) | Day 22/15 min pre-dose (n=168,170,174,172) | Day 28/50 min pre-dose (n=171,168,176,172) | Day 28/15 min pre-dose (n=169,165,174, 170) | Day 28/30 min post-dose (n=175,166,174,170) | Day 28/30 min post-dose (n=172,167,172,172) | Day 29/23hr 10 min post-dose (n=172,162,172,168) | Day 29/23hr 45 min post-dose (n=171,161, 175,170) |
|---|
| Mometasone Furoate 200 ug Daily Via the Twisthaler® Device | 1.300 | 1.327 | 1.449 | 1.466 | 1.430 | 1.414 | 1.440 | 1.476 | 1.458 | 1.481 | 1.457 | 1.460 | 1.451 | 1.438 |
,| Mometasone Furoate 320 ug Daily Via the Concept1 Device | 1.309 | 1.316 | 1.519 | 1.542 | 1.514 | 1.520 | 1.565 | 1.600 | 1.581 | 1.574 | 1.557 | 1.577 | 1.604 | 1.576 |
,| Mometasone Furoate 80 ug Daily Via the Concept1 Device | 1.308 | 1.337 | 1.457 | 1.458 | 1.509 | 1.494 | 1.511 | 1.540 | 1.504 | 1.529 | 1.558 | 1.566 | 1.537 | 1.550 |
,| Mometasone Furoate 800 ug Via the Twisthaler® Device | 1.308 | 1.345 | 1.525 | 1.566 | 1.544 | 1.561 | 1.555 | 1.591 | 1.598 | 1.584 | 1.615 | 1.593 | 1.584 | 1.571 |
Number of Participants With At Least One Serious AE
"A serious AE was defined as any untoward medical occurrence or effect that at~any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer." (NCT01566149)
Timeframe: Up to Week 14
| Intervention | participants (Number) |
|---|
| MF/F 200/10 mcg MDI BID | 0 |
| MF/F 400/10 mcg MDI BID | 0 |
Number of Participants With At Least One Adverse Event (AE)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. (NCT01566149)
Timeframe: Up to Week 14
| Intervention | participants (Number) |
|---|
| MF/F 200/10 mcg MDI BID | 5 |
| MF/F 400/10 mcg MDI BID | 8 |
Number of Participants Who Discontinued From the Study Due to an AE
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. (NCT01566149)
Timeframe: Up to Week 12
| Intervention | participants (Number) |
|---|
| MF/F 200/10 mcg MDI BID | 0 |
| MF/F 400/10 mcg MDI BID | 1 |
Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Baseline was defined as the highest FEV1 value of three assessments prior to first dose of study drug. If two (or all three) spirometry efforts had identical FEV1, the FEV1 from the effort with the highest Forced Vital Capacity (FVC) was to be recorded. Week 12 FEV1 was assessed as the morning FEV1 at the end of the dosing interval (trough FEV1). For participants who discontinued prior to Week 12, the FEV1 measurement from the discontinuation visit was to be be carried forward to Week 12 if (and only if) the participant's study medication compliance rate prior to discontinuation was at least 85%. (NCT01566149)
Timeframe: Baseline and Week 12
| Intervention | liters (Mean) |
|---|
| Baseline FEV1 | Week 12 FEV1 | Change from Baseline in FEV1 at Week 12 |
|---|
| MF/F 200/10 mcg MDI BID | 2.397 | 2.503 | 0.106 |
,| MF/F 400/10 mcg MDI BID | 2.215 | 2.270 | 0.054 |
Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period
Total amounts (in doses) of systemic corticosteroids (SCS) used to treat asthma exacerbations.SCS includes Intramuscular (IM), Intravenous (IV) and Oral. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. (NCT01609478)
Timeframe: 12 weeks
| Intervention | milligrams (mg) (Mean) |
|---|
| IIntramuscular - Triamcinolone Acetonide | Intravenous - Betamethasone | Intravenous- Hydrocortisone | Intravenous- Hydrocortisone NA Succinate | Intravenous- Methylprednisolone NA Succinate | Oral- Methylprednisolone | Oral - Prednisolone | Oral - Prednisone | Oral - Prednisone equivalent dose |
|---|
| Indacaterol Acetate 150 µg | 20 | 4 | 100 | 500 | 80 | 32 | 90 | 40 | 106.11 |
,| Indacaterol Acetate 75 µg | NA | NA | 500 | 300 | 60 | NA | 60 | 40 | 102 |
,| Placebo | 0 | 4 | 200 | NA | NA | NA | 37.50 | 100 | 58.61 |
Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 2 weeks (Day 15), 4 weeks (Day 29), and 8 weeks (Day 57) of treatment. (NCT01609478)
Timeframe: Day 15, Day 29 and Day 57
| Intervention | Liters (Least Squares Mean) |
|---|
| Day 15 | Day 29 | Day 57 |
|---|
| Indacaterol Acetate 150 µg | 2.198 | 2.196 | 2.227 |
,| Indacaterol Acetate 75 µg | 2.169 | 2.180 | 2.180 |
,| Placebo | 2.069 | 2.057 | 2.099 |
Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points
Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. FVC is measured on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at all time points (NCT01609478)
Timeframe: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
| Intervention | liters (Least Squares Mean) |
|---|
| Day 1 / 5 min post-dose (n=107,105,111) | Day 1 / 15 min post-dose (n=107,105,111) | Day 1 / 30 min post-dose (n=107,104,111) | Day 1 / 1 hr post-dose (n=107,104,111) | Day 1 / 2 hr post-dose (n=106,104,111) | Day 1 / 4 hr post-dose (n=107,101,111) | Day 1 / 6 hr post-dose (n=24,24,26) | Day 2 / 23 hr 10min post-dose (n=107,104,110) | Day 2 / 23 hr 45min post-dose (n=107,104,111) | Day 14 / 5 min post-dose (n=107,105,111) | Day 14 / 15 min post-dose (n=107,105,111) | Day 14 / 30 min post-dose (n=107,104,111) | Day 14 / 1 hr post-dose (n=107,104,111) | Day 14 / 2 hr post-dose (n=106,104,111) | Day 14 / 4 hr post-dose (n=107,101,111) | Day 14 / 6 hr post-dose (n=24,24,26) | Day 15 / 23 hr 10min post-dose (n=107,104,110) | Day 15 / 23 hr 45min post-dose (n=107,104,111) | Day 84 / 5 min post-dose (n=107,105,111) | Day 84 / 15 min post-dose (n=107,105,111) | Day 84 / 30 min post-dose (n=107,104,111) | Day 84 / 1hr post-dose (n=107,104,111) | Day 84 / 2 hr post-dose (n=106,104,111) | Day 84 / 4 hr post-dose (n=106,101,111) | Day 85 / 23 hr 10min post-dose (n=107,104,110) | Day 85 / 23 hr 45min post-dose (n=107,104,111) |
|---|
| Indacaterol Acetate 150 µg | 3.338 | 3.348 | 3.367 | 3.333 | 3.367 | 3.342 | 3.345 | 3.303 | 3.341 | 3.364 | 3.377 | 3.389 | 3.379 | 3.395 | 3.338 | 3.426 | 3.311 | 3.313 | 3.374 | 3.392 | 3.399 | 3.393 | 3.382 | 3.363 | 3.300 | 3.321 |
,| Indacaterol Acetate 75 µg | 3.342 | 3.372 | 3.378 | 3.356 | 3.366 | 3.346 | 3.299 | 3.314 | 3.313 | 3.404 | 3.397 | 3.412 | 3.408 | 3.402 | 3.368 | 3.332 | 3.324 | 3.347 | 3.381 | 3.393 | 3.424 | 3.394 | 3.413 | 3.346 | 3.350 | 3.343 |
,| Placebo | 3.235 | 3.238 | 3.239 | 3.241 | 3.268 | 3.238 | 3.280 | 3.254 | 3.269 | 3.212 | 3.213 | 3.246 | 3.206 | 3.207 | 3.217 | 3.257 | 3.237 | 3.260 | 3.263 | 3.275 | 3.282 | 3.262 | 3.292 | 3.257 | 3.287 | 3.294 |
Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)
The Asthma Control Questionnaire (ACQ-5) is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. (NCT01609478)
Timeframe: aftert 12 weeks (Day 85)
| Intervention | Units on a Scale (Least Squares Mean) |
|---|
| Indacaterol Acetate 75 µg | 1.31 |
| Indacaterol Acetate 150 µg | 1.42 |
| Placebo | 1.32 |
The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period
The percentage of patients who permanently discontinued study due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. (NCT01609478)
Timeframe: 12 weeks
| Intervention | percentage of participants (Number) |
|---|
| Indacaterol Acetate 75 µg | 1.9 |
| Indacaterol Acetate 150 µg | 1.0 |
| Placebo | 3.6 |
Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period
Time to permanent study discontinuation due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. (NCT01609478)
Timeframe: 12 weeks
| Intervention | days (Median) |
|---|
| Indacaterol Acetate 75 µg | NA |
| Indacaterol Acetate 150 µg | NA |
| Placebo | NA |
Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85) (NCT01609478)
Timeframe: after 12 weeks (Day 85)
| Intervention | Liters (Least Squares Mean) |
|---|
| Indacaterol Acetate 75 µg | 2.190 |
| Indacaterol Acetate 150 µg | 2.216 |
| Placebo | 2.110 |
Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment
The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). (NCT01609478)
Timeframe: after 4 weeks (Day 29) and after 8 weeks (Day 57)
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Day 29 (n=103, 104, 108) | Day 57 (n= 103, 104, 108) |
|---|
| Indacaterol Acetate 150 µg | 1.39 | 1.29 |
,| Indacaterol Acetate 75 µg | 1.43 | 1.42 |
,| Placebo | 1.55 | 1.46 |
Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment
The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score. (NCT01609478)
Timeframe: 4 Weeks, 12 Weeks
| Intervention | Units on a Scale (Least Squares Mean) |
|---|
| Day 29 (n=103,104, 108) | Day 85 (n=103,104, 108) |
|---|
| Indacaterol Acetate 150 µg | 5.48 | 5.47 |
,| Indacaterol Acetate 75 µg | 5.52 | 5.64 |
,| Placebo | 5.38 | 5.60 |
Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
Duration of asthma exacerbations by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. (NCT01609478)
Timeframe: 12 weeks
| Intervention | days (Mean) |
|---|
| moderate or severe exacerbations | any asthma exacerbations | mild asthma exacerbations | moderate asthma exacerbations | Severe asthma exacerbations |
|---|
| Indacaterol Acetate 150 µg | 0.6 | 0.9 | 0.4 | 0.6 | 0.0 |
,| Indacaterol Acetate 75 µg | 0.7 | 1.0 | 0.3 | 0.6 | 0.1 |
,| Placebo | 0.8 | 1.3 | 0.5 | 0.6 | 0.1 |
Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Forced Expiratory Flow (FEF 25-75%) was measured via spirometry conducted according to internationally accepted standards. (NCT01609478)
Timeframe: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
| Intervention | liters/second (Least Squares Mean) |
|---|
| Day 1 / 5 min post-dose (n=107,105,111) | Day 1 / 15 min post-dose (n=107,105,111) | Day 1 / 30 min post-dose (n=107,104,111) | Day 1 / 1 hr post-dose (n=107,104,111) | Day 1 / 2 hr post-dose (n=106,104,111) | Day 1 / 4 hr post-dose (n=107,101,111) | Day 1 / 6 hr post-dose (n=24,24,26) | Day 2 / 23 hr 10min post-dose (n=107,104,110) | Day 2 / 23 hr 45min post-dose (n=107,104,111) | Day 14 / 5 min post-dose (n=107,105,111) | Day 14 / 15 min post-dose (n=107,105,111) | Day 14 / 30 min post-dose (n=107,104,111) | Day 14 / 1 hr post-dose (n=107,104,111) | Day 14 / 2 hr post-dose (n=106,104,111) | Day 14 / 4 hr post-dose (n=107,101,111) | Day 14 / 6 hr post-dose (n=24,24,26) | Day 15 / 23 hr 10min post-dose (n=107,104,110) | Day 15 / 23 hr 45min post-dose (n=107,104,111) | Day 84 / 5 min post-dose (n=107,105,111) | Day 84 / 15 min post-dose (n=107,105,111) | Day 84 / 30 min post-dose (n=107,104,111) | Day 84 / 1hr post-dose (n=107,104,111) | Day 84 / 2 hr post-dose (n=106,104,111) | Day 84 / 4 hr post-dose (n=106,101,111) | Day 85 / 23 hr 10min post-dose (n=107,104,110) | Day 85 / 23 hr 45min post-dose (n=107,104,111) |
|---|
| Indacaterol Acetate 150 µg | 1.485 | 1.563 | 1.568 | 1.594 | 1.632 | 1.625 | 1.620 | 1.520 | 1.524 | 1.571 | 1.597 | 1.607 | 1.664 | 1.676 | 1.628 | 1.519 | 1.442 | 1.492 | 1.627 | 1.675 | 10659 | 1.687 | 1.704 | 1.648 | 1.507 | 1.496 |
,| Indacaterol Acetate 75 µg | 1.420 | 1.449 | 1.467 | 1.471 | 1.508 | 1.479 | 1.364 | 1.407 | 1.436 | 1.505 | 1.540 | 1.532 | 1.569 | 1.551 | 1.526 | 1.370 | 1.421 | 1.430 | 1.535 | 1.530 | 1.548 | 1.578 | 1.571 | 1.548 | 1.437 | 1.476 |
,| Placebo | 1.295 | 1.295 | 1.310 | 1.297 | 1.348 | 1.329 | 1.332 | 1.310 | 1.326 | 1.318 | 1.351 | 1.336 | 1.343 | 1.338 | 1.339 | 1.363 | 1.315 | 1.319 | 1.363 | 1.372 | 1.368 | 1.404 | 1.382 | 1.350 | 1.328 | 1.378 |
Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. (NCT01609478)
Timeframe: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
| Intervention | ratio (Least Squares Mean) |
|---|
| Day 1 / 5 min post-dose (n=107,105,111) | Day 1 / 15 min post-dose (n=107,105,111) | Day 1 / 30 min post-dose (n=107,104,111) | Day 1 / 1 hr post-dose (n=107,104,111) | Day 1 / 2 hr post-dose (n=106,104,111) | Day 1 / 4 hr post-dose (n=107,101,111) | Day 1 / 6 hr post-dose (n=24,24,26) | Day 2 / 23 hr 10min post-dose (n=107,104,110) | Day 2 / 23 hr 45min post-dose (n=107,104,111) | Day 14 / 5 min post-dose (n=107,105,111) | Day 14 / 15 min post-dose (n=107,105,111) | Day 14 / 30 min post-dose (n=107,104,111) | Day 14 / 1 hr post-dose (n=107,104,111) | Day 14 / 2 hr post-dose (n=106,104,111) | Day 14 / 4 hr post-dose (n=107,101,111) | Day 14 / 6 hr post-dose (n=24,24,26) | Day 15 / 23 hr 10min post-dose (n=107,104,110) | Day 15 / 23 hr 45min post-dose (n=107,104,111) | Day 84 / 5 min post-dose (n=107,105,111) | Day 84 / 15 min post-dose (n=107,105,111) | Day 84 / 30 min post-dose (n=107,104,111) | Day 84 / 1hr post-dose (n=107,104,111) | Day 84 / 2 hr post-dose (n=106,104,111) | Day 84 / 4 hr post-dose (n=106,101,111) | Day 85 / 23 hr 10min post-dose (n=107,104,110) | Day 85 / 23 hr 45min post-dose (n=107,104,111) |
|---|
| Indacaterol Acetate 150 µg | 66.049 | 67.039 | 67.189 | 67.620 | 67.824 | 67.968 | 68.846 | 66.942 | 66.791 | 67.366 | 67.577 | 67.765 | 68.262 | 68.397 | 68.044 | 67.346 | 65.930 | 66.435 | 67.762 | 67.907 | 67.865 | 3.393 | 3.382 | 3.363 | 3.300 | 3.321 |
,| Indacaterol Acetate 75 µg | 65.608 | 65.602 | 65.738 | 66.089 | 66.607 | 66.094 | 64.716 | 65.465 | 65.809 | 66.548 | 67.187 | 67.024 | 67.100 | 67.538 | 66.866 | 64.792 | 65.436 | 65.606 | 67.040 | 67.162 | 66.936 | 3.394 | 3.413 | 3.346 | 3.350 | 3.343 |
,| Placebo | 63.461 | 63.537 | 63.767 | 63.744 | 64.141 | 64.212 | 63.773 | 63.822 | 63.741 | 64.362 | 64.702 | 64.192 | 64.383 | 64.617 | 64.426 | 64.167 | 64.027 | 63.726 | 64.850 | 65.074 | 64.848 | 3.262 | 3.292 | 3.257 | 3.287 | 3.294 |
Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.
