guaifenesin has been researched along with Disease Exacerbation in 58 studies
Guaifenesin: An expectorant that also has some muscle relaxing action. It is used in many cough preparations.
| Excerpt | Relevance | Reference |
|---|---|---|
| "George Respiratory Questionnaire-COPD, SGRQ-C)." | 2.94 | CXCR2 antagonist for patients with chronic obstructive pulmonary disease with chronic mucus hypersecretion: a phase 2b trial. ( Ambery, C; Donald, AC; Keeley, T; Lazaar, AL; Miller, BE; Russell, J; Tal-Singer, R; Watz, H, 2020) |
| "However, there is a risk of gastroesophageal reflux associated with this technique." | 2.52 | Standard (head-down tilt) versus modified (without head-down tilt) postural drainage in infants and young children with cystic fibrosis. ( Chaves, GS; Dias, FA; Ferreira, GM; Freitas, DA; Guerra, RO; Mendonça, KM; Ribeiro, CT, 2015) |
| "COPD is a worldwide public health problem that reduces the quality of life." | 2.48 | Pathobiologic mechanisms of chronic obstructive pulmonary disease. ( Sin, DD; Tam, A, 2012) |
| "Daily cough was recorded in 28." | 1.48 | Mucus hypersecretion in asthma is associated with rhinosinusitis, polyps and exacerbations. ( Crespo, A; García-Rivero, JL; López-Viña, A; Marina-Malanda, N; Martínez-Rivera, C; Mayoralas-Alises, S; Padilla, A; Pallarés-Sanmartín, A; Pascual-Erquicia, S; Picado, C; Pinedo-Sierra, C; Plaza, V, 2018) |
| "Depressed MCC in cystic fibrosis is associated with P." | 1.43 | Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung. ( Corcoran, TE; Czachowski, MR; Lacy, RT; Locke, LW; Markovetz, MR; Muthukrishnan, A; Myerburg, MM; Parker, RS; Pilewski, JM; Weber, L; Weiner, DJ, 2016) |
| "Mucoobstructive lung diseases have highlighted the importance of a proper description of the normal mucus clearance system." | 1.42 | On the Pathogenesis of Acute Exacerbations of Mucoobstructive Lung Diseases. ( Boucher, RC, 2015) |
| "Chlamydia infections are common causes of respiratory disease, particularly pneumonia in neonates, and are linked to permanent reductions in pulmonary function and the induction of asthma." | 1.40 | Tumor necrosis factor-related apoptosis-inducing ligand translates neonatal respiratory infection into chronic lung disease. ( Collison, AM; Essilfie, AT; Foster, PS; Hansbro, PM; Hatchwell, LM; Horvat, JC; Kim, RY; Mattes, J; Nguyen, DH; Starkey, MR; Yagita, H, 2014) |
| "Ozone (O3) is a strong oxidant in air pollution that has harmful effects on airways and exacerbates respiratory disorders." | 1.39 | Exacerbated airway toxicity of environmental oxidant ozone in mice deficient in Nrf2. ( Cho, HY; Gladwell, W; Kleeberger, SR; Yamamoto, M, 2013) |
| "HT-29 M6 colon cancer cells differentiate to a mucus-secreting phenotype in culture." | 1.35 | Cyclin D1 negatively regulates the expression of differentiation genes in HT-29 M6 mucus-secreting colon cancer cells. ( Mayo, C; Mayol, X, 2009) |
| "COPD is associated with reduced life expectancy." | 1.34 | Survival after lung volume reduction in chronic obstructive pulmonary disease: insights from small airway pathology. ( Cherniack, RM; Chu, FS; Coxson, HO; Criner, GJ; Elliott, WM; Hogg, JC; Luketich, JD; Make, BJ; Martinez, FJ; Pare, PD; Patel, SA; Rogers, RM; Sciurba, FC; Sharafkhaneh, A; Sin, DD; Tan, WC, 2007) |
| " In the present study, we have investigated the effect of a therapeutic dosing regimen with an anti-IL-13 monoclonal antibody (mAb) in a chronic mouse model of persistent asthma." | 1.33 | Therapeutic dosing with anti-interleukin-13 monoclonal antibody inhibits asthma progression in mice. ( Bugelski, PJ; Das, AM; Emmell, E; Giles-Komar, J; Griswold, DE; Lakshminarayanan, M; Li, L; Petley, T; Rafferty, P; Volk, A; Yang, G, 2005) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 3 (5.17) | 18.2507 |