PEFR is measured with portable spirometer by participants every morning and evening at home. (NCT01609478)
Timeframe: baseline, 4weeks, 8 weeks and 12 weeks
| Intervention | liters/second (Least Squares Mean) |
|---|
| Morning Baseline - <4 weeks (n=104,100,109) | Evening baseline - <4 weeks (n=104,100,109) | Morning 4 weeks - <8 weeks (n=104,100,109) | Evening 4 weeks - <8 weeks (n=104,100,109) | Morning 8 weeks - <12 weeks (n=104,100,109) | Evening 8 weeks - <12 weeks (n=104,100,109) |
|---|
| Indacaterol Acetate 150 µg | 335.44 | 345.99 | 338.23 | 344.63 | 334.83 | 342.40 |
,| Indacaterol Acetate 75 µg | 326.98 | 332.96 | 328.45 | 333.36 | 329.85 | 332.61 |
,| Placebo | 307.68 | 312.42 | 315.60 | 313.31 | 317.03 | 316.28 |
Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)
Peak Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks. (NCT01609478)
Timeframe: Day 1, 2 weeks (Day 14), 12 weeks (Day 84)
| Intervention | liters (Least Squares Mean) |
|---|
| Day 1 | Day 14 | Day 84 |
|---|
| Indacaterol Acetate 150 µg | 2.353 | 2.387 | 2.403 |
,| Indacaterol Acetate 75 µg | 2.287 | 2.345 | 2.345 |
,| Placebo | 2.172 | 2.165 | 2.215 |
Plasma Indacaterol Concentrations at Day 1 and Day 14
Maximum plasma concentration after drug administration (Cmax) was measured for indacaterol acetate 75 µg and indacaterol acetate 150 µg for Pharmacokinetic (PK) Subgroup (NCT01609478)
Timeframe: Day 1 and Day 14
| Intervention | pg/ml (Mean) |
|---|
| Day 1 (n=21, 21) | Day 14 (n=21, 21) |
|---|
| Indacaterol Acetate 150 µg | 164 | 285 |
,| Indacaterol Acetate 75 µg | 70.7 | 129 |
Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)
Forced Expiratory Volume in 1 second (FEV1)/Area Under the Curve(AUC) was measured via spirometry conducted according to internationally accepted standards.FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1, 2 Weeks (Day 14) and 12 Weeks (Day84) and defined as average of FEV1 at specified timepoints above. (NCT01609478)
Timeframe: Day 1, 2 Weeks, 12 Weeks
| Intervention | Liters (Least Squares Mean) |
|---|
| Day 1 (5min-4h) (n=107,105,111) | Day 1 (5min-1h) (n=107,105,111) | Day 1 (1h-4h) (n=107,104,111) | Day 14 (5min-4h) (n=107,105,111) | Day 14 (5min-1h) (n=107,105,111) | Day 14 (1h-4h) (n=107,104,111) | Day 84 (5min-4h) (n=107,105,111) | Day 84 (5min-1h) (n=107,105,111) | Day 84 (1h-4h) (n=107,104,111) |
|---|
| Indacaterol Acetate 150 µg | 2.274 | 2.253 | 2.284 | 2.313 | 2.299 | 2.318 | 2.322 | 2.321 | 2.322 |
,| Indacaterol Acetate 75 µg | 2.209 | 2.198 | 2.212 | 2.265 | 2.267 | 2.262 | 2.264 | 2.265 | 2.263 |
,| Placebo | 2.077 | 2.059 | 2.082 | 2.074 | 2.069 | 2.066 | 2.132 | 2.119 | 2.130 |
The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. Number of the asthma exacerbation will be analyzed by the negative binomial regression including treatment, history of asthma exacerbation in the 12 months prior to screening and region as factors and FEV1 prior to inhalation and FEV1 30 min post inhalation of salbutamol/albuterol (components of SABA reversibility) as covariates. The estimates are obtained from the model and so we cannot specify a formula. (NCT01609478)
Timeframe: 12 weeks
| Intervention | # of exacerbations (Number) |
|---|
| Moderate or Severe Exacerbation | Any asthma exacerbation | Mild Asthma Exacerbation | Moderate Asthma Exacerbation | Severe Asthma Exacerbation |
|---|
| Indacaterol Acetate 150 µg | 0.353 | 0.569 | 0.001 | 0.320 | 0.000 |
,| Indacaterol Acetate 75 µg | 0.315 | 0.421 | 0.000 | 0.225 | 0.000 |
,| Placebo | 0.352 | 0.788 | 0.001 | 0.274 | 0.000 |
The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
The percentage of patients with at least one asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. (NCT01609478)
Timeframe: 12 weeks
| Intervention | percentage of participants (Number) |
|---|
| moderate or severe asthma exacerbations | any asthma exacerbations | mild asthma exacerbations | moderate asthma exacerbations | severe asthma exacerbations |
|---|
| Indacaterol Acetate 150 µg | 5.7 | 8.6 | 3.8 | 5.7 | 0.0 |
,| Indacaterol Acetate 75 µg | 5.6 | 8.4 | 2.8 | 4.7 | 0.9 |
,| Placebo | 4.5 | 9.9 | 5.4 | 4.5 | 0.9 |
The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment
Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and nighttime. (NCT01609478)
Timeframe: 12 weeks
| Intervention | number of puffs (Least Squares Mean) |
|---|
| Mean daily number of puffs (n=105, 102, 105) | Mean Daytime number of puffs (n=103, 99, 100) | Mean nighttime number of puffs (n=104, 100, 107) |
|---|
| Indacaterol Acetate 150 µg | 0.99 | 0.55 | 0.47 |
,| Indacaterol Acetate 75 µg | 1.08 | 0.54 | 0.55 |
,| Placebo | 1.31 | 0.73 | 0.64 |
Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
Duration of treatment until first asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. (NCT01609478)
Timeframe: 12 weeks
| Intervention | weeks (Median) |
|---|
| Moderate or Severe exacerbation | Any Asthma Exacerbation | Mild Asthma Exacerbation | Moderate Asthma Exacerbation | Severe Asthma Exacerbation |
|---|
| Indacaterol Acetate 150 µg | NA | NA | NA | NA | NA |
,| Indacaterol Acetate 75 µg | NA | NA | NA | NA | NA |
,| Placebo | NA | NA | NA | NA | NA |
Change in Steroid Sensitivity in Vivo Nasal Endoscopy Polyp Scores
To assess steroid sensitivity in subjects comparing nasal endoscopy polyp score before and following 4 weeks treatment with mometasone furoate nasal spray (MFNS). Nasal endoscopic polyp score measured on 0 to 4 scale ( 0 = no nasal polyp; 1 = polyp in the middle meatus, not below the inferior border of the middle turbinate (MT); 2 = polyp below the inferior border of the MT but not touching the inferior turbinate (IT); 3 = polyp below the inferior border of the MT and touching the IT; 4 = polyp to or below the lower border of the IT). The outcome is the difference in mean score (Post - Pre). A negative difference would indicate that patients had a reduction in nasal polyp size at the end of the study. (NCT01616160)
Timeframe: Change between pre- and post-treatment symptom score after 4 weeks of treatment
| Intervention | units on a scale (Mean) |
|---|
| Right nasal polyp | Left nasal polyp |
|---|
| Nasal Polyps Subjects | 0 | -0.25 |
Change in Steroid Sensitivity in Vivo Symptom Scores - Trouble With Sense of Smell
To assess steroid sensitivity in subjects comparing Trouble with sense of smell symptom scores before and following 4 weeks treatment with mometasone furoate nasal spray (MFNS). Trouble with sense of smell measured on 0 to 4 scale ( 0 = no trouble with smell; 4 = severe trouble with smell). The outcome is the difference in mean score (Post - Pre). A negative difference would indicate patients had less trouble with sense of smell at the end of the study. (NCT01616160)
Timeframe: Change between pre- and post-treatment symptom score after 4 weeks of treatment
| Intervention | scores on a scale (Mean) |
|---|
| Nasal Polyps Subjects | -0.9 |
Medication Side-effect and Compliance Inventory
The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study. (NCT01676415)
Timeframe: 4-6 weeks and 3 months after initiation of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Prednisone | 0 |
| Topical Mometasone | 0 |
Taskforce Symptom Inventory
Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS. (NCT01676415)
Timeframe: 4-6 weeks and 3 months after initiation of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Prednisone | 0 |
| Topical Mometasone | 0 |
SNOT-22 Questionnaire
"The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms (nasal obstruction and loss of smell and taste) ranked from 0 (not a problem) to 5 (problem as bad as it can be).~Min score= 0, Max score= 110 (worst possible problem on all symptoms)~Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis." (NCT01676415)
Timeframe: 4-6 weeks and 3 months after initiation of treatment
| Intervention | units on a scale (Mean) |
|---|
| 4-6 WEEKS | 3 MONTHS |
|---|
| Prednisone | 45.75 | 49 |
,| Topical Mometasone | 34.4 | 34.4 |
Number of Participants Who Experience At Least One Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT01700192)
Timeframe: Up to 54 weeks
| Intervention | Participants (Number) |
|---|
| MK-8237 | 676 |
| Placebo | 539 |
Number of Participants Who Discontinue Study Drug Due to an AE
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT01700192)
Timeframe: Up to 52 weeks
| Intervention | Participants (Number) |
|---|
| MK-8237 | 73 |
| Placebo | 19 |
Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment
The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)
| Intervention | Score on a Scale (Mean) |
|---|
| MK-8237 | 6.40 |
| Placebo | 7.62 |
Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)
| Intervention | Score on a Scale (Mean) |
|---|
| MK-8237 | 4.67 |
| Placebo | 5.49 |
Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)
| Intervention | Score on a Scale (Mean) |
|---|
| MK-8237 | 3.83 |
| Placebo | 4.46 |
Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment
The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment. (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)
| Intervention | Score on a Scale (Mean) |
|---|
| MK-8237 | 0.84 |
| Placebo | 1.03 |
Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment
"Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 (no symptoms) to 100 (severe symptoms). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores)." (NCT01700192)
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)
| Intervention | Score on a Scale (Mean) |
|---|
| MK-8237 | 42.29 |
| Placebo | 47.96 |
Bilateral Polyp Grade
Polyps were graded by clinical investigators on a scale from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicate reduction (improvement) in nasal polyps. (NCT01732536)
Timeframe: 90 days, 6 months
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 90 days | Change from baseline to 90 days | Month 6 | Change from baseline to 6 months |
|---|
| Control | 4.32 | 4.24 | -0.09 | 4.36 | 0.02 |
,| S8 Sinus Implant | 4.68 | 3.65 | -1.04 | 3.96 | -0.71 |
Bilateral Polyp Grade
Polyp grade was determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline represented reduction (improvement) in bilateral polyp grade. (NCT01732536)
Timeframe: 90 days
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 90 | Change from baseline |
|---|
| Control | 4.39 | 4.00 | -0.38 |
,| Treatment | 4.90 | 4.12 | -0.76 |
Ethmoid Sinus Obstruction
Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline represented reduction (improvement) in ethmoid sinus obstruction. (NCT01732536)
Timeframe: 90 days
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 90 | Change from baseline |
|---|
| Control | 62.74 | 57.17 | -5.57 |
,| S8 Sinus Implant | 70.59 | 53.54 | -17.05 |
Nasal Obstruction Symptom Evaluation (NOSE) Score
NOSE scale is a validated symptom scoring instrument consisting of 5 questions each scored by patients on a 5-point Likert scale from 0 (not a problem) to 4 (severe problem), then multiplied by 5 and resulting in a total score ranging from 0 to 100. Negative values for change from baseline represented reduction (improvement) in NOSE score. (NCT01732536)
Timeframe: 6 months
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Month 6 | Change from baseline |
|---|
| Control | 63.19 | 50.67 | -12.22 |
,| S8 Sinus Implant | 66.79 | 41.83 | -25.58 |
Nasal Obstruction/Congestion Score
Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in (NCT01732536)
Timeframe: 90 days
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 90 | Change from baseline |
|---|
| Control | 3.30 | 2.62 | -0.67 |
,| Treatment | 3.62 | 2.31 | -1.33 |
Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)
"To be indicated for RESS, the following criteria had to be met:~Continued to use topical intranasal steroids daily;~Continued to complain of at least 2 symptoms of chronic sinusitis despite ongoing topical intranasal steroid use~Needed or had received at least 1 course of aggressive steroid therapy or had refused such therapy due to intolerance/side effects; and~Had endoscopic evidence of persisting ethmoid sinus obstruction (bilateral polyp grade >=2 on at least one side)" (NCT01732536)
Timeframe: 90 days, 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Baseline | Day 90 | Month 6 |
|---|
| Control | 47 | 36 | 41 |
,| S8 Sinus Implant | 53 | 25 | 36 |
Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14.
"The Total Nasal Symptom Score Scale was used. Patients rated each of the following four symptoms on a scale from 0 to 3 : Nasal Congestion, Runny Nose, Sneezing, and Itchy Nose. Measurements were taken twice daily approximately 12 hours apart.~0= No symptom~Mild symptoms (sign/symptom present, minimal awareness, easily tolerated)~Moderate symptom (definite awareness of sign/symptom, bothersome but tolerable)~Severe symptom (sign/symptom hard to tolerate, causes interference with daily activities and/or sleeping)" (NCT01850823)
Timeframe: Twice daily from Baseline to 2 weeks
| Intervention | score on a scale (Mean) |
|---|
| NASONEX® Nasal Spray (Schering Corporation) | 1.861 |
| Mometasone Nasal Spray (Watson Laboratories, Inc) | 1.600 |
Superiority of Active Treatment Arms Over Placebo
"Superiority analysis of Change From Baseline in rTNSS for both active arms compared to placebo arm. The Total Nasal Symptom Score Scale was used. Patients rated each of the following four symptoms on a scale from 0 to 3: Nasal Congestion, Runny Nose, Sneezing, and Itchy Nose twice daily approximately 12 hours apart.~0= No symptom~Mild symptoms (sign/symptom present, minimal awareness, easily tolerated)~Moderate symptom (definite awareness of sign/symptom, bothersome but tolerable)~Severe symptom (sign/symptom hard to tolerate, causes interference with daily activities and/or sleeping)" (NCT01850823)
Timeframe: Twice daily from Baseline to 2 weeks
| Intervention | score on a scale (Mean) |
|---|
| Placebo | 0.898 |
| NASONEX® Nasal Spray (Schering Corporation) | 1.609 |
| Mometasone Nasal Spray (Watson Laboratories, Inc) | 1.863 |
Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up
The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Responses to the Skindex-16 are categorized into three subscales: symptom, emotional, and functional. Scores for the emotions, symptoms and functioning scales are also expressed in a linear scale from 0 to 100. Rankings of the questionnaire are then averaged to obtain a score of severity of patient-reported outcomes. This allows providers to gauge which aspects of the participant's experience are most affected by the treatment. (NCT01856543)
Timeframe: 2 weeks after end of Radiation Therapy
| Intervention | scores on a scale (Median) |
|---|
| Emotions | Symptoms | Functioning |
|---|
| Eucerin | 15.0 | 11.0 | 6.0 |
,| Mometasone Furoate 0.1% | 12.0 | 11.0 | 5.0 |
Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment
The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Responses to the Skindex-16 are categorized into three subscales: symptom, emotional, and functional. Scores for the emotions, symptoms and functioning scales are also expressed in a linear scale from 0 to 100. Rankings of the questionnaire are then averaged to obtain a score of severity of patient-reported outcomes. This allows providers to gauge which aspects of the participant's experience are most affected by the treatment. (NCT01856543)
Timeframe: 5 weeks and Baseline
| Intervention | score on a scale (Median) |
|---|
| Emotions | Symptoms | Functioning |
|---|
| Eucerin | 8.0 | 6.0 | 2.0 |
,| Mometasone Furoate 0.1% | 5.0 | 6.0 | 1.0 |
Percentage of Participants With Moist Desquamation
Skin toxicity assessments will be done on a weekly basis while the patient is receiving RT, by the RN or physician utilizing CTCAE 4.0 and the weekly status check form, as per current standard practice. (NCT01856543)
Timeframe: 2 years
| Intervention | % of participants w/moist desquamation (Number) |
|---|
| Eucerin | 66.7 |
| Mometasone Furoate 0.1% | 43.8 |
Number of Sinuses With Successful Implant Delivery
Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure (NCT01894503)
Timeframe: End of baseline procedure
| Intervention | Sinuses (Count of Units) |
|---|
| S8 Sinus Implant | 10 |
Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score
CT scan assessment included Lund-Mackay score and percent of the maxillary sinuses occupied by disease. The Lund-Mackay scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses. The total score ranges from 0 (normal) - 24 (more opacified); higher score indicated worse status. (NCT01920893)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) |
|---|
| Placebo | -0.23 |
| Dupilumab 300 mg QW | -9.24 |
Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16
Morning symptoms of sinusitis (nasal congestion/obstruction, anterior rhinorrhea [runny nose], posterior rhinorrhea [post nasal drip], and loss of sense of smell) were assessed using a 0 (no symptoms) - 3 (severe symptoms) categorical scale where higher score indicated severe symptoms. (NCT01920893)
Timeframe: Baseline, Week 16
| Intervention | score on a scale (Mean) |
|---|
| Congestion/obstruction | Runny nose | Post nasal drip | Loss of sense of smell |
|---|
| Dupilumab 300 mg QW | -0.95 | -0.62 | -0.49 | -1.36 |
,| Placebo | -0.26 | -0.1 | -0.15 | -0.3 |
Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease
CT scan assessment included Lund-Mackay score and percentage of the area of maxillary sinuses occupied by disease. (NCT01920893)
Timeframe: Baseline, Week 16
| Intervention | percent area (Mean) |
|---|
| Placebo | -3.92 |
| Dupilumab 300 mg QW | -35.66 |
Change From Baseline in Nasal Total Symptoms Score (nTSS) at Week 16
nTSS was the sum of participant-assessed nasal symptom scores for nasal congestion/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale. Total score ranges from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated severe symptoms. (NCT01920893)
Timeframe: Baseline, Week 16
| Intervention | score on a scale (Mean) |
|---|
| nTSS - Morning | nTSS - Evening |
|---|
| Dupilumab 300 mg QW | -2.87 | -2.9 |
,| Placebo | -0.68 | -0.77 |
Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16
NPIF evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration and/or expiration expressed in liter per minute. (NCT01920893)
Timeframe: Baseline, Week 16
| Intervention | liter/minute (Mean) |
|---|
| NPIF-Morning | NPIF-Evening |
|---|
| Dupilumab 300 mg QW | 61.91 | 61.25 |
,| Placebo | 28.81 | 26.65 |
Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16
NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps. (NCT01920893)
Timeframe: Baseline, Week 16
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Week 16 | Change from baseline at Week 16 |
|---|
| Dupilumab 300 mg QW | 5.87 | 3.97 | -1.9 |
,| Placebo | 5.67 | 5.39 | -0.26 |
Time to First Response in NPS: Kaplan-Meier Estimate at Week 16
The time-to-first response in NPS: time from the date of randomization to the date of first NPS (defined as >=1 point reduction from baseline score); for participants without NPS >=1 point reduction, it was censored at the end of treatment date. The median time to first response was not estimated because the number of responses was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of response at Week 16, are presented as the descriptive measure statistics. (NCT01920893)
Timeframe: Baseline to Week 16
| Intervention | Probability of response (Number) |
|---|
| Placebo | 0.44 |
| Dupilumab 300 mg QW | 0.828 |
Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16
Severity of rhinosinusitis symptoms were assessed on a 0 cm (not troublesome) - 10 cm (worst thinkable troublesome) VAS where higher score indicated worst thinkable troublesome. (NCT01920893)
Timeframe: Baseline, Week 16
| Intervention | centimetre (cm) (Mean) |
|---|
| Placebo | -1.84 |
| Dupilumab 300 mg QW | -4.32 |
Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16
UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia)-40 (normal sense of smell), lower score indicated severe smell loss. (NCT01920893)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) |
|---|
| Placebo | -0.17 |
| Dupilumab 300 mg QW | 15.36 |
Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16
The SNOT-22 was a validated questionnaire to assess the impact of chronic rhinosinusitis on quality of life. The total score may range from 0 (no problem)-110 (worst quality of life), higher scores represented worst quality of life; minimal clinically important change ≥ 8.90. (NCT01920893)
Timeframe: Baseline, Week 16
| Intervention | score on a scale (Mean) |
|---|
| Placebo | -8.26 |
| Dupilumab 300 mg QW | -29.1 |
Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma
NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps. (NCT01920893)
Timeframe: Baseline, Week 16
| Intervention | score on a scale (Mean) |
|---|
| Placebo | 0.27 |
| Dupilumab 300 mg QW | -2.4 |
Overall Adherence to Dulera 100/5 and 200/5
"Subjects in the monitoring group will have adherence greater than or equal to the 60% benchmark~Overall interval value was the mean of daily percent" (NCT02045875)
Timeframe: 3 months
| Intervention | percent of prescribed doses per day (Mean) |
|---|
| Dulera Adherence Monitoring | 80.95 |
Adherence to Dulera 100/5 and 200/5
"Subjects in the monitoring group will have adherence greater than or equal to the 60% benchmark~Adherence was calculated by taking the number of doses actually taken divided by the number of doses prescribed and multiplying by 100." (NCT02045875)
Timeframe: week 2. months 1, 2, and 3
| Intervention | percent of prescribed doses (Mean) |
|---|
| week 2 | month 1 | month 2 | month 3 |
|---|
| Dulera Adherence Monitoring | 88.75 | 80.7 | 77.55 | 76.8 |
Asthma Control
Asthma Control Questionnaire measured at each office visit. ACQ integrates values by 6 clinical questions related to symptoms and the value related to FEV1% predicted with a total score ranging from 0-6 and higher values indicating poorer asthma control. (NCT02045875)
Timeframe: Baseline, one, two and three months
| Intervention | units on a scale (Mean) |
|---|
| baseline | one month | two month | three month |
|---|
| Dulera Adherence Monitoring | 1.857 | 1.792 | 1.345 | 1.105 |
,| Dulera Standard of Asthma Care | 1.592 | 1.578 | 1.488 | 1.407 |
Change in the Numerical Rating Scale (NRS) for Pain
Mean change in patient reported pain NRS score, full scale range 0- 10, higher score indicate more pain (NCT02061202)
Timeframe: baseline and 20 weeks
| Intervention | score on a scale (Mean) |
|---|
| Mometasone Furoate | 2.09 |
| Placebo | 2.82 |
Number of Participants Who Completed Follow up
Feasibility is determined by calculating the proportion of randomized participants who complete follow up and a minimum of 30 pain diaries with good adherence to the study medication vs. the number enrolled. (NCT02061202)
Timeframe: at 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Mometasone Furoate | 35 |
| Placebo | 17 |
Asthma Control Test
Asthma control test, total score from 0-25, with higher score indicating more symptoms (NCT02061202)
Timeframe: 8 weeks
| Intervention | score on a scale (Mean) |
|---|
| Mometasone Furoate | 17.7 |
| Placebo | 17.1 |
Change in Exhaled Nitric Oxide (eNO)
Change in effects of inhaled corticosteroids (ICS) as measured by exhaled nitric oxide levels, which is the primary marker of pulmonary inflammation. (NCT02061202)
Timeframe: Before ICS therapy begins and at 8 weeks post enrollment
| Intervention | ppb (Mean) |
|---|
| Mometasone Furoate | 0.63 |
| Placebo | 2.71 |
Change in FEV1/FVC
Mean change in FEV1/FVC at 8 weeks compared to baseline (NCT02061202)
Timeframe: baseline and 8 weeks
| Intervention | ratio (Mean) |
|---|
| Mometasone Furoate | -0.71 |
| Placebo | -1.41 |
Change in Reticulocytes Count
Mean change in reticulocytes count - the number of new red blood cells. (NCT02061202)
Timeframe: baseline and 8 weeks
| Intervention | 10^3 cells/μL (Mean) |
|---|
| Mometasone Furoate | -0.15 |
| Placebo | 0.07 |
Change in Soluble Vascular Cell Adhesion Molecule (sVCAM) Level
Mean Change in effects of inhaled corticosteroids vascular injury, assessed by biomarker sVCAM as a surrogate for vascular injury. (NCT02061202)
Timeframe: Before ICS therapy begins and at 8 weeks post enrollment
| Intervention | ng/mL (Mean) |
|---|
| Mometasone Furoate | -182.47 |
| Placebo | 170.25 |
The Medication Adherence Report Scale
The medication adherence report scale for asthma is a 10 question tool scored between 0 and 5, with full scale from 0 to 25, with higher scores indicating greater adherence (NCT02061202)
Timeframe: 20 weeks
| Intervention | score on a scale (Mean) |
|---|
| Mometasone Furoate | 17.7 |
| Placebo | 17.1 |
Admissions or Visits to the Hospital
Number of times participant visited the Emergency Department (ED) or was admitted to the hospital (NCT02061202)
Timeframe: baseline through 8 weeks
| Intervention | Events (Mean) |
|---|
| ED visits | Observation admits | Admissions |
|---|
| Mometasone Furoate | 0.97 | 0.37 | 0.37 |
,| Placebo | 1.12 | 0.59 | 0.47 |
Peak Expiratory Flow Rate
Peak expiratory flow rate is a person's maximum speed of expiration. It measures the airflow through the bronchi and thus the degree of obstruction in the airways. (NCT02066298)
Timeframe: End of 12-week treatment period
| Intervention | liters per minute (Mean) |
|---|
| Placebo | 476 |
| Mometasone 220mcg BID | 485 |
| Tiotropium Respimat 5mcg QD | 497 |
Treatment Failure
"Treatment Failure includes:~Awakening from asthma three or more times in a two-week period or on two consecutive nights, or~Using albuterol for relief of symptoms four or more times/day for two or more consecutive days, or~Albuterol has been relieving symptoms for less than four hours after each treatment over a 12-hour period, or~Using albuterol for relief of symptoms daily for seven days, and this use exceeds two times the weekly use of albuterol in the baseline period, or~exercise induces unusual breathlessness" (NCT02066298)
Timeframe: End of 12-week treatment period
| Intervention | Participants (Count of Participants) |
|---|
| Placebo | 29 |
| Mometasone 220mcg BID | 29 |
| Tiotropium Respimat 5mcg QD | 35 |
Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1.
This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of treatment failures. If one treatment results in no treatment failures and another treatment does, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by treatment failures, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response. (NCT02066298)
Timeframe: End of 12-week treatment period
| Intervention | Participants (Count of Participants) |
|---|
| Mometesone superior to placebo | Placebo superior to mometasone | Mometesone equal to placebo | Tiotropium superior to placebo | Placebo superior to tiotropium | Tiotropium equal to placebo |
|---|
| Eosinophil High | 35 | 12 | 20 | 25 | 19 | 18 |
,| Eosinophil Low | 74 | 56 | 46 | 80 | 52 | 49 |
Asthma Exacerbations
"Asthma exacerbations are more severe episodes of acute worsening, defined by meeting one or more of the following:~FEV1 <50% of baseline on 2 consecutive measurements~FEV1 <40% of predicted on 2 consecutive measurements~Use of ≥ 16 puffs of as needed β-agonist per 24 hours for a period of 48 hours~Use of oral/parenteral corticosteroid due to asthma" (NCT02066298)
Timeframe: End of 12-week treatment period
| Intervention | Participants (Count of Participants) |
|---|
| Placebo | 1 |
| Mometasone 220mcg BID | 3 |
| Tiotropium Respimat 5mcg QD | 5 |
Annualized Asthma Control Days
Asthma Control Days (ACD) are based on patient completed electronic daily diaries, and are defined as: A day with no rescue albuterol use (pre-exercise albuterol will not be counted), no non-study asthma medications, no daytime asthma symptoms (shortness of breath, wheezing, chest tightness, phlegm/mucus rated as mild, moderate or severe, or cough rated as moderate or severe), no nighttime asthma symptoms, no unscheduled healthcare visits for asthma, and no PEF < 80% of predetermined baseline. Annualized ACD are calculated as the proportion of ACD during the treatment period multiplied by 365. (NCT02066298)
Timeframe: End of 12-week treatment period
| Intervention | days (Mean) |
|---|
| Placebo | 179 |
| Mometasone 220mcg BID | 186 |
| Tiotropium Respimat 5mcg QD | 176 |
Forced Expiratory Volume at One Second (FEV1) Percent of Predicted
FEV1, expressed as percent of predicted FEV1 based on age, sex, race, and height. (NCT02066298)
Timeframe: End of 12-week treatment period
| Intervention | percentage of predicted FEV1 (Mean) |
|---|
| Eosinophil Low - Placebo | 92 |
| Mometasone 220mcg BID | 94 |
| Tiotropium Respimat 5mcg QD | 95 |
Ostial Patency
Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed) (NCT02228720)
Timeframe: Baseline, Day 30, Day 90
| Intervention | percentage of evaluable sinuses (Number) |
|---|
| Baseline - Frontal Sinuses | Day 30 - Frontal Sinuses | Day 90 - Frontal Sinuses | Baseline - Maxillary Sinuses | Day 30 - Maxillary Sinuses | Day 90 - Maxillary Sinuses |
|---|
| Propel Nova Sinus Implant | 33.3 | 100 | 88.2 | 57.1 | 100 | 94.1 |
Device Placement Success Rate
Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses. (NCT02228720)
Timeframe: Baseline Procedure
| Intervention | Percentage of attempted sinuses (Number) |
|---|
| Frontal Sinuses | Maxillary Sinuses |
|---|
| Propel Nova Sinus Implant | 100 | 95.2 |
Degree of Inflammation
Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes) (NCT02228720)
Timeframe: Baseline, Day 30, Day 90
| Intervention | units on a scale (Mean) |
|---|
| Baseline - Frontal Sinuses | Day 30 - Frontal Sinuses | Day 90 - Frontal Sinuses | Baseline - Maxillary Sinuses | Day 30 - Maxillary Sinuses | Day 90 - Maxillary Sinuses |
|---|
| Propel Nova Sinus Implant | 62.8 | 28.1 | 25.0 | 51.6 | 22.2 | 14.1 |
Adhesion/Scarring Grade 2 & 3
Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium) (NCT02228720)
Timeframe: Baseline, Day 30, Day 90
| Intervention | percentage of evaluable sinuses (Number) |
|---|
| Baseline - Frontal Sinuses | Day 30 - Frontal Sinuses | Day 90 - Frontal Sinuses | Baseline - Maxillary Sinuses | Day 30 - Maxillary Sinuses | Day 90 - Maxillary Sinuses |
|---|
| Propel Nova Sinus Implant | 33.4 | 4.5 | 11.8 | 19.1 | 0 | 5.3 |
Sino-Nasal Outcome Test (SNOT) 22
Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110 (NCT02228720)
Timeframe: Baseline, Day 30, Day 90
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 30 | Day 90 |
|---|
| Propel Nova Sinus Implant | 42.6 | 21.5 | 20.6 |
Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)
"The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.~Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)." (NCT02266810)
Timeframe: Day 30
| Intervention | percentage sinus requiring intervention (Number) |
|---|
| PROPEL Nova Sinus Implant | 11.5 |
| Sinus Surgery Only: Cohort 2 | 32.8 |
Occlusion/Restenosis (Propel Mini Cohort)
"Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows:~0=Patent~Restenosed/Partially Occluded~Occluded" (NCT02266810)
Timeframe: Day 30
| Intervention | percentage of evaluable sinuses (Number) |
|---|
| PROPEL Mini Sinus Implant | 21.1 |
| Sinus Surgery Only: Cohort 1 | 46.1 |
Need for Surgical Interventions (Propel Nova Cohort)
"Need for Surgical Interventions by clinical investigators at Day 30~Need for Surgical Interventions by clinical investigators at Day 30.~Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.~Adhesions/Scarring was assessed based on a 4-point scale as follows:~0= No visible granulation/scarring in the FSO~Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)~Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)~Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)" (NCT02266810)
Timeframe: Day 30
| Intervention | percentage of evaluable sinuses (Number) |
|---|
| PROPEL Nova Sinus Implant | 4.0 |
| Sinus Surgery Only: Cohort 2 | 14.7 |
Need for Surgical Interventions (Propel Mini Cohort)
"Need for Surgical Interventions by clinical investigators at Day 30.~Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.~Adhesions/Scarring was assessed based on a 4-point scale as follows:~0= No visible granulation/scarring in the FSO~Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)~Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)~Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)" (NCT02266810)
Timeframe: Day 30
| Intervention | percentage of evaluable sinuses (Number) |
|---|
| PROPEL Mini Sinus Implant | 4.0 |
| Sinus Surgery Only: Cohort 1 | 16.0 |
Occlusion/Restenosis (Propel Nova Cohort)
"Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows:~0=Patent~Restenosed/Partially Occluded~Occluded" (NCT02266810)
Timeframe: Day 30
| Intervention | percentage of evaluable sinuses (Number) |
|---|
| PROPEL Nova Sinus Implant | 13.3 |
| Sinus Surgery Only: Cohort 2 | 36.0 |
Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)
"The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.~Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)." (NCT02266810)
Timeframe: Day 30
| Intervention | percent sinuses requiring intervention (Number) |
|---|
| PROPEL Mini Sinus Implant | 38.8 |
| Sinus Surgery Only: Cohort 1 | 62.7 |
Need for Post-operative Interventions (Propel Nova Cohort)
"Need for post-operative interventions by clinical investigators at Day 30.~Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale by investigators), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)." (NCT02266810)
Timeframe: Day 30
| Intervention | percentage of evaluable sinuses (Number) |
|---|
| PROPEL Nova Sinus Implant | 16.0 |
| Sinus Surgery Only: Cohort 2 | 33.3 |
Inflammation (Propel Mini Cohort)
The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis. (NCT02266810)
Timeframe: Day 30
| Intervention | 100-mm VAS (Mean) |
|---|
| PROPEL Mini Sinus Implant | 24.7 |
| Sinus Surgery Alone: Cohort 1 | 41.3 |
Need for Post-operative Interventions (Propel Mini Cohort)
"Need for post-operative interventions by clinical investigators at Day 30~Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)." (NCT02266810)
Timeframe: Day 30
| Intervention | percentage of evaluable sinuses (Number) |
|---|
| PROPEL Mini Sinus Implant | 16.5 |
| Sinus Surgery Only: Cohort 1 | 41.8 |
Inflammation (Propel Nova Cohort)
The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis. (NCT02266810)
Timeframe: Day 30
| Intervention | 100-mm VAS (Mean) |
|---|
| PROPEL Nova Sinus Implant | 23.1 |
| Sinus Surgery Alone: Cohort 2 | 35.6 |
Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS)
Proportion of patients still indicated for RESS at day 90 despite ongoing use of mometasone furoate nasal spray based on clinical investigator assessment using study-specific criteria. To be indicated for RESS, patients had to: (1) complain of nasal obstruction/congestion (moderate to severe) and postnasal discharge, facial pain/pressure/fullness, or altered sense of smell/taste; (2) have endoscopic evidence of persisting nasal polyps (grade >= 2 on each side); and (3) have received (required at baseline) or need a systemic steroid as noted during endoscopy. (NCT02291549)
Timeframe: Day 90
| Intervention | Participants (Count of Participants) |
|---|
| Baseline | Day 90 |
|---|
| Control | 99 | 62 |
,| Treatment | 201 | 78 |
Nasal Obstruction/Congestion Score
Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to the baseline and Day 30 visits. Negative values for change from baseline indicate reduction (improvement) in nasal obstruction/congestion symptoms. (NCT02291549)
Timeframe: Day 30
| Intervention | units on a scale (Mean) |
|---|
| Baseline | 30 Day | Change from baseline |
|---|
| Control | 2.35 | 1.79 | -0.56 |
,| Treatment | 2.36 | 1.56 | -0.80 |
Bilateral Polyp Grade
Polyp grade was determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicated reduction (improvement) in bilateral polyp grade. (NCT02291549)
Timeframe: Day 90
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 90 | Change from baseline |
|---|
| Control | 5.43 | 5.26 | -0.15 |
,| Treatment | 5.48 | 4.91 | -0.56 |
Ethmoid Sinus Obstruction
Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline indicated reduction (improvement) in ethmoid sinus obstruction. (NCT02291549)
Timeframe: Day 90
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 90 | Change from baseline |
|---|
| Control | 67.0 | 64.8 | -1.9 |
,| Treatment | 69.2 | 57.7 | -11.3 |
Decreased Sense of Smell Score
Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in sense of smell. (NCT02291549)
Timeframe: Day 90
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 90 | Change from baseline |
|---|
| Control | 4.1 | 3.4 | -0.76 |
,| Treatment | 4.1 | 2.9 | -1.20 |
Facial Pain/Pressure Score
Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in facial pain/pressure symptoms. (NCT02291549)
Timeframe: Day 90
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 90 | Change from baseline |
|---|
| Control | 2.2 | 1.2 | -0.90 |
,| Treatment | 1.9 | 1.1 | -0.77 |
Nasal Obstruction/Congestion Score
Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to baseline and Day 90. Negative values for change from baseline indicated reduction (improvement) in nasal obstruction/congestion symptoms. (NCT02291549)
Timeframe: Day 90
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Day 90 | Change from baseline |
|---|
| Control | 2.35 | 1.68 | -0.69 |
,| Treatment | 2.36 | 1.42 | -0.93 |
Change in rTNSS From Baseline to End of Treatment
"Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching.~The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome.~The severity scale for each symptom evaluation was defined as follows:~0 = absent (no sign/symptom evident)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate [i.e., causes interference with activities of daily living and/or sleeping])" (NCT02318303)
Timeframe: 14 days
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change from Baseline to Visit 4 |
|---|
| GSP 301 Placebo | 10.3 | -1.4 |
,| GSP 301-1 NS (QD) | 10.4 | -2.5 |
,| GSP 301-2 NS (BID) | 10.4 | -2.6 |
,| Mometasone Furoate-1 NS (QD) | 10.4 | -2.2 |
,| Mometasone Furoate-2 NS (BID) | 10.5 | -1.9 |
,| Olopatadine HCl-1 NS (QD) | 10.3 | -1.7 |
,| Olopatadine HCl-2 NS (BID) | 10.3 | -2.1 |
Percentage of Participants Reporting Anaphylaxis and/or Systemic Allergic Reactions
For the purposes of this study, systemic allergic reactions are allergic reactions that occur away from the site of study drug application (allergic reactions other than local application site reactions). Anaphylaxis is a severe allergic reaction that typically involves more than one body system. (NCT02478398)
Timeframe: Up to 35 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Short Ragweed Pollen Allergen Extract | 0.58 |
| Placebo | 0.20 |
Average TCS During the Entire RS
TCS is DSS plus DMS, assessed here during the entire RS. This starts from the first day of 3 consecutive days with ragweed pollen counts ≥10 grains/m^3 through the last day of the last occurrence of 3 consecutive days with ragweed pollen counts ≥10 grains/m^3. The duration of the entire RS is up to 13 weeks; this duration varies by site/region. The RC DSS assesses 6 allergy symptoms measured on a scale of 0 to 3 (score range: 0-18). A lower DSS indicates less RC symptoms. The RC DMS is based on use of RC rescue medications (loratadine, olopatadine, mometasone) with different scores/dose unit (score range: 0-20). A lower DMS indicates less RC medication use. The sum of RC DSS+DMS ranges from 0 to 38, with a lower score indicating less RC symptoms and medication use. Components contributing to the TCS for the entire RS are collected in an e-diary completed by the participant/parent/guardian. (NCT02478398)
Timeframe: Up to 13 weeks
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Short Ragweed Pollen Allergen Extract | 3.88 |
| Placebo | 5.75 |
Percentage of Participants Reporting Pre-specified Local Application Site Reactions
Pre-specified local application site reactions, irrespective of causality, included AEs related to lip swelling/edema, mouth swelling/edema, palatal swelling/edema, swollen tongue/edema, oropharyngeal swelling/edema, pharyngeal edema/throat tightness, oral pruritus, throat irritation, tongue pruritus, and ear pruritus. (NCT02478398)
Timeframe: Up to 35 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Short Ragween Pollen Allergen Extract | 64.52 |
| Placebo | 26.92 |
Average Rhinoconjunctivitis (RC) DMS During the Peak RS
This DMS endpoint consists of a total of scores for use of RC medications: loratadine syrup or tablets (6 points), olopatadine (6 points), and mometasone (8 points). The score range of the RC DMS is 0-20 points, and a lower DMS means that less medication is used. The method used for analysis of the RC DMS is a zero-inflated log-normal model, which takes the average RC DMS during the peak RS as the response and adjusts for the same terms as in the ANOVA model. The components that contribute to the DMS endpoint are collected in an e-diary completed by the participant/parent/guardian. (NCT02478398)
Timeframe: The 15-day period during the ragweed season with the highest moving pollen average
| Intervention | Score on a scale (Mean) |
|---|
| Short Ragweed Pollen Allergen Extract | 2.01 |
| Placebo | 3.85 |
Total Combined Score (TCS) During the Peak Ragweed Season (RS)
TCS is daily symptom score (DSS) plus daily medication score (DMS), assessed in the peak RS (15 consecutive RS days with the highest 15-day average pollen count). The rhinoconjunctivitis (RC) DSS assesses 6 allergy symptoms measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Lower DSS indicates less RC symptoms. The RC DMS is based on use of RC rescue medications (loratadine, olopatadine, mometasone), with different rescue medications being assigned different scores/dose unit (score range: 0-20). Lower DMS indicates less RC medication use. Summed RC DSS+DMS could range from 0 to 38; a lower score indicates less RC symptoms and medication use. Components that contribute to DSS and DMS endpoints are collected in an electronic diary (e-diary) completed by the participant/parent/guardian. Evaluation is based on average TCS during peak RS. (NCT02478398)
Timeframe: The 15-day period during the ragweed season with the highest moving pollen average
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Short Ragweed Pollen Allergen Extract | 4.39 |
| Placebo | 7.12 |
Percentage of Participants Treated With Epinephrine
Self-injectable epinephrine was provided to each participant/parent/guardian at randomization in countries where it is a regulatory requirement, and was to be available around the time treatment is administered at home. Self-injectable epinephrine was intended for immediate self-administration for an anaphylactic reaction, including symptoms/signs of upper airway obstruction. Instances of treatment with forms of epinephrine other than systemic epinephrine (e.g., inhaled racepinephrine) were counted as use of epinephrine. (NCT02478398)
Timeframe: Up to 35 weeks
| Intervention | Percentage of Participants (Number) |
|---|
| Short Ragween Pollen Allergen Extract | 0.19 |
| Placebo | 0.20 |
Average Rhinoconjunctivitis (RC) DSS During the Peak RS
The DSS consists of a total of 6 rhinoconjunctivitis symptoms: 4 rhinitis symptoms (runny nose, stuffy nose, sneezing, itchy nose) and 2 conjunctivitis symptoms (itchy eyes, watery eyes). The components that contribute to the DSS endpoint are collected in an e-diary completed by the participant/parent/guardian. The RC DSS is measured on a 4-point scale from 0 to 3 as follows: 0 (no sign/symptom evident) to 3 (sign/symptom that is hard to tolerate; may cause interference with activities of daily living and/or sleeping). The maximum DSS is 18 points if a participant experiences all 6 symptoms with an intensity of 3 for each symptom. The minimum DSS is 0 points if a participant experiences no symptoms. A lower DSS means symptoms are less severe. The evaluation is based on the average DSS during the peak RS. (NCT02478398)
Timeframe: The 15-day period during the ragweed season with the highest moving pollen average
| Intervention | Score on a scale (Least Squares Mean) |
|---|
| Short Ragweed Pollen Allergen Extract | 2.55 |
| Placebo | 3.95 |
Post Dose FEV1 (5 Minutes-1 Hour)
Post-dose FEV1 measurements were analyzed at 5 minutes, 15 minutes, 30 minutes and 1 hour. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. (NCT02554786)
Timeframe: Up to Week 52 (Day 364)
| Intervention | L (Least Squares Mean) |
|---|
| Day 1: 5 minutes | Day 1: 15 minutes | Day 1: 30 minutes | Day 1: 1 hour | Day 30: 5 minutes | Day 30: 30 minutes | Day 30: 1 hour | Day 86:5 minutes | Day 86: 30 minutes | Day 86:1 hour | Day 183: 5 minutes | Day 183: 30 minutes | Day 183: 1 hour | Day 364: 5 minutes | Day 364: 30 minutes | Day 364:1 hour |
|---|
| MF 400 μg | 2.118 | 2.137 | 2.141 | 2.142 | 2.174 | 2.174 | 2.183 | 2.178 | 2.179 | 2.188 | 2.163 | 2.168 | 2.165 | 2.130 | 2.135 | 2.128 |
,| MF 800 μg | 2.138 | 2.159 | 2.162 | 2.166 | 2.224 | 2.238 | 2.257 | 2.248 | 2.257 | 2.269 | 2.240 | 2.250 | 2.253 | 2.245 | 2.253 | 2.251 |
,| QMF149 150/160 μg | 2.270 | 2.312 | 2.326 | 2.347 | 2.406 | 2.426 | 2.440 | 2.409 | 2.431 | 2.436 | 2.406 | 2.427 | 2.423 | 2.379 | 2.399 | 2.390 |
,| QMF149 150/320 μg | 2.279 | 2.321 | 2.338 | 2.343 | 2.413 | 2.432 | 2.448 | 2.411 | 2.436 | 2.456 | 2.403 | 2.426 | 2.432 | 2.384 | 2.408 | 2.414 |
,| Salmeterol/Fluticasone 50/500 μg | 2.224 | 2.278 | 2.310 | 2.337 | 2.360 | 2.389 | 2.411 | 2.356 | 2.398 | 2.413 | 2.359 | 2.386 | 2.393 | 2.358 | 2.377 | 2.383 |
Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. (NCT02554786)
Timeframe: Up to Week 52
| Intervention | percentage of participants (Number) |
|---|
| Moderate or severe asthma exacerbation | Severe asthma exacerbation | Moderate asthma exacerbation | Mild asthma exacerbation | All (mild, moderate, severe) asthma exacerbation |
|---|
| MF 400 μg | 32.5 | 20.1 | 16.5 | 19.6 | 44.5 |
,| MF 800 μg | 26.1 | 14.5 | 14.3 | 17.5 | 36.1 |
,| QMF149 150/160 μg | 16.9 | 9.8 | 8.2 | 12.1 | 25.6 |
,| QMF149 150/320 μg | 14.9 | 8.1 | 7.7 | 13.3 | 25.5 |
,| Salmeterol/Fluticasone 50/500 μg | 19.1 | 11.9 | 9.2 | 15.1 | 30.6 |
Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
An AE is any untoward medical occurrence (i.e., any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. An SAE is defined as any adverse event (appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s) or medical conditions(s) which meets any one of the following criteria: is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant, i.e. defined as an event that jeopardizes the participants or may require medical or surgical intervention. (NCT02554786)
Timeframe: Approximately up to 56 weeks
| Intervention | percentage of participants (Number) |
|---|
| Adverse Events(AEs) | Serious Adverse Events(SAEs) |
|---|
| MF 400 μg | 72.2 | 7.0 |
,| MF 800 μg | 70.0 | 4.8 |
,| QMF149 150/160 μg | 66.8 | 4.6 |
,| QMF149 150/320 μg | 64.6 | 4.7 |
,| Salmeterol/Fluticasone 50/500 μg | 65.3 | 4.7 |
Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52
Change from baseline in ACQ-7 scores of ≤ 0.5 was defined as minimal clinically important difference and were considered clinically meaningful. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions (NCT02554786)
Timeframe: Weeks 26 (Day 183) and 52 (Day 364)
| Intervention | percentage of participants (Number) |
|---|
| Day 183 | Day 364 |
|---|
| MF 400 μg | 66.9 | 69.2 |
,| MF 800 μg | 72.3 | 73.6 |
,| QMF149 150/160 μg | 76.2 | 82.1 |
,| QMF149 150/320 μg | 76.4 | 77.7 |
,| Salmeterol/Fluticasone 50/500 μg | 75.9 | 77.3 |
Duration in Days of Asthma Exacerbations by Exacerbation Category
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. (NCT02554786)
Timeframe: Up to Week 52
| Intervention | days (Mean) |
|---|
| Moderate or severe asthma exacerbation | Severe asthma exacerbation | All(mild, moderate,severe) asthma exacerbation |
|---|
| MF 400 μg | 5.8 | 3.2 | 10.1 |
,| MF 800 μg | 3.7 | 1.7 | 6.9 |
,| QMF149 150/160 μg | 3.0 | 1.7 | 5.0 |
,| QMF149 150/320 μg | 2.6 | 1.3 | 5.4 |
,| Salmeterol/Fluticasone 50/500 μg | 3.1 | 1.9 | 5.1 |
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment
PEF is a person's maximum speed of expiration. All the participants were instructed to record PEF twice daily using a mini Peak Flow Meter device, once in the morning (before taking the morning dose) and once approximately 12 h later in the evening (before taking the evening dose). At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the e-PEF/diary. The best of 3 values were used. (NCT02554786)
Timeframe: Up to Weeks 26 and 52
| Intervention | L/min (Least Squares Mean) |
|---|
| Week 26: Mean morning PEF | Week 26:Mean evening PEF | Week 52:Mean morning PEF | Week 52:Mean evening PEF |
|---|
| MF 400 μg | 5.9 | 0.0 | 6.7 | -0.3 |
,| MF 800 μg | 12.8 | 7.7 | 13.4 | 7.4 |
,| QMF149 150/160 μg | 38.1 | 30.4 | 36.9 | 28.7 |
,| QMF149 150/320 μg | 42.4 | 32.5 | 42.1 | 31.2 |
,| Salmeterol/Fluticasone 50/500 μg | 29.1 | 23.9 | 28.3 | 22.1 |
Asthma Quality of Life Questionnaire (AQLQ)
"AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). It consists of 4 domains:~Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items)~Activity limitation = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items)~Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items)~Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items)~Overall Score = Mean of Items 1 to 32 (32 items)" (NCT02554786)
Timeframe: Up to Week 52 (Day 364)
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Day 30 | Day 86 | Day 183 | Day 254 | Day 364 |
|---|
| MF 400 μg | 5.374 | 5.510 | 5.581 | 5.614 | 5.641 |
,| MF 800 μg | 5.413 | 5.564 | 5.598 | 5.689 | 5.705 |
,| QMF149 150/160 μg | 5.498 | 5.629 | 5.738 | 5.781 | 5.832 |
,| QMF149 150/320 μg | 5.560 | 5.618 | 5.724 | 5.761 | 5.783 |
,| Salmeterol/Fluticasone 50/500 μg | 5.515 | 5.592 | 5.639 | 5.700 | 5.742 |
Change From Baseline in Percentage of Asthma Symptoms Free Days
All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. Asthma symptoms free days are days with no daytime symptoms, no night-time awakenings and no symptoms on awakening. The daytime asthma symptom score was based on the daily e-diary recordings by participants with respect to shortness of breath, wheeze, cough, chest tightness, and impact on usual daily activities due to symptoms. (NCT02554786)
Timeframe: Up to Week 52
| Intervention | percentage of days (Least Squares Mean) |
|---|
| QMF149 150/320 μg | 28.3 |
| QMF149 150/160 μg | 28.4 |
| MF 800 μg | 22.5 |
| MF 400 μg | 19.3 |
| Salmeterol/Fluticasone 50/500 μg | 24.9 |
Change From Baseline in Percentage of Nights With no Night-time Awakenings
"All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was How did you sleep last night? had to be answered with I did not wake up because of any breathing problems with scores from 0 (no problem)-4 (very severe problems)." (NCT02554786)
Timeframe: Up to Week 52
| Intervention | percentage of nights (Least Squares Mean) |
|---|
| QMF149 150/320 μg | 17.0 |
| QMF149 150/160 μg | 16.4 |
| MF 800 μg | 14.2 |
| MF 400 μg | 12.5 |
| Salmeterol/Fluticasone 50/500 μg | 16.1 |
Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations
(NCT02554786)
Timeframe: Up to Week 52
| Intervention | percentage of participants (Number) |
|---|
| QMF149 150/320 μg | 0.2 |
| QMF149 150/160 μg | 0 |
| MF 800 μg | 0.9 |
| MF 400 μg | 1.6 |
| Salmeterol/Fluticasone 50/500 μg | 0.5 |
Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes
A composite endpoint of serious asthma outcomes is defined as asthma-related hospitalization, asthma-related intubation, or asthma-related death and was reviewed by the Adjudication Committee. (NCT02554786)
Timeframe: Up to Week 52
| Intervention | percentage of participants (Number) |
|---|
| QMF149 150/320 μg | 0.7 |
| QMF149 150/160 μg | 0.5 |
| MF 800 μg | 1.6 |
| MF 400 μg | 1.8 |
| Salmeterol/Fluticasone 50/500 μg | 0.5 |
Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. (NCT02554786)
Timeframe: Up to Week 52
| Intervention | days (Median) |
|---|
| QMF149 150/320 μg | 367.0 |
| QMF149 150/160 μg | 367.0 |
| MF 800 μg | 367.0 |
| MF 400 μg | 366.0 |
| Salmeterol /Fluticasone 50/500 μg | 367.0 |
Time to First Hospitalization for Asthma Exacerbation
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. (NCT02554786)
Timeframe: Up to Week 52
| Intervention | days (Median) |
|---|
| QMF149 150/320 μg | 367.0 |
| QMF149 150/160 μg | 367.0 |
| MF 800 μg | 367.0 |
| MF 400 μg | 366.0 |
| Salmeterol/Fluticasone 50/500 μg | 367.0 |
Total Amounts of Systemic Corticosteroids (in Doses) Used to Treat Asthma Exacerbations
The treatment of asthma exacerbations including the initiation of systemic corticosteroids were done according to investigator's or treating physician's medical judgement and in line with national and international recommendations. If systemic corticosteroids were required, a participant could return to the study after successfully completing a taper of approximately 7-10 days. (NCT02554786)
Timeframe: Up to Week 52
| Intervention | milligrams (Mean) |
|---|
| QMF149 150/320 μg | 26.0 |
| QMF149 150/160 μg | 29.9 |
| MF 800 μg | 28.0 |
| MF 400 μg | 47.8 |
| Salmeterol/Fluticasone 50/500 μg | 26.9 |
Trough FEV1 at Week 52
Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. (NCT02554786)
Timeframe: Week 52
| Intervention | L (Least Squares Mean) |
|---|
| QMF149 150/320 μg | 2.386 |
| QMF149 150/160 μg | 2.357 |
| MF 800 μg | 2.249 |
| MF 400 μg | 2.148 |
| Salmeterol/Fluticasone 50/500 μg | 2.338 |
Trough FEV1 Measured After 26 Weeks of Treatment
Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. (NCT02554786)
Timeframe: Week 26
| Intervention | L (Least Squares Mean) |
|---|
| QMF149 150/320 μg | 2.383 |
| QMF149 150/160 μg | 2.387 |
| MF 800 μg | 2.250 |
| MF 400 μg | 2.176 |
| Salmeterol/Fluticasone 50/500 μg | 2.346 |
Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52
The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions. (NCT02554786)
Timeframe: Weeks 4, 12, 26 and 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Week 4 | Week 12 | Week 26 | Week 52 |
|---|
| MF 400 μg | 1.730 | 1.625 | 1.509 | 1.449 |
,| MF 800 μg | 1.659 | 1.523 | 1.439 | 1.373 |
,| QMF149 150/160 μg | 1.533 | 1.377 | 1.261 | 1.183 |
,| QMF149 150/320 μg | 1.486 | 1.394 | 1.267 | 1.231 |
,| Salmeterol/Fluticasone 50/500 μg | 1.541 | 1.445 | 1.322 | 1.221 |
Annual Rate of Asthma Exacerbations by Exacerbation Category
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. (NCT02554786)
Timeframe: Up to Week 52
| Intervention | exacerbations per year (Mean) |
|---|
| Moderate or severe asthma exacerbation | Severe asthma exacerbation | All (mild, moderate, severe) asthma exacerbation |
|---|
| MF 400 μg | 0.56 | 0.29 | 1.05 |
,| MF 800 μg | 0.39 | 0.18 | 0.74 |
,| QMF149 150/160 μg | 0.27 | 0.13 | 0.48 |
,| QMF149 150/320 μg | 0.25 | 0.13 | 0.49 |
,| Salmeterol/Fluticasone 50/500 μg | 0.27 | 0.14 | 0.52 |
Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26
Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. (NCT02554786)
Timeframe: 26 weeks
| Intervention | litre (L) (Least Squares Mean) |
|---|
| QMF149 150/320 μg | 2.383 |
| QMF149 150/160 μg | 2.387 |
| MF 800 μg | 2.250 |
| MF 400 μg | 2.176 |
| Salmeterol/Fluticasone 50/500 μg | 2.346 |
Change From Baseline in Percentage of Rescue Medication Free Days
All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. Rescue medication free days is defined as any day where the participant did not use any puffs of rescue medication during daytime and night-time. (NCT02554786)
Timeframe: Up to Weeks 26 and 52
| Intervention | percentage of days (Least Squares Mean) |
|---|
| Weeks 1-26 | Weeks 1-52 |
|---|
| MF 400 μg | 19.1 | 20.8 |
,| MF 800 μg | 21.4 | 23.5 |
,| QMF149 150/160 μg | 27.4 | 29.4 |
,| QMF149 150/320 μg | 31.5 | 33.1 |
,| Salmeterol /Fluticasone 50/500 μg | 27.4 | 28.8 |
Trough Forced Vital Capacity (FVC)
FVC is the total amount of air exhaled during the FEV test. Trough FVC is defined as average of the two FVC measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment. (NCT02554786)
Timeframe: Up to Week 52 (Day 365)
| Intervention | L (Least Squares Mean) |
|---|
| Day 2 | Day 184 | Day 365 |
|---|
| MF 400 μg | 3.203 | 3.246 | 3.218 |
,| MF 800 μg | 3.256 | 3.322 | 3.319 |
,| QMF149 150/160 μg | 3.342 | 3.387 | 3.364 |
,| QMF149 150/320 μg | 3.342 | 3.372 | 3.394 |
,| Salmeterol/Fluticasone 50/500 μg | 3.344 | 3.355 | 3.358 |
Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75)
FEF is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Trough FEF25-75% is defined as average of the two FEF25-75% measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment. (NCT02554786)
Timeframe: Up to Week 52 (Day 365)
| Intervention | Litres/second (L/s) (Least Squares Mean) |
|---|
| Day 2 | Day 184 | Day 365 |
|---|
| MF 400 μg | 1.406 | 1.473 | 1.440 |
,| MF 800 μg | 1.455 | 1.546 | 1.530 |
,| QMF149 150/160 μg | 1.617 | 1.738 | 1.686 |
,| QMF149 150/320 μg | 1.644 | 1.775 | 1.745 |
,| Salmeterol/Fluticasone 50/500 μg | 1.662 | 1.692 | 1.692 |
Time to First Asthma Exacerbation by Exacerbation Category
The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe. (NCT02554786)
Timeframe: Up to Week 52
| Intervention | days (Median) |
|---|
| Moderate or severe asthma exacerbation | Severe asthma exacerbation | All (mild, moderate or severe) asthma exacerbation |
|---|
| MF 400 μg | 364.0 | 366 | 306.0 |
,| MF 800 μg | 366.0 | 366 | 364.5 |
,| QMF149 150/160 μg | 366.0 | 366 | 366.0 |
,| QMF149 150/320 μg | 366.0 | 367 | 366.0 |
,| Salmeterol/Fluticasone 50/500 μg | 366.0 | 366 | 365.0 |
Rescue Medication Usage
All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. The number of puffs of rescue medication during the past 12 hours is recorded twice (morning/evening) by the participant prior to taking study medication. The mean daily number of puffs of rescue medication use will be calculated for each participant, done separately for morning (night-time), evening (daytime), and daily (night-time plus daytime) rescue medication use (NCT02554786)
Timeframe: Up to Weeks 26 and 52
| Intervention | number of puffs (Least Squares Mean) |
|---|
| Week1-26 Mean night-time number of puffs | Week1-26 Mean daytime number of puffs | Week1-26 Mean daily number of puffs | Week1-52 Mean night-time number of puffs | Week 1-52 Mean daytime number of puffs | Week 1-52 Mean daily number of puffs |
|---|
| MF 400 μg | -0.19 | -0.34 | -0.53 | -0.20 | -0.36 | -0.56 |
,| MF 800 μg | -0.26 | -0.38 | -0.65 | -0.29 | -0.43 | -0.72 |
,| QMF149 150/160 μg | -0.27 | -0.46 | -0.73 | -0.30 | -0.51 | -0.80 |
,| QMF149 150/320 μg | -0.38 | -0.57 | -0.96 | -0.40 | -0.60 | -1.00 |
,| Salmeterol/Fluticasone 50/500 μg | -0.34 | -0.53 | -0.87 | -0.35 | -0.55 | -0.91 |
Pre-dose FEV1 at Weeks 4 and 12
Pre-dose trough FEV1 is defined as average of the two FEV1 measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. (NCT02554786)
Timeframe: Weeks 4 (Day 30) and 12 (Day 86)
| Intervention | L (Least Squares Mean) |
|---|
| Day 30 | Day 86 |
|---|
| MF 400 μg | 2.171 | 2.177 |
,| MF 800 μg | 2.237 | 2.245 |
,| QMF149 150/160 μg | 2.367 | 2.361 |
,| QMF149 150/320 μg | 2.369 | 2.368 |
,| Salmeterol /Fluticasone 50/500 μg | 0.2333 | 2.330 |
Change From Baseline in Mast Cells Count (Tryptase Positive) in the Bronchial Submucosa at Week 12
Inflammatory cells i.e. mast cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter. (NCT02573233)
Timeframe: Baseline, Week 12
| Intervention | cells/mm^2 (Mean) |
|---|
| Placebo | 2.37 |
| Dupilumab | -20.89 |
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during between the first administration of study medication to the end of the 12 week Post-treatment Period. Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included both serious and non-serious AEs. (NCT02573233)
Timeframe: Baseline up to Week 24
| Intervention | Participants (Count of Participants) |
|---|
| Any TEAE | Any treatment emergent SAE | Any TEAE leading to death | Any TEAE leading to permanent discontinuation |
|---|
| Dupilumab | 15 | 1 | 0 | 0 |
,| Placebo | 17 | 0 | 0 | 0 |
Pharmacokinetics (PK) Assessment: Serum Functional Dupilumab Concentration
Serum functional dupilumab concentrations were determined using an enzyme-linked immunosorbent assay (ELISA) method. (NCT02573233)
Timeframe: Week 0, Week 2, 6, 8, 12, 18, End of study (Week 24)
| Intervention | ng/mL (Mean) |
|---|
| Week 0 | Week 2 | Week 6 | Week 8 | Week 12 | Week 18 | Week 24 |
|---|
| Dupilumab | 0.00 | 52675.00 | 59969.00 | 61097.95 | 67387.00 | 20728.17 | 1851.20 |
Change From Baseline in Mucin-Stained Area in the Bronchial Submucosa at Week 12
Mucin was identified by staining with Alcian-blue periodic acid-Schiff and/or immunostaining for MUC5AC and then the mucin-positive area was measured and expressed per square millimeter. (NCT02573233)
Timeframe: Baseline, Week 12
| Intervention | cells/mm^2 (Mean) |
|---|
| Placebo | 64.09 |
| Dupilumab | -142.74 |
Change From Baseline in T-Helper Lymphocytes Count in the Bronchial Submucosa at Week 12
T-helper i.e. CD4 positive lymphocytes were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter. (NCT02573233)
Timeframe: Baseline, Week 12
| Intervention | cells/mm^2 (Median) |
|---|
| Placebo | 7.26 |
| Dupilumab | 62.34 |
Change From Baseline in T-Lymphocytes Count in the Bronchial Submucosa at Week 12
T-Lymphocytes i.e. CD3 positive cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter. (NCT02573233)
Timeframe: Baseline, Week 12
| Intervention | cells/mm^2 (Median) |
|---|
| Placebo | -36.70 |
| Dupilumab | 34.21 |
Average Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 6 Through Week 12
"FeNO is a surrogate marker for airway inflammation. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/s, and reported in ppb.~The average change in FeNO from baseline to Week 6 through Week 12 was calculated as follows: For each participant the change in FeNO from Baseline to Week 6, Week 8, Week 10 and Week 12 was calculated (value at Week X - value at baseline). Subsequently the weekly mean of these 4 change from baseline values was determined (Weeks 6, 8, 10 and 12). Using these weekly mean values the overall arithmetic mean and standard deviation of the average change in FeNO from baseline to Week 6 through Week 12 was calculated." (NCT02573233)
Timeframe: From Baseline to Week 6 through Week 12
| Intervention | ppb (Mean) |
|---|
| Placebo | 3.5 |
| Dupilumab | -16.0 |
Change From Baseline in Eosinophils Cells Count in the Bronchial Submucosa at Week 12
Inflammatory cells i.e. eosinophils were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter. (NCT02573233)
Timeframe: Baseline, Week 12
| Intervention | cells/mm^2 (Median) |
|---|
| Placebo | 5.80 |
| Dupilumab | -6.04 |
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 12
FeNO is a surrogate marker for airway inflammation. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/second, and reported in ppb. (NCT02573233)
Timeframe: Baseline, Week 12
| Intervention | ppb (Mean) |
|---|
| Placebo | 3.9 |
| Dupilumab | -15.1 |
Change From Baseline in Mast Cells Count (Chymase Positive) in the Bronchial Submucosa at Week 12
Inflammatory cells i.e. mast cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter. (NCT02573233)
Timeframe: Baseline, Week 12
| Intervention | cells/mm^2 (Mean) |
|---|
| Placebo | -14.80 |
| Dupilumab | 1.76 |
Number of Participants With Antidrug Antibodies (ADA)
Anti-drug antibodies were detected using a validated immunoassay. Incidence of ADA were classified as following: 1) Pre-existing immunoreactivity - an ADA positive response in the assay at baseline with all post treatment ADA results negative or an ADA positive response at baseline with all post treatment ADA responses less than 4-fold over baseline titer levels. 2) Treatment-emergent ADA: an ADA positive response in the assay post first dose, when baseline results were negative or missing. 3) Treatment-boosted ADA: an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive. (NCT02573233)
Timeframe: From Baseline up to 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| With pre-existing immunoreactivity | With treatment-emergent ADA | With treatment-boosted ADA |
|---|
| Dupilumab | 0 | 1 | 0 |
,| Placebo | 1 | 0 | 0 |
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate). (NCT02631551)
Timeframe: 14 days
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change from baseline to end of treatment |
|---|
| GSP 301 NS | 10.1 | -3.6 |
,| GSP 301 Placebo NS | 10.2 | -2.8 |
,| Mometasone Furoate NS | 10.2 | -3.5 |
,| Olopatadine HCl NS | 10.3 | -3.2 |
Mean Change From Baseline in Total Daily Use of Short-Acting Beta-Agonist (SABA) Rescue Medication With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment
To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the change from baseline in total daily short-acting beta-agonist (SABA) use (puffs per day) was averaged and assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for as-needed relief of asthma symptoms. This secondary analysis of the change from baseline used the cLDA method without multiple imputation.A model-based MAR approach was used for missing data. (NCT02741271)
Timeframe: Baseline and Weeks 1-12 (Averaged)
| Intervention | Puffs per day (Mean) |
|---|
| Baseline | Change from Baseline Over Weeks 1-12 (Average) |
|---|
| MF MDI 100 mcg BID | 0.13 | -0.02 |
,| MF/F MDI 100/10 mcg BID | 0.25 | -0.12 |
Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60
This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 60 minutes post-dose (at 0, 5, 15, 30 and 60 minutes) and averaged across study visits in the Treatment Period (Day 1, Week 1, Week 4, Week 8 and Week 12) compared to Baseline. Baseline was the average of % predicted FEV1 values at 30 min and 0 min pre-dose. At each visit, the area under the curve is calculated over the post-dose timepoints. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC. (NCT02741271)
Timeframe: Baseline, and average of Day 1, Weeks 1, 4, 8, and 12
| Intervention | Percent predicted FEV1 (Mean) |
|---|
| Baseline | Change from Baseline |
|---|
| MF MDI 100 mcg BID | 78.48 | 3.96 |
,| MF/F MDI 100/10 mcg BID | 79.21 | 8.99 |
Change From Baseline in AM Pre-Dose % Predicted FEV1 With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment
The change from baseline in AM pre-dose % predicted FEV1 with MF/F MDI 100/10 mcg BID vs MF MDI 100 mcg BID averaged over 12 weeks treatment was assessed. This secondary analysis of the change from baseline used the cLDA method without multiple imputation. A model-based MAR approach was used for missing data. (NCT02741271)
Timeframe: Baseline and Weeks 4, 8, and 12 (Averaged)
| Intervention | Percent predicted FEV1 (Mean) |
|---|
| Baseline | Change from Baseline (Weeks 4, 8, and 12) |
|---|
| MF MDI 100 mcg BID | 78.22 | 0.44 |
,| MF/F MDI 100/10 mcg BID | 79.21 | 1.51 |
Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment
The key secondary objective was to determine the onset of action for the efficacy of MF/F MDI 100/10 mcg BID, compared with MF MDI 100 mcg BID. The post-dose AM % predicted FEV1 was averaged sequentially, and the change from baseline on Day 1 was assessed. This key secondary endpoint was controlled for multiplicity in a step-down fashion, based on trial success defined as a statistically significant improvement in the primary endpoint for MF/F vs MF. Missing data were imputed using control-based multiple imputations with the cLDA model. (NCT02741271)
Timeframe: Baseline and Day 1, measured at 4 hr, 2 hr and 60, 30, 15, and 5 min, post-dose time points
| Intervention | Percent predicted FEV1 (Mean) |
|---|
| Baseline | Change from Baseline (4 hr post-dose on Day 1) | Change from Baseline (2 hr post-dose on Day 1) | Change from Baseline (60 min post-dose on Day 1) | Change from Baseline (30 min post-dose on Day 1) | Change from Baseline (15 min post-dose on Day 1) | Change from Baseline (5 min post-dose on Day 1) |
|---|
| MF MDI 100 mcg BID | 78.48 | 5.68 | 5.87 | 4.92 | 3.05 | 1.38 | 0.95 |
,| MF/F MDI 100/10 mcg BID | 79.21 | 11.61 | 12.71 | 11.05 | 9.56 | 8.00 | 5.20 |
Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE. (NCT02741271)
Timeframe: Up to 24 weeks
| Intervention | Participants (Count of Participants) |
|---|
| MF/F MDI 100/10 mcg BID | 0 |
| MF MDI 100 mcg BID | 3 |
| Total | 3 |
Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment
This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 4 hours post-dose on Day 1 and Week 12 compared to Baseline. Baseline was the average of 30 and 0 minutes pre-dose % predicted FEV1 values. The AUC was calculated over the scheduled timepoints of 0 min, 5 min, 15 min, 30 min, 60 min, 2 hr and 4 hr post-dose. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC. (NCT02741271)
Timeframe: Baseline, Day 1 and Week 12
| Intervention | Percent predicted FEV1 (Mean) |
|---|
| Baseline | Change from Baseline on Day 1 | Change from Baseline at Week 12 |
|---|
| MF MDI 100 mcg BID | 78.48 | 2.70 | 4.87 |
,| MF/F MDI 100/10 mcg BID | 79.21 | 7.13 | 7.56 |
Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate
Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment. (NCT02741271)
Timeframe: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
| Intervention | hr (Median) |
|---|
| Pooled MF/F 100/10 mcg and MF 100 mcg | 1.47 |
Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period
To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the number of participants whose use of SABA rescue medication increased in Weeks 1-12 (individually) of the double-blind treatment period was assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for relief of asthma symptoms. (NCT02741271)
Timeframe: Weeks 1-12 (Averaged)
| Intervention | Participants (Number) |
|---|
| MF/F MDI 100/10 mcg BID | 24 |
| MF MDI 100 mcg BID | 34 |
Maximum Plasma Concentration (Cmax) of Mometsone Furoate
Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment. (NCT02741271)
Timeframe: Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12
| Intervention | pg/mL (Geometric Mean) |
|---|
| Pooled MF/F 100/10 mcg and MF 100 mcg | 16 |
Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE)
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE. (NCT02741271)
Timeframe: Up to 26 weeks
| Intervention | Participants (Count of Participants) |
|---|
| MF/F MDI 100/10 mcg BID | 37 |
| MF MDI 100 mcg BID | 52 |
| Total | 89 |
Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period
To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the number of participants using SABA rescue medication in Weeks 1-12 (individually) of the double-blind treatment period was assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for as-needed relief of asthma symptoms. (NCT02741271)
Timeframe: Baseline and Weeks 1-12 (Averaged)
| Intervention | Participants (Number) |
|---|
| Baseline | Weeks 1-12 |
|---|
| MF MDI 100 mcg BID | 17 | 45 |
,| MF/F MDI 100/10 mcg BID | 23 | 41 |
SNOT-22 (Sino-Nasal Outcome Test-22) Score
"Measurement of secondary outcome- the SNOT-22 test contains 22 items regarding patient-reported outcomes of sino-nasal symptom severity on a 0-5 scale for each item. 0 is no problem and 5 is problem as bad as it can be, so higher values represent a worse outcome than lower values. The subscale is 0 - 5 of each of the 22 items and the total score is the sum of the subscales of all 22 items. The minimum total score is 0/110. The maximum total score is 110/110.~This secondary outcome measured change in patient-reported outcomes of nasal symptoms as measured by Sino Nasal Outcome Test-22 (SNOT-22) over 12 weeks in the AZD1981 group vs. the placebo group." (NCT02874144)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) |
|---|
| Visit 1 (baseline) | Visit 5 (12 weeks) |
|---|
| AZD + INCS | 33.73 | 26.07 |
,| PLACEBO + INCS | 40.41 | 36.13 |
Sinus CT Scan Scores by Lund-Mackay Scores
Measurement of secondary outcome: sinus CT scan scores by Lund-Mckay scores. We measured sinus radiographic severity with Lund-Mackay scores of 0 to 24. 0 was the least severe and 24 was the most severe. This secondary outcomes included change in radiographic severity of sinus disease, as measured by sinus CT scan scores at baseline and 12 weeks in the AZD1981 group vs. the placebo group. (NCT02874144)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) |
|---|
| Visit 1 (Baseline) | Visit 5 (12 weeks) |
|---|
| AZD + INCS | 17.44 | 18.25 |
,| PLACEBO + INCS | 15.53 | 16.33 |
BSIT (Brief Smell Identification Test)
"Measurement of secondary outcome- BSIT (brief smell identification test) is a 12-item test measuring sense of smell. This is a multiple choice test with one correct answer out of four possible answer choices. This test features distinct types of smells. Minimum score: 0/12, which indicates that none of the correct answers were chosen on the 12-item test. Maximum score: 12/12, which indicates that all of the correct answers were chosen on the 12-item test. The higher the score, the better the outcome. Only one out of the four possible answer choices for each multiple choice question is correct. There are no subscales.~This secondary outcome measures sense of smell by Brief Smell Identification Test (B-SIT) at baseline (visit 1) and 12 weeks (visit 5) in the AZD1981 group vs. the placebo group." (NCT02874144)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) |
|---|
| Visit 1 (Baseline) | Visit 5 (12 weeks) |
|---|
| AZD + INCS | 5.75 | 6.92 |
,| PLACEBO + INCS | 5.20 | 5.80 |
TOTAL POLYP SCORE (TPS)
"Measure Description:~Measurement of Primary outcome- 0-4 scale in each nostril, total is 8. The total polyp score is the sum of the right and left nasal polyp score. Maximum is 8, minimum is 0. Higher score indicates worse disease. 0 =No polyps 1=Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate 2=Polyps reaching the lower border of the middle turbinate or polyp medial to the middle turbinate 3 = Large polyps reaching the lower border of the inferior turbinate 4 =Large polyps causing complete obstruction.~The primary outcome measured change in polyp size and secondary outcomes included change in radiographic severity of sinus disease, quality of life, and nasal symptoms as measured by Sino Nasal Outcome Test-22 (SNOT-22) and sense of smell by Brief Smell Identification Test (B-SIT) at 12 weeks in the AZD1981 group vs. the placebo. These were done at the baseline visit and the Week 12 visit." (NCT02874144)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) |
|---|
| AZD + INCS | 4.67 |
| PLACEBO + INCS | 5.24 |
Visual Analog Scale (VAS)
Measurement of secondary outcome- 0 to 10 scale bilaterally that measures how subjective sinus symptom severity, with 0 being the least troublesome to 10 being the most troublesome over 12 weeks in the AZD1981 group vs. the placebo group. (NCT02874144)
Timeframe: Baseline and Week 12
| Intervention | units on a scale (Mean) |
|---|
| Visit 1 | Visit 5 |
|---|
| AZD + INCS | 5.57 | 4.75 |
,| PLACEBO + INCS | 5.70 | 4.74 |
Patency Rate
Patency of the frontal recess/frontal sinus ostia (FSO) was evaluated on a 3-point grading scale from 0 to 2, with 0=Patent, 1=Restenosed/partially occluded, and 2=Occluded. The percentage of sinuses with patency grade 0 and 1 was used to calculate the patency rate. (NCT02880514)
Timeframe: Day 30
| Intervention | sinus sides (Count of Units) |
|---|
| PROPEL Mini Sinus Implant | 38 |
| Balloon Sinus Dilation Alone | 33 |
Inflammation Score
Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes) (NCT02880514)
Timeframe: Day 30
| Intervention | mm (Mean) |
|---|
| PROPEL Mini Sinus Implant | 43.2 |
| Balloon Sinus Dilation Alone | 45.8 |
The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period
Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS (Systemic Corticosteroids) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations (NCT02892344)
Timeframe: Week 12
| Intervention | Number of exacerbation (Number) |
|---|
| Moderate or severe asthma exacerbation | All (mild, moderate, severe) asthma exacerbation |
|---|
| MF 200 µg | 0.31 | 0.67 |
,| QMF149 150/80 μg | 0.08 | 0.20 |
Rescue Medication Use Over 12 Weeks
Rescue salbutamol/albuterol usage (mean daily, nighttime and daytime use) from e-Diary recordings over 12 weeks of treatment (NCT02892344)
Timeframe: week 12
| Intervention | Number of puffs of rescue medication (Least Squares Mean) |
|---|
| Night-time number of puffs of rescue medication | Daytime number of puffs of rescue medication |
|---|
| MF 200 µg | -0.16 | -0.24 |
,| QMF149 150/80 μg | -0.26 | -0.39 |
PEF Over 4 and 12 Weeks
Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration (NCT02892344)
Timeframe: week 12
| Intervention | L/min (Least Squares Mean) |
|---|
| Mean Morning PEF (n=382,382) | Mean Evening PEF (n=386,386) |
|---|
| MF 200 µg | 3.8 | 0.7 |
,| QMF149 150/80 μg | 31.0 | 26.8 |
Trough FEV1 at Day 2
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing (NCT02892344)
Timeframe: Day 2
| Intervention | Liters (Least Squares Mean) |
|---|
| QMF149 150/80 μg | 2.490 |
| MF 200 µg | 2.358 |
Trough FEV1
demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry. (NCT02892344)
Timeframe: week 12
| Intervention | Liters (Least Squares Mean) |
|---|
| QMF149 150/80 μg | 2.562 |
| MF 200 µg | 2.379 |
Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12
The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score. (NCT02892344)
Timeframe: week 12
| Intervention | Score (Least Squares Mean) |
|---|
| QMF149 150/80 μg | 5.779 |
| MF 200 µg | 5.630 |
ACQ-7 at Week 4
ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control (NCT02892344)
Timeframe: week 4
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| QMF149 150/80 μg | 1.454 |
| MF 200 µg | 1.658 |
ACQ-7
ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. the ACQ-7 was used to assess improvements in asthma symptom control. The ACQ-7, a seven-item disease-specific instrument developed and validated to assess asthma control in patients in clinical trials as well as in individuals in clinical practice, was provided to the site. All seven items were then scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating no control. The questions were equally weighted and the total score was the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the patient while the last question (question 7) was completed by the study investigator using spirometry data generated by the spirometry equipment. (NCT02892344)
Timeframe: week 12
| Intervention | Units on a scale (Least Squares Mean) |
|---|
| QMF149 150/80 μg | 1.323 |
| MF 200 µg | 1.540 |
Pre-dose FEV1 at Week 4
Pre-dose FEV1 is defined as the mean of -45 min and -15 min FEV1 values pre-evening dose (NCT02892344)
Timeframe: week 4
| Intervention | Liters (Least Squares Mean) |
|---|
| QMF149 150/80 μg | 2.545 |
| MF 200 µg | 2.369 |
Number of Patients With Asthma Exacerbation Over 12 Weeks
The exacerbation categories are: mild, moderate, severe and the combination of moderate or severe. Time to first asthma exacerbation by exacerbation category. Annual rate of asthma exacerbations by exacerbation category. (NCT02892344)
Timeframe: Week 12
| Intervention | Number of patients (Number) |
|---|
| Mild asthma exacerbation | Moderate asthma exacerbation | Severe asthma exacerbation | Moderate or severe asthma exacerbation |
|---|
| MF 200 µg | 29 | 23 | 11 | 32 |
,| QMF149 150/80 μg | 11 | 7 | 3 | 10 |
Percentage of Rescue Medication Free Days Over 12 Weeks
Percentage of rescue medication free days over 12 weeks of treatment period (NCT02892344)
Timeframe: week 12
| Intervention | Percentage (Least Squares Mean) |
|---|
| QMF149 150/80 μg | 22.2 |
| MF 200 µg | 14.1 |
Percentage of Patients With ACQ-7 MID at Week 12
MID is Minimum Important Difference. ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. Percent of patients achieving the minimal important difference (MID) in ACQ-7 (i.e. at least 0.5 decrease from baseline) will be measured. (NCT02892344)
Timeframe: week 12
| Intervention | Percentage (Number) |
|---|
| QMF149 150/80 μg | 74.7 |
| MF 200 µg | 64.9 |
Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period
The annual rate of asthma exacerbations were analyzed using a generalized linear model. (NCT02892344)
Timeframe: Week 12
| Intervention | Count of participants (Number) |
|---|
| QMF149 150/80 μg | 10 |
| MF 200 µg | 32 |
FVC Over 12 Weeks
FVC is the total amount of air exhaled during the FEV test. Forced Vital Capacity (FVC) and Forced Expiratory Flow between 25% and 75% of FVC (FEF25-75) will be measured (NCT02892344)
Timeframe: week 12
| Intervention | Liters (Least Squares Mean) |
|---|
| Pre dose trough FVC (n=383,379) | Pre-dose trough FEF25-75% (n=383,379) |
|---|
| MF 200 µg | 3.353 | 1.742 |
,| QMF149 150/80 μg | 3.453 | 2.030 |
Daily E-diary Over 12 Weeks
Percentage of asthma symptoms free days, the percentage of nights without nighttime awakenings, and the percentage of mornings without symptoms on awakening as recorded by daily electronic Diary (e-Diary) over 12 weeks of treatment (NCT02892344)
Timeframe: week 12
| Intervention | Percentage (Least Squares Mean) |
|---|
| % of nights with no night-time awakenings | % of mornings with no symptoms on awakening | % of asthma symptom-free days |
|---|
| MF 200 µg | 8.7 | 11.2 | 14.4 |
,| QMF149 150/80 μg | 13.4 | 14.7 | 17.1 |
Change From Baseline at Week 24 in 22-item Sino-nasal Outcome Test (SNOT-22) Scores
The SNOT-22 is a validated questionnaire was used to assess the impact of chronic rhinosinusitis phenotype with nasal polyps (CRSwNP) on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -10.40 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -27.77 |
Change From Baseline at Week 24 in Asthma Control Questionnaire-6 (ACQ-6) for Participants With Asthma
ACQ-6 had 6 questions which assessed the most common asthma symptoms (woken by asthma, symptoms on waking, activity limitation, shortness of breath, wheezing, puffs/inhalations use). Participants were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale ranged from 0 = no impairment to 6 = maximum impairment. The ACQ-6 score was the mean of the scores of all 6 questions and therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), with higher scores indicated lower asthma control. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment, asthma status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 0.08 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -0.78 |
Change From Baseline at Week 24 in European Quality of Life 5 Dimension Scale (EQ-5D) Visual Analog Scale Score
The EQ-5D was a standardized HRQoL questionnaire consisting of EQ-5D descriptive system and EQ VAS. The EQ-5D descriptive system comprised of 5 dimensions: mobility, selfcare, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. EQ VAS recorded the participant's self-rated health on a vertical VAS that allowed them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 3.91 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | 10.83 |
Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score
NC symptom severity was assessed by the participants on a daily basis from visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Least squares (LS) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.38 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -1.25 |
Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Asthma
NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.39 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -1.36 |
Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Prior Nasal Polyp Surgery
NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.27 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -1.30 |
Change From Baseline at Week 24 in Nasal Peak Inspiratory Flow (NPIF)
NPIF evaluation represented a physiologic measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute. Higher NPIF values were indicative of better nasal air flow. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | liters per minute (Least Squares Mean) |
|---|
| Placebo | 18.65 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | 55.29 |
Change From Baseline at Week 24 in Nasal Polyp Score
NPS: sum of right, left nostril scores, evaluated by nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller sized polyps. Total NPS: sum of right and left nostril scores, ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 0.10 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -1.71 |
Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Asthma
NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 0.13 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -1.88 |
Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Prior Nasal Polyp Surgery
NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 0.22 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -1.73 |
Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay (LMK) Score
The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. NOTE: For Japan regulatory submission only, this endpoint is not included as a secondary outcome measure and is instead one of the co-primary outcome measures. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.09 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -5.21 |
Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Asthma
The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.33 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -5.86 |
Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Prior Nasal Polyp Surgery
The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.10 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -5.42 |
Change From Baseline at Week 24 in Rhinorrhea Daily Symptom Score
Rhinorrhea was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), where higher scores indicated more severe symptoms. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.40 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -0.99 |
Change From Baseline at Week 24 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily
The severity of decreased/loss of sense of smell was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), higher score indicated more severe symptoms. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.23 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -1.21 |
Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score
The UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.81 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | 9.71 |
Change From Baseline at Week 24 in Total Symptom Score (TSS)
The TSS was the sum of participant-assessed nasal symptom scores for NC/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranged from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated more severe symptoms. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -1.00 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -3.45 |
Change From Baseline at Week 24 in Visual Analogue Scale (VAS) for Rhinosinusitis
"The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters VAS the answer to the question, How troublesome are your symptoms of your rhinosinusitis? The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments." (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | centimeters (Least Squares Mean) |
|---|
| Placebo | -1.39 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | -4.32 |
Change From Baseline at Week 52 in 22-item Sino-nasal Outcome Test Scores
The SNOT-22 is a validated questionnaire that was used to assess the impact of CRSwNP on HRQoL. It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -9.06 |
| Dupilumab 300 mg q2w Then q4w | -30.42 |
| Dupilumab 300 mg q2w | -29.79 |
Change From Baseline at Week 52 in Asthma Control Questionnaire-6 for Participants With Asthma
ACQ-6 had 6 questions which assessed the most common asthma symptoms (woken by asthma, symptoms on waking, activity limitation, shortness of breath, wheezing, puffs/inhalations use). Participants were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale ranged from 0 = no impairment to 6 = maximum impairment. The ACQ-6 score was the mean of the scores of all 6 questions and therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), with higher scores indicated lower asthma control. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment, asthma status, prior surgery history, and regions as covariates. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 0.12 |
| Dupilumab 300 mg q2w Then q4w | -0.76 |
| Dupilumab 300 mg q2w | -0.83 |
Change From Baseline at Week 52 in European Quality of Life 5 Dimension Scale Visual Analog Scale Score
The EQ-5D was a standardized HRQoL questionnaire consisting of EQ-5D descriptive system and EQ VAS. The EQ-5D descriptive system comprised of 5 dimensions: mobility, selfcare, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. EQ VAS recorded the participant's self-rated health on a vertical VAS that allowed them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 1.38 |
| Dupilumab 300 mg q2w Then q4w | 11.98 |
| Dupilumab 300 mg q2w | 13.14 |
Change From Baseline at Week 52 in Forced Expiratory Volume in 1 Second for Participants With Asthma
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, prior surgery history, and regions as covariates. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | liters (Least Squares Mean) |
|---|
| Placebo | -0.18 |
| Dupilumab 300 mg q2w Then q4w | 0.10 |
| Dupilumab 300 mg q2w | 0.06 |
Change From Baseline at Week 52 in Nasal Congestion/Obstruction Symptom Severity Score
NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.37 |
| Dupilumab 300 mg q2w Then q4w | -1.48 |
| Dupilumab 300 mg q2w | -1.36 |
Change From Baseline at Week 52 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Asthma
NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.34 |
| Dupilumab 300 mg q2w Then q4w | -1.51 |
| Dupilumab 300 mg q2w | -1.44 |
Change From Baseline at Week 52 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Prior Nasal Polyp Surgery
NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.25 |
| Dupilumab 300 mg q2w Then q4w | -1.54 |
| Dupilumab 300 mg q2w | -1.35 |
Change From Baseline at Week 52 in Nasal Polyp Score
NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 0.16 |
| Dupilumab 300 mg q2w Then q4w | -2.05 |
| Dupilumab 300 mg q2w | -2.24 |
Change From Baseline at Week 52 in Nasal Polyp Score: Subgroup of Participants With Asthma
NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 0.29 |
| Dupilumab 300 mg q2w Then q4w | -2.25 |
| Dupilumab 300 mg q2w | -2.34 |
Change From Baseline at Week 52 in Opacification of Sinuses Measured by Lund-Mackay Score
The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 0.11 |
| Dupilumab 300 mg q2w Then q4w | -5.60 |
| Dupilumab 300 mg q2w | -6.83 |
Change From Baseline at Week 52 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Prior Nasal Polyp Surgery
The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.06 |
| Dupilumab 300 mg q2w Then q4w | -6.01 |
| Dupilumab 300 mg q2w | -7.45 |
Change From Baseline at Week 52 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Asthma
The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.20 |
| Dupilumab 300 mg q2w Then q4w | -6.23 |
| Dupilumab 300 mg q2w | -7.22 |
Change From Baseline at Week 52 in Nasal Polyp Score: Subgroup of Participants With Prior Nasal Polyp Surgery
NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 0.21 |
| Dupilumab 300 mg q2w Then q4w | -2.22 |
| Dupilumab 300 mg q2w | -2.56 |
Rescue Treatment Use: Estimate of Percentage of Participants With Greater Than or Equal to (>=) 1 Event by Week 52 Obtained Using Kaplan-Meier Method
"Rescue treatment was defined as usage of systemic corticosteroids (SCS) or NP surgery (actual or planned) during the treatment period. Rescue treatment included:~SCS: betamethasone, deflazacort, dexamethasone, dexamethasone sodium phosphate, hydrocortisone, meprednisone, methylprednisolone, methylprednisolone sodium succinate, prednisolone, prednisolone sodium succinate, prednisone, stelamin, triamcinolone, and triamcinolone acetonide.~Sino-nasal surgery for nasal polyps when there was worsening of signs and/or symptoms during the study.~Estimate of percentage of participants with event by Week 52 was obtained using Kaplan-Meier method." (NCT02898454)
Timeframe: Baseline up to 52 weeks
| Intervention | percentage of participants with event (Number) |
|---|
| SCS treatment | NP surgery |
|---|
| Dupilumab 300 mg (Pooled Arm) | 13.1 | 5.5 |
,| Placebo | 42.5 | 28.3 |
Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies Response (ADA)
ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as a positive response in the ADA assay post first dose, when baseline results are negative or missing. 2) Treatment boosted was defined as: an ADA positive response in the assay post first dose that is greater-than or equal to 4-fold over baseline titer levels, when baseline results are positive. (NCT02898454)
Timeframe: Baseline to Week 52
| Intervention | Participants (Count of Participants) |
|---|
| With treatment-emergent ADA | With treatment-boosted ADA |
|---|
| Dupilumab 300 mg q2w | 8 | 0 |
,| Dupilumab 300 mg q2w Then q4w | 18 | 0 |
,| Placebo | 6 | 1 |
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation
An Adverse Event (AE) was defined as any untoward medical occurrence that did not necessarily have to have a causal relationship with the study treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during TEAE period which was defined as the period from the time of first dose of drug until 84 days following the last administration of drug. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. (NCT02898454)
Timeframe: Baseline up to 84 days after last dose of study drug (up to 64 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| Any TEAE | Any treatment emergent SAE | Any TEAE leading to death | TEAE leading to treatment discontinuation |
|---|
| Dupilumab 300 mg q2w | 125 | 8 | 0 | 6 |
,| Dupilumab 300 mg q2w Then q4w | 134 | 12 | 1 | 2 |
,| Placebo | 138 | 16 | 0 | 17 |
Functional Dupilumab Concentration in Serum
(NCT02898454)
Timeframe: Baseline, Week 2, Week 4, Week 16, Week 24, Week 40, End of treatment (Week 52), End of study (Week 64)
| Intervention | nanogram/milliliter (Mean) |
|---|
| Baseline | Week 2 | Week 4 | Week 16 | Week 24 | Week 40 | Week 52 | Week 64 |
|---|
| Dupilumab 300 mg q2w | 0.00 | 22285.67 | 37326.31 | 74382.04 | 79890.06 | 80526.37 | 75872.58 | 851.30 |
,| Dupilumab 300 mg q2w Then q4w | 0.00 | 21545.79 | 33760.62 | 70503.07 | 75929.41 | 21052.06 | 17276.13 | 53.60 |
Total Systemic Corticosteroids Rescue Intake Duration: Average Duration Per Participant
Rescue treatment was defined as usage of SCS or NP surgery (actual or planned) during the treatment period. SCS Rescue intake duration was defined as the duration (in days) from start of SCS rescue medication till the end of SCS rescue treatment. (NCT02898454)
Timeframe: Baseline to Week 52
| Intervention | days (Mean) |
|---|
| Placebo | 19.58 |
| Dupilumab 300 mg q2w Then q4w | 10.71 |
| Dupilumab 300 mg q2w | 23.23 |
Mean Total Systemic Corticosteroids Rescue Dose Prescribed During Treatment Period
SCS included: betamethasone, deflazacort, dexamethasone, dexamethasone sodium phosphate, hydrocortisone, meprednisone, methylprednisolone, methylprednisolone sodium succinate, prednisolone, prednisolone sodium succinate, prednisone, stelamin, triamcinolone, and triamcinolone acetonide. For every participant, the total dose was calculated as (prescribed total daily dose*duration of SCS use). Then, mean of the total dose of 64 participants (placebo group), 17 participants (dupilumab 300 mg q2w then q4w) and 22 participants (dupilumab 300 mg q2w) was derived. (NCT02898454)
Timeframe: Baseline to Week 52
| Intervention | milligrams (Mean) |
|---|
| Placebo | 547.56 |
| Dupilumab 300 mg q2w Then q4w | 282.38 |
| Dupilumab 300 mg q2w | 389.68 |
Changed From Baseline at Week 24 in Forced Expiratory Volume in 1 Second (FEV1) for Participants With Asthma
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments. (NCT02898454)
Timeframe: Baseline, Week 24
| Intervention | liters (Least Squares Mean) |
|---|
| Placebo | -0.05 |
| Dupilumab 300 mg (24 Weeks Pooled Arm) | 0.17 |
Change From Baseline at Week 52 in Visual Analogue Scale for Rhinosinusitis
"The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters VAS the answer to the question, How troublesome are your symptoms of your rhinosinusitis? The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates." (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | centimeters (Least Squares Mean) |
|---|
| Placebo | -0.93 |
| Dupilumab 300 mg q2w Then q4w | -4.39 |
| Dupilumab 300 mg q2w | -4.74 |
Change From Baseline at Week 52 in Total Symptom Score
The TSS was the sum of participant-assessed nasal symptom scores for NC/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranged from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated more severe symptoms. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.93 |
| Dupilumab 300 mg q2w Then q4w | -4.17 |
| Dupilumab 300 mg q2w | -3.79 |
Change From Baseline at Week 52 in the University of Pennsylvania Smell Identification Test Score
The UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.78 |
| Dupilumab 300 mg q2w Then q4w | 9.99 |
| Dupilumab 300 mg q2w | 9.53 |
Change From Baseline at Week 52 in Severity of Decreased/Loss of Smell
The severity of decreased/loss of sense of smell was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), higher score indicated more severe symptoms. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.18 |
| Dupilumab 300 mg q2w Then q4w | -1.49 |
| Dupilumab 300 mg q2w | -1.29 |
Change From Baseline at Week 52 in Rhinorrhea Daily Symptom Score
Rhinorrhea was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), where higher scores indicated more severe symptoms. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. (NCT02898454)
Timeframe: Baseline, Week 52
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.35 |
| Dupilumab 300 mg q2w Then q4w | -1.19 |
| Dupilumab 300 mg q2w | -1.15 |
Change From Baseline at Week 24 in 22-item Sino-nasal Outcome Test (SNOT-22) Scores
The SNOT-22 is a validated questionnaire that was used to assess the impact of chronic rhinosinusitis phenotype with nasal polyps (CRSwNP) on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -9.31 |
| Dupilumab 300 mg | -30.43 |
Change From Baseline at Week 24 in Visual Analogue Scale (VAS) for Rhinosinusitis
"The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters (cm) VAS the answer to the question, How troublesome are your symptoms of your rhinosinusitis? The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates." (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | centimeters (Least Squares Mean) |
|---|
| Placebo | -1.34 |
| Dupilumab 300 mg | -4.54 |
Change From Baseline at Week 24 in Nasal Polyp Score
NPS: sum of right, left nostril scores, evaluated by nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller-sized polyps. Total NPS: sum of right and left nostril scores; ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 0.17 |
| Dupilumab 300 mg | -1.89 |
Change From Baseline at Week 24 in Nasal Peak Inspiratory Flow (NPIF)
NPIF evaluation represented a physiologic measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute. Higher NPIF values are indicative of better nasal air flow. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | liters per minute (Least Squares Mean) |
|---|
| Placebo | 14.09 |
| Dupilumab 300 mg | 54.50 |
Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score
NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Least squares (LS) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model described in Statistical Analysis Overview. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.45 |
| Dupilumab 300 mg | -1.34 |
Change From Baseline at Week 24 in Nasal Congestion Symptom Severity Score: Subgroup of Participants With Prior Nasal Polyp Surgery
NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.52 |
| Dupilumab 300 mg | -1.41 |
Change From Baseline at Week 24 in Nasal Congestion Symptom Severity Score: Subgroup of Participants With Asthma
NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.36 |
| Dupilumab 300 mg | -1.48 |
Change From Baseline at Week 24 in Forced Expiratory Volume in 1 Second (FEV1) for Participants With Asthma
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | liters (Least Squares Mean) |
|---|
| Placebo | -0.06 |
| Dupilumab 300 mg | 0.15 |
Change From Baseline at Week 24 in European Quality of Life 5 Dimension (EQ-5D) Visual Analog Scale Score
The EQ-5D was a standardized HRQoL questionnaire consisting of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprised of 5 dimensions: mobility, selfcare, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. EQ-VAS recorded the participant's self-rated health on a vertical VAS that allowed them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 1.74 |
| Dupilumab 300 mg | 12.00 |
Rescue Treatment Use: Estimate of Percentage of Participants With >=1 Event by Week 48 Obtained Using Kaplan-Meier Method
"Rescue treatment was defined as usage of SCS or NP surgery (actual or planned) during the study. Rescue treatment included:~SCS: Betamethasone, dexamethasone, dexamethasone sodium phosphate, Hydrocortisone sodium succinate, methylprednisolone, prednisolone, prednisolone metasulfobenzoate sodium, prednisone, and triamcinolone.~Sino-nasal surgery for nasal polyps when there was worsening of signs and/or symptoms during the study.~Estimate of percentage of participants with event by Week 48 was obtained using Kaplan-Meier method." (NCT02912468)
Timeframe: Baseline up to Week 48
| Intervention | percentage of participants with event (Number) |
|---|
| SCS treatment | NP surgery |
|---|
| Dupilumab 300 mg | 21.4 | 6.3 |
,| Placebo | 28.8 | 12.5 |
Rescue Treatment Use: Estimate of Percentage of Participants With >=1 Event by Week 24 Obtained Using Kaplan-Meier Method
"Rescue treatment was defined as usage of systemic corticosteroids (SCS) or NP surgery (actual or planned) during the treatment period. Rescue treatment included:~SCS: Betamethasone, dexamethasone, dexamethasone sodium phosphate, Hydrocortisone sodium succinate, methylprednisolone, prednisolone, prednisolone metasulfobenzoate sodium, prednisone, and triamcinolone.~Sino-nasal surgery for nasal polyps when there was worsening of signs and/or symptoms during the study.~Estimate of percentage of participants with event by Week 24 was obtained using Kaplan-Meier method." (NCT02912468)
Timeframe: Baseline up to Week 24
| Intervention | percentage of participants with event (Number) |
|---|
| SCS treatment | NP surgery |
|---|
| Dupilumab 300 mg | 6.5 | 2.1 |
,| Placebo | 18.9 | 7.5 |
Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies (ADA) Response
ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as a positive response in the ADA assay post first dose, when baseline results are negative or missing. 2) Treatment boosted was defined as: An ADA positive response in the assay post first dose that is greater-than or equal to 4-fold over baseline titer levels, when baseline results are positive. (NCT02912468)
Timeframe: Baseline to End of study (Week 48)
| Intervention | Participants (Count of Participants) |
|---|
| With treatment-emergent ADA | With treatment-boosted ADA |
|---|
| Dupilumab 300 mg | 22 | 0 |
,| Placebo | 7 | 0 |
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation
An Adverse Event (AE) was defined as any untoward medical occurrence that did not necessarily have to have a causal relationship with the study treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during TEAE period which was defined as the period from the time of first dose of study drug until 98 days following the last administration of study drug. Serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. (NCT02912468)
Timeframe: Baseline up to 98 days following the last administration of study drug (up to 36 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| Any TEAE | Any treatment emergent SAE | TEAE leading to treatment discontinuation |
|---|
| Dupilumab 300 mg | 93 | 6 | 5 |
,| Placebo | 93 | 19 | 3 |
Functional Dupilumab Concentration in Serum
(NCT02912468)
Timeframe: Baseline, Week 4, 8, 16, 24, 36, End of study (Week 48)
| Intervention | nanogram/milliliter (Mean) |
|---|
| Baseline | Week 4 | Week 8 | Week 16 | Week 24 | Week 36 | Week 48 |
|---|
| Dupilumab 300 mg | 0.00 | 31267.18 | 48306.73 | 63958.12 | 69224.11 | 356.53 | 39.00 |
Change From Baseline at Week 24 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily
The severity of decreased/loss of sense of smell was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), higher score indicated more severe symptoms. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.29 |
| Dupilumab 300 mg | -1.41 |
Change From Baseline at Week 24 in Rhinorrhea Daily Symptom Score
Rhinorrhea was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), where higher scores indicated more severe symptoms. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.42 |
| Dupilumab 300 mg | -1.04 |
Change From Baseline at Week 24 in Asthma Control Questionnaire-6 (ACQ-6) Scores for Participants With Asthma
ACQ-6 had 6 questions which assessed the most common asthma symptoms (woken by asthma, symptoms on waking, activity limitation, shortness of breath, wheezing, puffs/inhalations use). Participants were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale ranged from 0 = no impairment to 6 = maximum impairment. The ACQ-6 score was the mean of the scores of all 6 questions and therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), with higher scores indicated lower asthma control. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, prior surgery, and regions as covariates. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.24 |
| Dupilumab 300 mg | -1.00 |
Change From Baseline at Week 24 in Total Symptom Score (TSS)
The TSS was the sum of participant-assessed nasal symptom scores for nasal congestion/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranged from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated more severe symptoms. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -1.17 |
| Dupilumab 300 mg | -3.77 |
Total Systemic Corticosteroids Rescue Intake Duration: Average Duration Per Participant
Rescue treatment was defined as usage of SCS or NP surgery (actual or planned) during the treatment period. SCS rescue intake duration was defined as the duration (in days) from start of SCS rescue medication till the end of SCS rescue treatment. (NCT02912468)
Timeframe: Baseline to Week 24
| Intervention | days (Mean) |
|---|
| Placebo | 11.04 |
| Dupilumab 300 mg | 23.33 |
Mean Total Systemic Corticosteroids Rescue Dose Prescribed During Treatment Period
SCS included: Betamethasone, dexamethasone, dexamethasone sodium phosphate, hydrocortisone sodium succinate, methylprednisolone, prednisolone, prednisolone metasulfobenzoate sodium, prednisone, and triamcinolone. For every participant, total dose was calculated as (prescribed total daily dose*duration of SCS use). Then, mean of the total dose of 25 participants (placebo group) and 9 participants (Dupilumab group) was derived. (NCT02912468)
Timeframe: Baseline to Week 24
| Intervention | milligrams (Mean) |
|---|
| Placebo | 366.07 |
| Dupilumab 300 mg | 686.65 |
Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score
The UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 0.70 |
| Dupilumab 300 mg | 11.26 |
Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund-Mackay (LMK) Score
The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. NOTE: For Japan regulatory submission only, this endpoint is not included as a secondary outcome measure and is instead one of the co-primary outcome measures. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.74 |
| Dupilumab 300 mg | -8.18 |
Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Prior Nasal Polyp Surgery
The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.39 |
| Dupilumab 300 mg | -7.60 |
Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Asthma
The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | -0.15 |
| Dupilumab 300 mg | -7.97 |
Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Prior Nasal Polyp Surgery
NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 0.14 |
| Dupilumab 300 mg | -1.86 |
Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Asthma
NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model. (NCT02912468)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Placebo | 0.27 |
| Dupilumab 300 mg | -1.89 |
Percentage of Participants With Nasal Surgery Over Time
The percentage of participants with nasal surgery over time (by Weeks 8, 16, 24, 32, 40, 48 and 52) was derived from Kaplan-Meier time-to-event analyses for the event 'first nasal surgery'. Nasal surgery was defined as any procedure involving instruments resulting in incision and removal of tissue (polypectomy) in the nasal cavity. Time to first nasal surgery was defined as (Date of first nasal surgery - Date of first dose of study treatment) + 1. Percentage of participants with nasal surgery over time (by Weeks 8, 16, 24, 32, 40, 48 and 52) and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method. Analysis included surgeries occurring up to Week 52, reported on-treatment and those reported after early discontinuation from IP by participants who remained in the study. (NCT03085797)
Timeframe: Weeks 8, 16, 24, 32, 40, 48 and 52
| Intervention | Percentage of participants (Number) |
|---|
| Week 8 | Week 16 | Week 24 | Week 32 | Week 40 | Week 48 | Week 52 |
|---|
| Mepolizumab 100 mg SC | 0.5 | 1.0 | 4.0 | 6.0 | 7.6 | 9.2 | 9.2 |
,| Placebo | 1.0 | 3.5 | 9.1 | 14.2 | 18.9 | 22.0 | 23.6 |
Percentage of Participants Requiring at Least One Course of Systemic Steroids for Nasal Polyps up to Week 52
The number of courses of systemic steroids received by participants were recorded. For the purpose of this study, a course of systemic corticosteroid separated by less than 7 days was considered as a continuation of the same course. Percentage of participants requiring at least one course of systemic steroids for nasal polyps up to Week 52 is presented. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. (NCT03085797)
Timeframe: Up to Week 52
| Intervention | Percentage of participants (Number) |
|---|
| Placebo | 37 |
| Mepolizumab 100 mg SC | 25 |
Change From Baseline in the Composite VAS Score (Combining VAS Scores for Nasal Obstruction, Nasal Discharge, Mucus in the Throat and Loss of Smell) During the 4 Weeks Prior to Week 52
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from electronically captured scores by dividing by 10. The composite VAS score was calculated as average of individual scores of nasal obstruction, nasal discharge, mucus in the throat and loss of smell and ranged between 0 and 10, with higher scores indicating greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value. (NCT03085797)
Timeframe: Baseline and Weeks 49 to 52
| Intervention | Scores on a scale (Median) |
|---|
| Placebo | -0.89 |
| Mepolizumab 100 mg SC | -3.96 |
Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52
"The SNOT-22 is a 22-item self-reported questionnaire developed to measure symptoms and impacts related to chronic rhinosinusitis. The 22 questions are self-completed by participants based on their recall of their symptoms over the previous 2 weeks using a 6-point rating scale (0 = Not present/no problem; 1 = Very mild problem; 2 = Mild or slight problem; 3 = Moderate problem; 4 = Severe problem; 5 = Problem as bad as it can be). Scores for each question are summed to derive the total score. The SNOT-22 total score ranges from 0 to 110, with higher scores representing worse quality of life. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value." (NCT03085797)
Timeframe: Baseline (Day 1) and Week 52
| Intervention | Scores on a scale (Median) |
|---|
| Placebo | -14.0 |
| Mepolizumab 100 mg SC | -30.0 |
Change From Baseline in Overall VAS Score During the 4 Weeks Prior to Week 52
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final overall VAS score ranged between 0 and 10, with higher scores indicating greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value. (NCT03085797)
Timeframe: Baseline and Weeks 49 to 52
| Intervention | Scores on a scale (Median) |
|---|
| Placebo | -0.90 |
| Mepolizumab 100 mg SC | -4.48 |
Change From Baseline in Nasal Obstruction Visual Analog Scale (VAS) Score During the 4 Weeks Prior to Week 52
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale (VAS) using an electronic diary (eDiary). Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final nasal obstruction VAS score ranged between 0 and 10, with higher scores indicating greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value. (NCT03085797)
Timeframe: Baseline and Weeks 49 to 52
| Intervention | Scores on a scale (Median) |
|---|
| Placebo | -0.82 |
| Mepolizumab 100 mg SC | -4.41 |
Change From Baseline in Total Endoscopic Nasal Polyps Score at Week 52
Independent reviewers, blinded to treatment, reviewed image recordings of nasal endoscopies to determine total endoscopic NP score based on NP size. The right and left nostrils were scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction/congestion of the inferior meatus). The total score is the sum of the right and left nostril scores and ranges from 0 to 8, higher scores indicate greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. Baseline was defined as Day 1 value. Change from Baseline = Post-baseline value minus Baseline value. (NCT03085797)
Timeframe: Baseline (Day 1) and Week 52
| Intervention | Scores on a scale (Median) |
|---|
| Placebo | 0.0 |
| Mepolizumab 100 mg SC | -1.0 |
Change From Baseline in Individual VAS Symptom Score: Loss of Smell During the 4 Weeks Prior to Week 52
Participants rated individual (nasal obstruction, nasal discharge, mucus in the throat, loss of smell, facial pain) and overall symptoms on a visual analog scale using an eDiary. Captured scores ranged between 0 (none) and 100 (as bad as you can imagine), final scores derived from the electronically captured scores by dividing by 10. The final loss of smell VAS score ranged between 0 and 10, with higher scores indicating greater disease severity. Data up to Week 52, including from participants who remained in the study after early discontinuation from IP, were included in analysis. The average of daily scores in 4-weekly intervals were calculated and data is presented for Weeks 49-52. Baseline was defined as the average score from the 7 days of eDiary data collected prior to Day 1. Change from Baseline = Post-baseline value minus Baseline value. (NCT03085797)
Timeframe: Baseline and Weeks 49 to 52
| Intervention | Scores on a scale (Median) |
|---|
| Placebo | 0.00 |
| Mepolizumab 100 mg SC | -0.53 |
Total Number of Courses of SCS for NP
The total number of courses of systemic corticosteroids (SCS) use for nasal polyposis (NP) was summarized using descriptive statistics. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | number of courses (Mean) |
|---|
| Benra 30 mg | 1.7 |
| Placebo | 1.6 |
Total Duration of SCS_NP (Days)
The total duration of systemic corticosteroids (SCS) for nasal polyposis (NP) in days was summarized using descriptive statistics. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | days (Mean) |
|---|
| Benra 30 mg | 17.6 |
| Placebo | 20.1 |
Time to the First NP Surgery up to Week 56
The cumulative percentage and the corresponding 95% CI are based on the Kaplan-Meier estimates. Patients can have more than 1 rescue category during the study, and the first rescue per patient is considered. The time to first nasal polyposis (NP) surgery up to week 56 was calculated based on the earliest occurrence of NP surgery and was calculated as follows: Time to first NP surgery=Start date of first NP surgery - date of randomization + 1. For patients who did not experience any surgery, the time to event was censored at earlier of (date of their week 56 visit, date of discontinuation). (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | months (Number) |
|---|
| Benra 30 mg | 16.6 |
| Placebo | 19.5 |
Time to First SCS_NP up to Week 56
The cumulative percentage and the corresponding 95% CI are based on the Kaplan-Meier estimates. Patients can have more than 1 rescue category during the study, and the first rescue per patient is considered. The time to first systemic corticosteroids for use for nasal polyposis (SCS_NP) up to week 56 was calculated based on the earliest occurrence of SCS_ NP and was calculated as follows: Time to first SCS_NP = Earlier of (Start date of first SCS use for NP) - date of randomization + 1. For patients who did not experience any SCS use for NP, the time to event was censored at earlier of (date of their week 56 visit, date of discontinuation). The time to first SCS use for NP surgery was analyzed using a Cox proportional hazard model with treatment arm, region (US vs non-US) and baseline comorbid asthma status (yes vs no) as covariates. A hazard ratio less than 1 indicates a lower rate of incidence for subjects on benra. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | months (Number) |
|---|
| Benra 30 mg | 25.7 |
| Placebo | 33.5 |
Time to First NP Surgery and/or SCS Use for NP to Week 56
The cumulative percentage and the corresponding 95% CI are based on the Kaplan-Meier estimates. Patients can have more than 1 rescue category during the study, and the first rescue per patient is considered. The time to first nasal polyposis (NP) surgery and/or systemic corticosteroids (SCS) use for NP up to week 56 was calculated based on the earliest occurrence of NP surgery and/or SCS use for NP and was calculated as follows: Time to first NP surgery and/or SCS use for NP = Earlier of (Start date of first NP surgery, Start date of first SCS use for NP) - date of randomization + 1. For patients who did not experience any surgery or SCS use for NP, the time to event was censored at earlier of (date of their week 56 visit, date of discontinuation). (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | months (Number) |
|---|
| Benra 30 mg | 35.5 |
| Placebo | 46.5 |
Percentage of Subjects With SCS_NP
The percentage of patients who had systemic corticosteroids (SCS) use for nasal polyposis (NP) surgery up to week 56 was summarized and analyzed using the Cochran-Mantel-Haenszel test stratified by region (US vs non-US) and baseline comorbid asthma status (yes vs no). (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Participants (Count of Participants) |
|---|
| Benra 30 mg | 52 |
| Placebo | 66 |
Change From Baseline in Difficulty With Daily Activities Due to Nasal Symptoms at Week 40
Change from baseline in difficulty with daily activities due to nasal symptoms score at week 40 was defined as the endpoint at week 40 minus baseline value. The score was captured by an item in NPSD. The severity of difficulty with daily activities due to nasal symptoms over the past 24 hours was rated using options: 0-none; 1-mild; 2-moderate; 3-severe. The score and change from baseline were summarized every two weeks (bi-weekly). Baseline was average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for nasal polyposis (SCS_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS_NP and multiple imputation (MI) assuming MAR were used to build the complete imputation datasets for the analysis. (NCT03401229)
Timeframe: Baseline to week 40
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -0.35 |
| Placebo | -0.11 |
Change From Baseline in Total NPS at Week 40
Change from baseline in total nasal polyps score (NPS) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The total NPS was the sum of the right and left nostril scores and maximum total NPS is 8, as evaluated by nasal endoscopy and the left and right score were based on central read with scale from 0 to 4 where higher score reflects heavier bilateral nasal polyp burden. Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. (NCT03401229)
Timeframe: Baseline to week 40
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -0.36 |
| Placebo | 0.17 |
Change From Baseline in SF-36v2 Physical Component Summary at Week 56
Change from baseline in SF-36v2 physical component summary (PCS) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. PCS score is computed from 8 subscale scores to give a broader metric of physical health-related quality of life. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -1.557 |
| Placebo | -3.185 |
Change From Baseline in SF-36v2 Physical Functioning at Week 56
Change from baseline in SF-36v2 physical functioning score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. Physical functioning is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | 0.080 |
| Placebo | -0.911 |
Change From Baseline in SNOT-22 at Week 56
Change from baseline in SinoNasal outcome test (SNOT-22) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The SNOT-22 is a condition specific health-related quality of life assessment which captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal conditions. The total score is range from 0 to 110 (higher scores indicate poorer outcomes). Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -15.1 |
| Placebo | -7.9 |
Change From Baseline in SF-36v2 Role Limitations Due to Emotional Problems at Week 56
Change from baseline in SF-36v2 role limitations due to emotional problems score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. Role limitations due to emotional problems is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -0.492 |
| Placebo | -1.825 |
Change From Baseline in SF-36v2 Role Limitations Due to Physical Health at Week 56
Change from baseline in SF-36v2 role limitations due to physical health score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. Role limitations due to physical health is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | 1.576 |
| Placebo | 0.025 |
Change From Baseline in SF-36v2 Social Functioning at Week 56
Change from baseline in SF-36v2 social functioning score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 are used to compute an 8-domain profile of functional health and well-being scores. Social functioning is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | 0.262 |
| Placebo | -1.247 |
Change From Baseline in SF-36v2 Vitality at Week 56
Change from baseline in SF-36v2 vitality score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. Vitality is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | 1.913 |
| Placebo | -0.594 |
Change From Baseline in SNOT-22 at Week 40
Change from baseline in SinoNasal outcome test (SNOT-22) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The SNOT-22 is a condition specific health-related quality of life assessment which captures patient-reported physical problems, functional limitations, and emotional consequences of sinonasal conditions. The total score is the sum of item scores and has a range from 0 to 110 (higher scores indicate poorer outcomes). Baseline was the last valid value on or prior to the date of randomization. Data collected after NP surgery and/or SCS_NP were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. (NCT03401229)
Timeframe: Baseline to week 40
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -15.2 |
| Placebo | -10.7 |
Change From Baseline in DSS at Week 40
Change from baseline in difficulty with sense of smell (DSS) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The DSS is captured by an item in the NPSD. Severity of worst difficulty with sense of smell over the past 24 hours was rated with response options: 0-none; 1-mild; 2-moderate; 3-severe. The DSS and the changes from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids use for NP (SCS_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. (NCT03401229)
Timeframe: Baseline to week 40
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -0.34 |
| Placebo | -0.16 |
Change From Baseline in Difficulty With Sleeping Due to Nasal Symptoms at Week 40
Change from baseline in difficulty with sleeping due to nasal symptoms score at week 40 was defined as the endpoint at week 40 minus baseline value. The score was captured by an item in NPSD. The severity of difficulty with sleeping due to nasal symptoms over past 24 hours was rated using options: 0-none; 1-mild; 2-moderate; 3-severe. The score and change from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for nasal polyposis (SCS_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis (NCT03401229)
Timeframe: Baseline to week 40
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -0.39 |
| Placebo | -0.19 |
Change From Baseline in Sinus Severity Score at EOT/IPD
Change from baseline in sinus severity score at end of treatment (EOT)/investigational product discontinuation (IPD) was defined as the endpoint value at EOT/IPD minus the baseline value. Quantitative assessment of sinus CT image data was used to derive an objective measure of sinus disease burden called sinus severity score. The sinus severity score is defined as (sinus mucosal volume)/(sinus mucosal volume + sinus air volume)×100. A composite strategy was used for NP surgery. If a patient had NP surgery before EOT/IPD CT scan, the data was censored after the time of the first NP surgery and the worst possible value (WP) was imputed in its place. In calculation of summary statistics (mean and standard deviation), the WP for NP surgery rescued subjects was applied. In ANCOVA, following WP (WP for NP surgery rescued subjects), model included treatment, baseline score, region (US/Non-US) and baseline comorbid asthma status. (NCT03401229)
Timeframe: Baseline to EOT/IPD, up to 56 weeks
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -3.48 |
| Placebo | 0.79 |
Annual SCS_NP Use Rate Comparison by Period, Negative Binomial Model
Annual systemic corticosteroids for nasal polyposis (SCS_NP) use rate =365.25×total number of courses of SCS_NP /total duration of follow-up within the treatment group (days). The estimated annual event rates, absolute differences, rate ratio and the corresponding confidence interval were based on a negative binomial model including covariates treatment group, region (US/non-US) and prior use of SCS_NP with total number of courses of SCS_NP as the outcome and the log of each subject's corresponding follow-up time up to week 56 as an offset variable in the model to adjust for subject's having different exposure times during which the events occur. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | number of courses for each patient (Mean) |
|---|
| Benra 30 mg | 0.40 |
| Placebo | 0.50 |
Percentage of Subjects With NP Surgery or SCS_NP
The percentage of patients who had nasal polyposis (NP) surgery or systemic corticosteroids use for nasal polyposis (SCS_NP) surgery up to week 56 was summarized and analyzed using the Cochran-Mantel-Haenszel test stratified by region (US vs non-US) and baseline comorbid asthma status (yes vs no). (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Participants (Count of Participants) |
|---|
| Benra 30 mg | 72 |
| Placebo | 91 |
Percentage of Subjects With NP Surgery
The percentage of patients who had nasal polyposis (NP) surgery or systemic corticosteroids use for nasal polyposis (SCS_NP) surgery up to week 56 was summarized and analyzed using the Cochran-Mantel-Haenszel test stratified by region (US vs non-US) and baseline comorbid asthma status (yes vs no). (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Participants (Count of Participants) |
|---|
| Benra 30 mg | 33 |
| Placebo | 37 |
Change From Baseline in UPSIT Score in Males at Week 40
Change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score at week 40 was defined as the endpoint value at week 40 minus the baseline value. The UPSIT is quantitative test of olfactory function. Scores were based on number of correctly identified odors (score range 0 to 40). Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for nasal polyposis (SCS_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. (NCT03401229)
Timeframe: Baseline to week 40
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -0.20 |
| Placebo | 0.09 |
Change From Baseline in UPSIT Score in Females at Week 40
Change from baseline in University of Pennsylvania Smell Identification Test (UPSIT) score at week 40 was defined as the endpoint value at week 40 minus the baseline value. The UPSIT is quantitative test of olfactory function. Scores are based on number of correctly identified odors (score range 0 to 40). Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for nasal polyposis (SCS_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. (NCT03401229)
Timeframe: Baseline to week 40
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | 1.66 |
| Placebo | -1.32 |
Change From Baseline in DSS at Week 56
Change from baseline in difficulty with sense of smell (DSS) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The DSS is captured by an item in the NPSD with response options: 0-none; 1-mild; 2-moderate; 3-severe to rate the severity of their worst difficulty with sense of smell over past 24 hours. The DSS and the changes from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -0.39 |
| Placebo | -0.21 |
Change From Baseline in LMS at EOT/IPD
Change from baseline in Computed tomography (CT) Lund Mackay Score (LMS) at end of treatment (EOT)/investigational product discontinuation (IPD) was defined as the endpoint value at EOT/IPD minus the baseline value. The LMS evaluates the patency using a 0-2 scale (0-normal; 1-partial opacification; and 2-total opacification) of each sinus (maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side). The osteomeatal complex is graded as 0- not occluded or 2-occluded. The total CT score is the sum of the scores from all the sinus and ranges from 0 to 24. The minimum is 0 and higher score indicates worse outcome. The analysis used the data collected after systemic corticosteroids for nasal polyposis (SCS_NP). A composite strategy was used for NP surgery. If a patient had NP surgery before EOT/IPD CT scan, the data was censored after the time of the first NP surgery and the worst possible value (WP) was imputed in its place. (NCT03401229)
Timeframe: Baseline to EOT/IPD, up to 56 weeks
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -0.93 |
| Placebo | -0.20 |
Change From Baseline in NBS at Week 40
Change from baseline in nasal blockage score (NBS) at week 40 was defined as the endpoint value at week 40 minus the baseline value. The NBS was captured by an item in NPSD. Patients were asked to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0-none; 1-mild; 2-moderate; 3-severe. The NBS and the changes from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. (NCT03401229)
Timeframe: Baseline to week 40
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -0.68 |
| Placebo | -0.41 |
Change From Baseline in NBS at Week 56
Change from baseline in nasal blockage score (NBS) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The NBS is captured by an item in the NPSD. Patients were asked to rate the severity of their worst nasal blockage over the past 24 hours using the following response options: 0-none; 1-mild; 2-moderate; 3-severe. The NBS and the changes from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -0.68 |
| Placebo | -0.38 |
Change From Baseline in NPS at Week 56
Change from baseline in total nasal polyps score (NPS) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The total NPS is the sum of the right and left nostril scores, as evaluated by nasal endoscopy and the left and right score are based on central read with scale from 0 to 4 where higher score reflects heavier bilateral nasal polyp burden. Baseline was the last valid value on or prior to the date of randomization. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. In ANCOVA, a hybrid method of WP after NP surgery, WOCF after SCS_NP and multiple imputation (MI) assuming missing at random were used to build the complete imputation datasets for the analysis. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -0.22 |
| Placebo | 0.18 |
Change From Baseline in SF-36v2 Bodily Pain at Week 56
Change from baseline in SF-36v2 bodily pain score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. Bodily pain is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | 0.982 |
| Placebo | -1.066 |
Change From Baseline in SF-36v2 General Health Perceptions at Week 56
Change from baseline in SF-36v2 general health perceptions score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. General health perceptions is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing are excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | 0.445 |
| Placebo | -1.064 |
Change From Baseline in SF-36v2 Mental Component Summary at Week 56
Change from baseline in SF-36v2 mental component summary (MCS) at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. MCS score is computed from 8 subscale scores to give a broader metric of mental health-related quality of life. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -2.263 |
| Placebo | -4.182 |
Change From Baseline in SF-36v2 Mental Health at Week 56
Change from baseline in SF-36v2 mental health score at week 56 was defined as the endpoint value at week 56 minus the baseline value. The Short Form 36-item Health survey (SF-36v2) is a 36-item, self-report survey of functional health and wellbeing, with 4-week recall period. Responses to SF-36v2 were used to compute an 8-domain profile of functional health and well-being scores. Mental health is one of the 8-domain profile. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for NP (SCS_NP) were set to missing. Non-rescued patients whose post-baseline observations were all missing were excluded from this analysis. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -1.506 |
| Placebo | -3.308 |
Change From Baseline in TSS at Week 40
Change from baseline in total symptom score (TSS) at week 40 was defined as the endpoint at week 40 minus baseline value. The TSS is defined as sum of first 8 NPSD components. Severity of each nasal symptoms over the past 24 hours is rated using response options: 0-none; 1-mild; 2-moderate; 3-severe. The TSS and the change from baseline were summarized every two weeks (bi-weekly). Baseline was the average of daily TSS responses from Day -13 to Day 1. Data collected after nasal polyposis (NP) surgery and/or systemic corticosteroids for nasal polyposis (SCS_NP) were set to missing. In calculation of summary statistics (mean and standard deviation), the worst-possible (WP) after NP surgery and worst-observation carried forward (WOCF) after SCS_NP were applied. In ANCOVA, a hybrid method of the WP after NP surgery, WOCF after SCS_NP and multiple imputation (MI) assuming MAR were used to build the complete imputation datasets for the analysis. (NCT03401229)
Timeframe: Baseline to week 40
| Intervention | Score on a scale (Mean) |
|---|
| Benra 30 mg | -3.20 |
| Placebo | -1.38 |
Total SCS_NP Dose (a) Used (mg)
The total systemic corticosteroids (SCS) for nasal polyposis (NP) dose used (mg) was summarized using descriptive statistics. (NCT03401229)
Timeframe: Baseline to week 56
| Intervention | milligrams (Mean) |
|---|
| Benra 30 mg | 1083.2 |
| Placebo | 435.2 |
Change From Baseline in Sino-Nasal Outcome Test-22 (SNOT-22) Score at Week 16
SNOT-22 is a 22-item outcome measure on a 5-category scale that assesses symptoms and social/emotional consequences of rhinosinusitis. Each item is scored from 0 (No problem at all) to 5 (Problem as bad as it can be), and the total score ranges from 0 to 110. Higher SNOT-22 scores are indicative of greater impact of rhinosinusitis on quality of life. A negative change from Baseline indicates improvement. (NCT03614923)
Timeframe: Baseline and Week 16
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Etokimab 300 mg + 150 mg Q4W | -22.97 |
| Etokimab 300 mg + 150 mg Q8W | -18.34 |
| Placebo | -16.32 |
Change From Baseline in Eosinophil Count
(NCT03614923)
Timeframe: Baseline, Week 16, and Week 24
| Intervention | 10^9 cells/L (Mean) |
|---|
| Baseline | Change from Baseline at Week 16 | Change from Baseline at Week 24 |
|---|
| Etokimab 300 mg + 150 mg Q4W | 0.437 | -0.162 | -0.038 |
,| Etokimab 300 mg + 150 mg Q8W | 0.350 | -0.117 | -0.029 |
,| Placebo | 0.434 | -0.020 | 0.019 |
Change From Baseline in Nasal Polyp Score (NPS) to Week 16
"Nasal polyps were evaluated by nasal endoscopy using centralized imaging data assessments scored by an independent reviewer.~Each nostril was scored on a scale from 0 to 4, where a score of 0 means no polyps, and a score of 4 means the presence of polyps causing complete obstruction of the inferior nasal cavity.~The bilateral NPS score is the sum of the right and left nostril scores, and hence the total NPS value is between 0 and 8 (worst). A negative change from Baseline indicates improvement." (NCT03614923)
Timeframe: Baseline and Week 16
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Etokimab 300 mg + 150 mg Q4W | -0.87 |
| Etokimab 300 mg + 150 mg Q8W | -0.89 |
| Placebo | -0.49 |
Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System
"A board-certified otolaryngologist will perform a nasal endoscopic examination pre- and post-intervention and findings recorded using the Lund-Kennedy grading system.~The The Lund Kennedy System grades the pathologic state of the nasal cavity based on the presence of polyps, nasal discharge, and mucosal edema.~Polyps graded from 0 to 2 (0=absent, 1=limited to middle meatus, 2=extending to nasal cavity) Discharge graded from 0 to 2 (0=absent, 1=thin/clear, 2=thick) Edema graded from 0 to 2 (0=absent, 1=mild/moderate, 2=polypoid degeneration). Scores are added for each side of the nose with a minimum score of 0 and maximum score of 12 with higher scores indicating more severe sinonasal inflammation." (NCT03705793)
Timeframe: Change from Baseline to Week 8
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Mometasone Furoate Nasal Irrigation | 2.2 |
| Mometasone Nasal Spray | 2.1 |
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
"The change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment between the two arms was measured. The Sino-Nasal Outcome Test asks subjects to rate how bad their rhinosinusitis is by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT includes 22 questions (symptoms and social/emotional consequences of rhinosinusitis), each of which are rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores representing worse outcome.~All relevant time points used in the calculation in the Time Frame (e.g., 'baseline and 8 weeks)" (NCT03705793)
Timeframe: Change from Baseline to Week 8
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Mometasone Furoate Nasal Irrigation | 23.18 |
| Mometasone Nasal Spray | 17.7 |
Number of Participants Who Score <3 on the Clinical Global Impression Scale
CGI asks subjects to rate their overall response to treatment using a 7-point Likert scale with anchors of 1=very much improved, 4=no change, and 7=very much worse. (NCT03705793)
Timeframe: Week 8
| Intervention | Participants (Count of Participants) |
|---|
| Mometasone Furoate Nasal Irrigation | 22 |
| Mometasone Nasal Spray | 20 |
Change From Baseline in the TNSS At Day 15 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 15
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 15 |
|---|
| Beclomethasone Dipropionate (BDP) | 7.9 | -3.8 |
,| Mometasone Furoate (MF) | 8.3 | -3.3 |
,| Placebo | 8.4 | -2.6 |
Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching, as rated in their diary in the morning (AM) and evening (PM). The 4 individual symptom scores rated as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For the 15 day interval, participant individual daily scores were totaled and averaged over interval (AM and PM computed separately then averaged) and used to calculate the overall average change from Baseline. Participant average changes were then used to calculate the mean change for each arm for the interval. Average change from Baseline for Days 1-15 = average post-treatment score (Days 1-15) - Baseline average score (average of the Baseline AM/PM diary scores from 3 consecutive days prior to Baseline visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline, and Days 1 through 15 (average of 15 days of treatment)
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Change from Baseline Days 1-15 |
|---|
| Beclomethasone Dipropionate (BDP) | 7.3 | -2.8 |
,| Mometasone Furoate (MF) | 7.6 | -2.3 |
,| Placebo | 7.6 | -1.5 |
Change From Baseline in the TNSS At Day 8 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 8
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 8 |
|---|
| Beclomethasone Dipropionate (BDP) | 7.9 | -3.8 |
,| Mometasone Furoate (MF) | 8.3 | -3.3 |
,| Placebo | 8.4 | -1.9 |
Change From Baseline in the TNSS At Day 4 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 4
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 4 |
|---|
| Beclomethasone Dipropionate (BDP) | 7.9 | -2.7 |
,| Mometasone Furoate (MF) | 8.3 | -2.4 |
,| Placebo | 8.4 | -1.8 |
Change From Baseline in the TNSS At Day 29 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 29
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 29 |
|---|
| Beclomethasone Dipropionate (BDP) | 7.9 | -4.6 |
,| Mometasone Furoate (MF) | 8.3 | -4.1 |
,| Placebo | 8.4 | -3.2 |
Change From Baseline in the TNSS At Day 22 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 22
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 22 |
|---|
| Beclomethasone Dipropionate (BDP) | 7.9 | -4.0 |
,| Mometasone Furoate (MF) | 8.3 | -3.9 |
,| Placebo | 8.4 | -3.2 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 8
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 8 |
|---|
| Beclomethasone Dipropionate (BDP) | 2.2 | -0.8 |
,| Mometasone Furoate (MF) | 2.3 | -0.7 |
,| Placebo | 2.2 | -0.3 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 22
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 22 |
|---|
| Beclomethasone Dipropionate (BDP) | 2.2 | -0.8 |
,| Mometasone Furoate (MF) | 2.3 | -0.9 |
,| Placebo | 2.2 | -0.6 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 4
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 4 |
|---|
| Beclomethasone Dipropionate (BDP) | 2.2 | -0.5 |
,| Mometasone Furoate (MF) | 2.3 | -0.6 |
,| Placebo | 2.2 | -0.3 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 4
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 4 |
|---|
| Beclomethasone Dipropionate (BDP) | 2.2 | -0.6 |
,| Mometasone Furoate (MF) | 2.2 | -0.6 |
,| Placebo | 2.3 | -0.4 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 8
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 8 |
|---|
| Beclomethasone Dipropionate (BDP) | 2.2 | -0.8 |
,| Mometasone Furoate (MF) | 2.2 | -0.7 |
,| Placebo | 2.3 | -0.4 |
Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who discontinued due to an AE was reported for each treatment group. (NCT03855189)
Timeframe: Up to 31 Days
| Intervention | Participants (Count of Participants) |
|---|
| Mometasone Furoate (MF) | 5 |
| Beclomethasone Dipropionate (BDP) | 2 |
| Placebo | 4 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 29
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 29 |
|---|
| Beclomethasone Dipropionate (BDP) | 2.2 | -0.9 |
,| Mometasone Furoate (MF) | 2.3 | -0.9 |
,| Placebo | 2.2 | -0.6 |
Number of Participants Who Experienced ≥1 Adverse Event
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants with at least one AE was reported for each treatment group. (NCT03855189)
Timeframe: Up to 31 Days
| Intervention | Participants (Count of Participants) |
|---|
| Mometasone Furoate (MF) | 60 |
| Beclomethasone Dipropionate (BDP) | 64 |
| Placebo | 78 |
Response To Therapy At Day 15 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. (NCT03855189)
Timeframe: Day 15
| Intervention | scores on a scale (Mean) |
|---|
| Mometasone Furoate (MF) | 3.0 |
| Beclomethasone Dipropionate (BDP) | 2.7 |
| Placebo | 3.3 |
Response To Therapy At Day 15 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. (NCT03855189)
Timeframe: Day 15
| Intervention | scores on a scale (Mean) |
|---|
| Mometasone Furoate (MF) | 3.0 |
| Beclomethasone Dipropionate (BDP) | 2.8 |
| Placebo | 3.3 |
Response To Therapy At Day 22 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. (NCT03855189)
Timeframe: Day 22
| Intervention | scores on a scale (Mean) |
|---|
| Mometasone Furoate (MF) | 2.9 |
| Beclomethasone Dipropionate (BDP) | 2.7 |
| Placebo | 3.1 |
Response To Therapy At Day 22 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. (NCT03855189)
Timeframe: Day 22
| Intervention | scores on a scale (Mean) |
|---|
| Mometasone Furoate (MF) | 2.8 |
| Beclomethasone Dipropionate (BDP) | 2.7 |
| Placebo | 3.1 |
Response To Therapy At Day 29 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. (NCT03855189)
Timeframe: Day 29
| Intervention | scores on a scale (Mean) |
|---|
| Mometasone Furoate (MF) | 2.9 |
| Beclomethasone Dipropionate (BDP) | 2.6 |
| Placebo | 3.3 |
Response To Therapy At Day 29 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. (NCT03855189)
Timeframe: Day 29
| Intervention | scores on a scale (Mean) |
|---|
| Mometasone Furoate (MF) | 2.9 |
| Beclomethasone Dipropionate (BDP) | 2.5 |
| Placebo | 3.2 |
Response To Therapy At Day 4 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. (NCT03855189)
Timeframe: Day 4
| Intervention | scores on a scale (Mean) |
|---|
| Mometasone Furoate (MF) | 3.3 |
| Beclomethasone Dipropionate (BDP) | 3.2 |
| Placebo | 3.6 |
Response To Therapy At Day 4 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. (NCT03855189)
Timeframe: Day 4
| Intervention | scores on a scale (Mean) |
|---|
| Mometasone Furoate (MF) | 3.3 |
| Beclomethasone Dipropionate (BDP) | 3.2 |
| Placebo | 3.5 |
Response To Therapy At Day 8 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. (NCT03855189)
Timeframe: Day 8
| Intervention | scores on a scale (Mean) |
|---|
| Mometasone Furoate (MF) | 3.0 |
| Beclomethasone Dipropionate (BDP) | 2.7 |
| Placebo | 3.5 |
Response To Therapy At Day 8 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. (NCT03855189)
Timeframe: Day 8
| Intervention | scores on a scale (Mean) |
|---|
| Mometasone Furoate (MF) | 3.0 |
| Beclomethasone Dipropionate (BDP) | 2.7 |
| Placebo | 3.5 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 15
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 15 |
|---|
| Beclomethasone Dipropionate (BDP) | 2.2 | -0.8 |
,| Mometasone Furoate (MF) | 2.2 | -0.7 |
,| Placebo | 2.3 | -0.5 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 15
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 15 |
|---|
| Beclomethasone Dipropionate (BDP) | 2.2 | -0.8 |
,| Mometasone Furoate (MF) | 2.3 | -0.7 |
,| Placebo | 2.2 | -0.5 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 22
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 22 |
|---|
| Beclomethasone Dipropionate (BDP) | 2.2 | -0.9 |
,| Mometasone Furoate (MF) | 2.2 | -0.9 |
,| Placebo | 2.3 | -0.7 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 29
| Intervention | scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 29 |
|---|
| Beclomethasone Dipropionate (BDP) | 2.2 | -0.9 |
,| Mometasone Furoate (MF) | 2.2 | -0.9 |
,| Placebo | 2.3 | -0.6 |
Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician)
"The mean change from baseline on study day 8 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity.~A negative change from baseline indicates a decrease in symptom severity." (NCT03855228)
Timeframe: Baseline and study day 8
| Intervention | Score on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 8 |
|---|
| Loratadine 10 mg | 15.9 | -5.2 |
,| MFNS 200 μg | 16.1 | -6.9 |
,| MFNS 200 μg + Loratadine 10 mg | 15.9 | -7.0 |
,| Placebo | 16.2 | -4.6 |
Response to Therapy on Day 8 (Assessed by Physician)
Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 8. A higher value indicates weaker response. (NCT03855228)
Timeframe: Study day 8
| Intervention | Score on a scale (Mean) |
|---|
| MFNS 200 μg + Loratadine 10 mg | 3.0 |
| MFNS 200 μg | 3.1 |
| Loratadine 10 mg | 3.4 |
| Placebo | 3.6 |
Response to Therapy on Day 15 (Assessed by Physician)
Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 15. A higher value indicates weaker response. (NCT03855228)
Timeframe: Study day 15
| Intervention | Score on a scale (Mean) |
|---|
| MFNS 200 μg + Loratadine 10 mg | 2.8 |
| MFNS 200 μg | 3.0 |
| Loratadine 10 mg | 3.4 |
| Placebo | 3.4 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician)
"The mean change from baseline on study day 15 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity.~A negative change from baseline indicates a decrease in symptom severity." (NCT03855228)
Timeframe: Baseline and study day 15
| Intervention | Score on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 15 |
|---|
| Loratadine 10 mg | 2.3 | -0.6 |
,| MFNS 200 μg | 2.3 | -0.9 |
,| MFNS 200 μg + Loratadine 10 mg | 2.3 | -0.9 |
,| Placebo | 2.3 | -0.6 |
Change From Baseline in Total Symptom Score (Assessed by Participant)
"Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB.~CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment. (NCT03855228)
Timeframe: Baseline and days 1 through 15 (average of 15 days of treatment)
| Intervention | Score on a scale (Mean) |
|---|
| Baseline | Change From Baseline Days 1-15 |
|---|
| Loratadine 10 mg | 14.4 | -3.8 |
,| MFNS 200 μg | 14.2 | -4.8 |
,| MFNS 200 μg + Loratadine 10 mg | 14.3 | -5.4 |
,| Placebo | 14.6 | -2.7 |
Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician)
"The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity.~A negative change from baseline indicates a decrease in symptom severity." (NCT03855228)
Timeframe: Baseline and study day 8
| Intervention | Score on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 8 |
|---|
| Loratadine 10 mg | 8.6 | -2.6 |
,| MFNS 200 μg | 8.6 | -3.6 |
,| MFNS 200 μg + Loratadine 10 mg | 8.7 | -3.7 |
,| Placebo | 8.8 | -2.2 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician)
"The mean change from baseline on study day 8 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity.~A negative change from baseline indicates a decrease in symptom severity." (NCT03855228)
Timeframe: Baseline and study day 8
| Intervention | Score on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 8 |
|---|
| Loratadine 10 mg | 2.3 | -0.5 |
,| MFNS 200 μg | 2.3 | -0.7 |
,| MFNS 200 μg + Loratadine 10 mg | 2.3 | -0.8 |
,| Placebo | 2.3 | -0.5 |
Change From Baseline in Total Nasal Symptom Score (Assessed by Participant)
"Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB.~CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment." (NCT03855228)
Timeframe: Baseline and days 1 through 15 (average of 15 days of treatment)
| Intervention | Score on a scale (Mean) |
|---|
| Baseline | Change From Baseline Days 1-15 |
|---|
| Loratadine 10 mg | 7.9 | -1.9 |
,| MFNS 200 μg | 7.8 | -2.7 |
,| MFNS 200 μg + Loratadine 10 mg | 7.9 | -3.0 |
,| Placebo | 8.0 | -1.4 |
Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician)
"The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity.~A negative change from baseline indicates a decrease in symptom severity." (NCT03855228)
Timeframe: Baseline and study day 15
| Intervention | Score on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 15 |
|---|
| Loratadine 10 mg | 8.6 | -3.1 |
,| MFNS 200 μg | 8.6 | -4.2 |
,| MFNS 200 μg + Loratadine 10 mg | 8.7 | -4.4 |
,| Placebo | 8.8 | -2.8 |
Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician)
"The mean change from baseline on study day 15 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity.~A negative change from baseline indicates a decrease in symptom severity." (NCT03855228)
Timeframe: Baseline and study day 15
| Intervention | Score on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 15 |
|---|
| Loratadine 10 mg | 15.9 | -6.2 |
,| MFNS 200 μg | 16.1 | -8.0 |
,| MFNS 200 μg + Loratadine 10 mg | 15.9 | -8.2 |
,| Placebo | 16.2 | -5.4 |
Baseline Overall Disease Condition Score for Calculation of Change From Baseline at Days 4, 8, and 15 as Assessed by Participant
The participant scored the overall condition of seasonal allergic rhinitis in a diary using the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. The baseline score was recorded preceding treatment. (NCT03861559)
Timeframe: Baseline (Day 1)
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 2.4 |
| Placebo Nasal Spray | 2.4 |
Baseline Total Nasal Symptom Score (TNSS) for Calculation of Change From Baseline at Days 4, 8, and 15 Visits as Assessed by Investigator
TNSS was assessed by the investigator who scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries using the scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. The baseline score was taken at the baseline visit preceding treatment. (NCT03861559)
Timeframe: Baseline (Day 1)
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 8.9 |
| Placebo Nasal Spray | 8.9 |
Baseline Overall Disease Condition Score for Calculation of Change From Baseline at Days 4, 8, and 15 Visits as Assessed by Investigator
The investigator scored the overall condition of seasonal allergic rhinitis for the participant during the study visits using the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. The baseline score was taken at the baseline visit preceding treatment. (NCT03861559)
Timeframe: Baseline (Day 1)
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 2.3 |
| Placebo Nasal Spray | 2.3 |
Change From Baseline (CFB) in Overall Disease Condition Score at Day 15 as Assessed by Participant
CFB on study Day 15 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant scored their overall condition on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 15 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. (NCT03861559)
Timeframe: Baseline (Day 1) and Day 15
| Intervention | Percent change (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -41 |
| Placebo Nasal Spray | -21 |
Baseline Total Nasal Symptom Score (TNSS) for Calculation of Change From Baseline Averaged Over 15 Days of Treatment as Assessed by Participant
TNSS was assessed by participants who scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries using the scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Scores were recorded twice daily, in morning (AM) and night (PM). The baseline score was an average of the three AM and three PM scores preceding treatment. (NCT03861559)
Timeframe: Baseline (3 days preceding treatment)
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 8.4 |
| Placebo Nasal Spray | 8.6 |
Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Investigator
CFB on study Day 4 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. (NCT03861559)
Timeframe: Baseline (Day 1) and Day 4
| Intervention | Percent change (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -22 |
| Placebo Nasal Spray | -16 |
Therapeutic Response to Treatment at Day 8 as Assessed by Investigator
Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 8. Treatment response was evaluated by the investigator using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms. (NCT03861559)
Timeframe: Day 8
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 2.9 |
| Placebo Nasal Spray | 3.5 |
Therapeutic Response to Treatment at Day 8 as Assessed by Participant
Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 8. Treatment response was evaluated by the participant using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms. (NCT03861559)
Timeframe: Day 8
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 2.9 |
| Placebo Nasal Spray | 3.6 |
Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Participant
CFB on study Day 4 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant scored their overall condition on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. (NCT03861559)
Timeframe: Baseline (Day 1) and Day 4
| Intervention | Percent change (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -24 |
| Placebo Nasal Spray | -18 |
Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Investigator
CFB on study Day 8 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. (NCT03861559)
Timeframe: Baseline (Day 1) and Day 8
| Intervention | Percent change (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -34 |
| Placebo Nasal Spray | -22 |
Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Participant
CFB on study Day 8 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant scored their overall condition on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. (NCT03861559)
Timeframe: Baseline (Day 1) and Day 8
| Intervention | Percent change (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -36 |
| Placebo Nasal Spray | -21 |
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 15 as Assessed by Investigator
CFB at Day 15 was calculated for TNSS assessed by the investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and endpoint scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant. (NCT03861559)
Timeframe: Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.
| Intervention | Percent change (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -43 |
| Placebo Nasal Spray | -27 |
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 4 as Assessed by Investigator
CFB on study Day 4 was calculated for TNSS assessed by investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on study Day 4, on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. (NCT03861559)
Timeframe: Baseline (Day 1) and Day 4
| Intervention | Percent change (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -34 |
| Placebo Nasal Spray | -16 |
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator
CFB on study Day 8 was calculated for TNSS assessed by investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. (NCT03861559)
Timeframe: Baseline (Day 1) and Day 8
| Intervention | Percent change (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -44 |
| Placebo Nasal Spray | -28 |
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) Averaged Over 15 Days of Treatment, as Assessed by Participant
"CFB, averaged over study days 1-15, was calculated for TNSS assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries using the scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. A decrease in symptom severity is reflected by a negative CFB.~Percent CFB was calculated as the difference between the baseline and 15-day average scores divided by baseline score multiplied by 100. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score was an average of the three AM and three PM scores preceding treatment." (NCT03861559)
Timeframe: Baseline (3 days preceding treatment) through Day 15 (averaged over 15 days)
| Intervention | Percent change (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -39 |
| Placebo Nasal Spray | -20 |
Change From Baseline in Overall Disease Condition Score at Day 15 as Assessed by Investigator
CFB on study Day 15 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 15 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant. (NCT03861559)
Timeframe: Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.
| Intervention | Percent change (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -41 |
| Placebo Nasal Spray | -18 |
Therapeutic Response to Treatment at Day 15 as Assessed by Investigator
Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 15. Treatment response was evaluated by the investigator using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant. (NCT03861559)
Timeframe: Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 2.7 |
| Placebo Nasal Spray | 3.7 |
Therapeutic Response to Treatment at Day 15 as Assessed by Participant
Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 15. Treatment response was evaluated by the participant using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms. (NCT03861559)
Timeframe: Day 15
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 2.8 |
| Placebo Nasal Spray | 3.6 |
Therapeutic Response to Treatment at Day 4 as Assessed by Investigator
Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 4. Treatment response was evaluated by the investigator using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms. (NCT03861559)
Timeframe: Day 4
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 3.2 |
| Placebo Nasal Spray | 3.8 |
Therapeutic Response to Treatment at Day 4 as Assessed by Participant
Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 4. Treatment response was evaluated by the participant using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms. (NCT03861559)
Timeframe: Day 4
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 3.2 |
| Placebo Nasal Spray | 3.8 |
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator
The mean change from baseline at study day 4 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. (NCT03879772)
Timeframe: Baseline (Day 1) and Day 4
| Intervention | Scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 4 |
|---|
| BDP 84 mcg BID | 8.0 | -2.4 |
,| MFNS 100 mcg QD | 8.1 | -2.0 |
,| MFNS 200 mcg QD | 7.9 | -2.0 |
,| MFNS 25 mcg QD | 7.8 | -2.2 |
,| Placebo | 8.0 | -1.3 |
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator
The mean change from baseline at study day 29 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. (NCT03879772)
Timeframe: Baseline (Day 1) and Day 29
| Intervention | Scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 29 |
|---|
| BDP 84 mcg BID | 8.0 | -3.7 |
,| MFNS 100 mcg QD | 8.1 | -3.7 |
,| MFNS 200 mcg QD | 7.9 | -3.8 |
,| MFNS 25 mcg QD | 7.8 | -3.1 |
,| Placebo | 8.0 | -2.5 |
Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant
Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity. (NCT03879772)
Timeframe: Baseline and Days 16 through 29 (average over 15 days)
| Intervention | Scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Days 16 to 29 |
|---|
| BDP 84 mcg BID | 6.6 | -2.6 |
,| MFNS 100 mcg QD | 6.9 | -2.8 |
,| MFNS 200 mcg QD | 6.9 | -2.7 |
,| MFNS 25 mcg QD | 6.3 | -2.1 |
,| Placebo | 6.8 | -1.7 |
Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant
Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity. (NCT03879772)
Timeframe: Baseline and Days 1 through 15 (average over 15 days)
| Intervention | Scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Days 1 to 15 |
|---|
| BDP 84 mcg BID | 6.6 | -1.9 |
,| MFNS 100 mcg QD | 6.9 | -1.9 |
,| MFNS 200 mcg QD | 6.9 | -1.8 |
,| MFNS 25 mcg QD | 6.3 | -1.5 |
,| Placebo | 6.8 | -1.2 |
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator
The mean change from baseline at study day 15 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. (NCT03879772)
Timeframe: Baseline (Day 1) and Day 15
| Intervention | Scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 15 |
|---|
| BDP 84 mcg BID | 8.0 | -3.5 |
,| MFNS 100 mcg QD | 8.1 | -3.0 |
,| MFNS 200 mcg QD | 7.9 | -3.1 |
,| MFNS 25 mcg QD | 7.8 | -2.9 |
,| Placebo | 8.0 | -2.4 |
Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator
The mean change from baseline at study day 8 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. (NCT03879772)
Timeframe: Baseline (Day 1) and Day 8
| Intervention | Scores on a scale (Mean) |
|---|
| Baseline | Change From Baseline Day 8 |
|---|
| BDP 84 mcg BID | 8.0 | -2.8 |
,| MFNS 100 mcg QD | 8.1 | -2.8 |
,| MFNS 200 mcg QD | 7.9 | -2.8 |
,| MFNS 25 mcg QD | 7.8 | -2.8 |
,| Placebo | 8.0 | -1.9 |
Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)
Change from baseline averaged over study Day 1 through study Day 15 was calculated for Total Nasal Symptom Score, based on participant diaries. Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in their diaries using the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The Total Nasal Symptom Score was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) Change from baseline was the 15-day average score minus the baseline score. Scores were recorded twice daily, in the morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. Baseline score was an average of the 3 AM scores and 3 PM scores preceding treatment. Negative changes indicated a decrease in symptom severity. (NCT03882047)
Timeframe: Baseline and Day 1 through Day 15 (averaged over 15 days)
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -2.8 |
| Fluticasone Propionate Nasal Spray | -3.4 |
| Placebo Nasal Spray | -0.9 |
Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation)
Change from baseline at Day 4 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity. (NCT03882047)
Timeframe: Baseline (Day 1) and Day 4
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -3.2 |
| Fluticasone Propionate Nasal Spray | -3.5 |
| Placebo Nasal Spray | -1.8 |
Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation)
Change from baseline at Day 15 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity. (NCT03882047)
Timeframe: Baseline (Day 1) and Day 15
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -4.4 |
| Fluticasone Propionate Nasal Spray | -5.5 |
| Placebo Nasal Spray | -2.7 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation)
Change from baseline at Day 4 was calculated for the Overall Condition of Seasonal Allergic Rhinitis, as assessed by the physician. The physician scored their overall condition on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity. (NCT03882047)
Timeframe: Baseline (Day 1) and Day 4
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -0.5 |
| Fluticasone Propionate Nasal Spray | -0.7 |
| Placebo Nasal Spray | -0.3 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation)
The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 4, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity. (NCT03882047)
Timeframe: Baseline (Day 1) and Day 4
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -0.6 |
| Fluticasone Propionate Nasal Spray | -0.8 |
| Placebo Nasal Spray | -0.3 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation)
Change from baseline at Day 15 was calculated for the overall condition of seasonal allergic rhinitis, as assessed by the physician. The physician scored their overall condition on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity. (NCT03882047)
Timeframe: Baseline (Day 1) and Day 15
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -0.9 |
| Fluticasone Propionate Nasal Spray | -1.2 |
| Placebo Nasal Spray | -0.5 |
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation)
The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 15, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity. (NCT03882047)
Timeframe: Baseline (Day 1) and Day 15
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | -1.1 |
| Fluticasone Propionate Nasal Spray | -1.3 |
| Placebo Nasal Spray | -0.5 |
Response to Therapy at Day 4 (Physician Evaluation)
Response to therapy was assessed by evaluating the participant's relief of nasal symptoms at Day 4. The physician evaluated the participant's response using the following 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms. (NCT03882047)
Timeframe: Day 4
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 3.2 |
| Fluticasone Propionate Nasal Spray | 3.1 |
| Placebo Nasal Spray | 3.8 |
Response to Therapy at Day 4 (Participant Evaluation)
Response to therapy was evaluated by participants and based upon their status scored at Day 4. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms. (NCT03882047)
Timeframe: Day 4
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 3.2 |
| Fluticasone Propionate Nasal Spray | 3.1 |
| Placebo Nasal Spray | 3.7 |
Response to Therapy at Day 15 (Physician Evaluation)
Response to therapy was assessed by evaluating the participant's relief of nasal symptoms at Day 15. The physician evaluated the participant's response using the following 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms. (NCT03882047)
Timeframe: Day 15
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 2.7 |
| Fluticasone Propionate Nasal Spray | 2.4 |
| Placebo Nasal Spray | 3.2 |
Response to Therapy at Day 15 (Participant Evaluation)
Response to therapy was evaluated by participants and based upon their status scored at Day 15. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms. (NCT03882047)
Timeframe: Day 15
| Intervention | Score on a scale (Mean) |
|---|
| Mometasone Furoate Nasal Spray | 2.6 |
| Fluticasone Propionate Nasal Spray | 2.4 |
| Placebo Nasal Spray | 3.4 |
Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC)
"FEV1 is air volume exhaled in 1 second during spirometry. Forced vital capacity is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. The change in FEV1/FVC was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months). This will be used as a measurement in asthma severity.~[A lower FEV1/FVC ratio indicates more severe asthma]" (NCT04179461)
Timeframe: Baseline to 12 months
| Intervention | Ratio (Median) |
|---|
| V1 | V2 | V3 |
|---|
| Personalized Treatment | 0.81 | 0.8 | 0.8 |
Asthma Control Test (ACT)
"ACT was measured by questionnaire, assessing frequency of reported asthma symptoms, rescue medication use, the effect of asthma on daily functioning, and overall asthma control. The change in ACT score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).~[The ACT score has a minimum value = 5, maximum value = 25, a score 19 indicates well-controlled asthma]" (NCT04179461)
Timeframe: Baseline to 12 months
| Intervention | score on a scale (Median) |
|---|
| V1 | V2 | V3 |
|---|
| Personalized Treatment | 23.0 | 21.7 | 22.5 |
Adherence of Asthma Controller Medication
Adherence was measured using the Propeller Health Inhaler monitor and web-based software management platform that tracks adherence of asthma medications. The change in adherence was calculated between V1 (baseline) to V3 (12 Months). (NCT04179461)
Timeframe: Baseline to 12 months
| Intervention | percentage of medication taken (Median) |
|---|
| V1 | V3 |
|---|
| Personalized Treatment | 42 | 36 |
Change in Composite Asthma Severity Index (CASI)
"CASI was measured by questionnaire and is a severity score of symptom burden, exacerbations, healthcare utilization, lung function and dose of inhaled corticosteroids. The change in CASI score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).~[The CASI score has a minimum value = 0, maximum value = 20, a higher score indicates greater asthma severity]" (NCT04179461)
Timeframe: Baseline to 12 months
| Intervention | score on a scale (Median) |
|---|
| V1 | V2 | V3 |
|---|
| Personalized Treatment | 5 | 5 | 5 |
The Percentage of Subjects Who Achieve Disease Control Without Rescue Therapy
Disease control is defined as ≤ 3 new blisters/eczematous lesions/urticarial plaques/day and healing of existing blisters/eczematous lesions/urticarial plaques without requiring rescue therapy. (NCT04499235)
Timeframe: Baseline to up to 3 weeks (until disease control)
| Intervention | Participants (Count of Participants) |
|---|
| Mometasone Furoate + AKST4290 | 2 |
| Mometasone Furoate + Placebo | 1 |
Total Cumulative Steroid Exposure
Total cumulative steroid exposure (cortisol equivalent/kg) by treatment group (NCT04499235)
Timeframe: Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control.
| Intervention | mg cortisol equivalent/kg (Mean) |
|---|
| Mometasone Furoate + AKST4290 | 260 |
Maximum Daily Steroid Dose
Evaluation of maximum daily steroid dose at baseline, by treatment week, and at disease control. Study Day 1 is defined as the initiation of study treatment. 1 mg/kg prednisolon(e) = 5 mg/kg cortisone. (NCT04499235)
Timeframe: Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control.
| Intervention | mg cortisol equivalent/kg (Number) |
|---|
| Maximum Daily Steroid Dose Occurred: Day 4 | Maximum Daily Steroid Dose Occurred: Day 8 | Maximum Daily Steroid Dose Occurred: Day 11 |
|---|
| Mometasone Furoate + AKST4290 | 175 | 150 | 150 |
Number of Participants With TEAEs, Assessed by Seriousness and Severity
Treatment-emergent AEs summarized by MedDRA coding terms; separate tabulations produced for incidence, seriousness and severity of AEs (NCT04499235)
Timeframe: Baseline to 5 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Subjects Reporting at Least One TEAE | Subjects Reporting at Least One Serious TEAE | TEAE by Severity: Mild | TEAE by Severity: Moderate | TEAE by Severity: Severe |
|---|
| Mometasone Furoate + AKST4290 | 2 | 0 | 2 | 0 | 0 |
,| Mometasone Furoate + Placebo | 1 | 1 | 0 | 0 | 1 |
The Bullous Pemphigoid Disease Area Index (BPDAI) Score
Change from baseline in BPDAI score at End of Treatment (EOT). Subscales for the BPDAI include the skin blister score (range 0-120), skin urticarial score (range 0-120), mucosal activity score (range 0-120), and damage score (range 0-12). Higher scores indicate greater disease activity or damage. (NCT04499235)
Timeframe: Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control.
| Intervention | score on a scale (Mean) |
|---|
| Total BPDAI Skin Blister Score: Baseline | Total BPDAI Skin Blister Score: EOT | Total BPDAI Skin Urticarial Score: Baseline | Total BPDAI Skin Urticarial Score: EOT | Total BPDAI Mucosal Activity Score: Baseline | Total BPDAI Mucosal Activity Score: EOT | Total BPDAI Damage Score: Baseline | Total BPDAI Damage Score: EOT |
|---|
| Mometasone Furoate + AKST4290 | 15 | 7.4 | 16.4 | 9.2 | 3.4 | 1.6 | 5.0 | 5.0 |
,| Mometasone Furoate + Placebo | 13.0 | 8.0 | 14.0 | 12.0 | 0 | 0 | 9.0 | 8.0 |
The Bullous Pemphigoid Disease Area Index Visual Analog Scale (BPDAI-VAS)
Change from baseline in pruritus as evaluated by the BPDAI-VAS at End of Treatment (EOT). EOT occurs at disease control (up to 3 weeks) or at Week 3 when the subject is discontinued from treatment due to not reaching disease control. Scores for the BPDAI-VAS can range from 0 to 30, with higher scores indicating a worse condition. (NCT04499235)
Timeframe: Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control.
| Intervention | score on a scale (Mean) |
|---|
| BPDAI-VAS Baseline | BPDAI-VAS EOT |
|---|
| Mometasone Furoate + AKST4290 | 19.4 | 9.2 |
,| Mometasone Furoate + Placebo | 15.0 | 4.0 |
Time to Rescue Therapy
Time to rescue therapy by treatment day/week. The time to rescue therapy is calculated as the start date of the first rescue therapy minus Date of Visit 2 (Baseline (Day 1)) plus 1. (NCT04499235)
Timeframe: Baseline to up to 3 weeks (EOT). EOT occurs at disease control (assessed every day from Week 1/Day 7 up to Week 3/Day 21 +/- 2 days) or at Week 3/Day 21 +/- 2 days when the subject is discontinued from treatment due to not reaching disease control.
| Intervention | Participants (Count of Participants) |
|---|
| Time (Days) to Rescue Therapy: 4 | Time (Days) to Rescue Therapy 8 | Time (Days) to Rescue Therapy 9 |
|---|
| Mometasone Furoate + AKST4290 | 1 | 1 | 1 |
,| Mometasone Furoate + Placebo | 0 | 0 | 0 |
Time to Disease Control
Time to disease control by treatment day/week. The time to disease control is calculated as the date of disease control minus Date of Visit 2 (Baseline (Day 1)) plus 1. (NCT04499235)
Timeframe: Baseline to up to 3 weeks (until disease control)
| Intervention | Participants (Count of Participants) |
|---|
| Time (Days) to Disease Control: 8 | Time (Days) to Disease Control: 11 | Time (Days) to Disease Control: 15 | Time (Days) to Disease Control: 16 | Time (Days) to Disease Control: 22 |
|---|
| Mometasone Furoate + AKST4290 | 1 | 2 | 0 | 1 | 1 |
,| Mometasone Furoate + Placebo | 0 | 0 | 1 | 0 | 0 |
Systemic Exposure to Indacaterol in Plasma
"Systemic exposure to indacaterol in plasma following sparse pharmacokinetic (PK) sampling on Day 6-9 after inhalation of QMF149.~A correction factor was applied to indacaterol plasma concentrations to consider the first-dose effect that is based on the fact that the participants in this study received a single dose from single unused (unprimed) C1 and TH devices. Unprimed devices are not coated with the formulation, and therefore may lead to lower fine particle mass (FPM) and delivered dose compared to later doses actuated from the device throughout its use time. The first-dose correction factor (FPMprimed (indacaterol) / FPMunprimed (indacaterol)) for indacaterol delivered via C1 was 2.0." (NCT04589663)
Timeframe: pre-dose, 0.25 and 1 hour post-dose on Day 6-9
| Intervention | pg/mL (Mean) |
|---|
| Pre-dose | 0.25 hours post-dose | 1 hours post-dose |
|---|
| MF Followed by QMF149 | 0 | 102.0 | 62.3 |