| 2000's | 13 (22.41) | 29.6817 |
| 2010's | 34 (58.62) | 24.3611 |
| 2020's | 8 (13.79) | 2.80 |
| Authors | Studies |
|---|---|
| Sakai, N | 1 |
| Koya, T | 1 |
| Murai, Y | 1 |
| Tsubokawa, F | 1 |
| Tanaka, K | 1 |
| Naramoto, S | 1 |
| Aoki, A | 1 |
| Shima, K | 1 |
| Kimura, Y | 1 |
| Watanabe, S | 1 |
| Hasegawa, T | 1 |
| Kikuchi, T | 1 |
| Bustos, NA | 1 |
| Ribbeck, K | 1 |
| Wagner, CE | 1 |
| Mueller, SK | 2 |
| Wendler, O | 1 |
| Nocera, A | 1 |
| Grundtner, P | 1 |
| Schlegel, P | 1 |
| Agaimy, A | 1 |
| Iro, H | 1 |
| Bleier, BS | 2 |
| Ehre, C | 1 |
| Robinson, TE | 1 |
| Goris, ML | 1 |
| Moss, RB | 1 |
| Tian, L | 1 |
| Kan, P | 1 |
| Yilma, M | 1 |
| McCoy, KS | 1 |
| Newman, B | 1 |
| de Jong, PA | 1 |
| Long, FR | 1 |
| Brody, AS | 1 |
| Behrje, R | 1 |
| Yates, DP | 1 |
| Cornfield, DN | 1 |
| Morrison, L | 2 |
| Milroy, S | 1 |
| Lazaar, AL | 1 |
| Miller, BE | 1 |
| Donald, AC | 1 |
| Keeley, T | 1 |
| Ambery, C | 1 |
| Russell, J | 1 |
| Watz, H | 1 |
| Tal-Singer, R | 1 |
| Rao, SP | 1 |
| Rastle-Simpson, S | 1 |
| Dileepan, M | 1 |
| Sriramarao, P | 1 |
| Ikari, K | 1 |
| Tezuka, J | 1 |
| Matsumoto, T | 1 |
| Tsuji, M | 1 |
| Kawamura, M | 1 |
| Oda, T | 1 |
| Ueki, S | 1 |
| Andelid, K | 1 |
| Öst, K | 1 |
| Andersson, A | 1 |
| Mohamed, E | 1 |
| Jevnikar, Z | 1 |
| Vanfleteren, LEGW | 1 |
| Göransson, M | 1 |
| Yan, X | 1 |
| Song, Y | 1 |
| Shen, C | 1 |
| Xu, W | 1 |
| Chen, L | 1 |
| Zhang, J | 1 |
| Liu, H | 1 |
| Huang, M | 1 |
| Lai, G | 1 |
| Qian, G | 1 |
| Wang, J | 1 |
| Ye, X | 1 |
| Zheng, J | 1 |
| Bai, C | 1 |
| Innes, S | 1 |
| Iturra, PA | 1 |
| Rojas, DA | 1 |
| Pérez, FJ | 1 |
| Méndez, A | 1 |
| Ponce, CA | 1 |
| Bonilla, P | 1 |
| Bustamante, R | 1 |
| Rodríguez, H | 1 |
| Beltrán, CJ | 1 |
| Vargas, SL | 1 |
| Martínez-Rivera, C | 1 |
| Crespo, A | 1 |
| Pinedo-Sierra, C | 1 |
| García-Rivero, JL | 1 |
| Pallarés-Sanmartín, A | 1 |
| Marina-Malanda, N | 1 |
| Pascual-Erquicia, S | 1 |
| Padilla, A | 1 |
| Mayoralas-Alises, S | 1 |
| Plaza, V | 1 |
| López-Viña, A | 1 |
| Picado, C | 2 |
| Laudisi, F | 1 |
| Di Fusco, D | 1 |
| Dinallo, V | 1 |
| Stolfi, C | 1 |
| Di Grazia, A | 1 |
| Marafini, I | 1 |
| Colantoni, A | 1 |
| Ortenzi, A | 1 |
| Alteri, C | 1 |
| Guerrieri, F | 1 |
| Mavilio, M | 1 |
| Ceccherini-Silberstein, F | 1 |
| Federici, M | 1 |
| MacDonald, TT | 1 |
| Monteleone, I | 1 |
| Monteleone, G | 1 |
| Higham, A | 1 |
| Quinn, AM | 1 |
| Cançado, JED | 1 |
| Singh, D | 1 |
| Boucher, RC | 3 |
| Miranda, MCG | 1 |
| Oliveira, RP | 1 |
| Torres, L | 1 |
| Aguiar, SLF | 1 |
| Pinheiro-Rosa, N | 1 |
| Lemos, L | 1 |
| Guimarães, MA | 1 |
| Reis, D | 1 |
| Silveira, T | 1 |
| Ferreira, Ê | 1 |
| Moreira, TG | 1 |
| Cara, DC | 1 |
| Maioli, TU | 1 |
| Kelsall, BL | 1 |
| Carlos, D | 1 |
| Faria, AMC | 1 |
| Miyake, MM | 1 |
| Workman, AD | 1 |
| Nocera, AL | 1 |
| Wu, D | 1 |
| Finn, K | 1 |
| Amiji, MM | 1 |
| Cho, HY | 1 |
| Gladwell, W | 1 |
| Yamamoto, M | 1 |
| Kleeberger, SR | 1 |
| Montella, S | 1 |
| Mollica, C | 1 |
| Finocchi, A | 1 |
| Pession, A | 1 |
| Pietrogrande, MC | 1 |
| Trizzino, A | 1 |
| Ranucci, G | 1 |
| Maglione, M | 1 |
| Giardino, G | 1 |
| Salvatore, M | 1 |
| Santamaria, F | 1 |
| Pignata, C | 1 |
| Starkey, MR | 1 |
| Nguyen, DH | 1 |
| Essilfie, AT | 1 |
| Kim, RY | 1 |
| Hatchwell, LM | 1 |
| Collison, AM | 1 |
| Yagita, H | 1 |
| Foster, PS | 1 |
| Horvat, JC | 1 |
| Mattes, J | 1 |
| Hansbro, PM | 1 |
| Zhang, Y | 1 |
| Jiang, Y | 1 |
| Sun, C | 1 |
| Wang, Q | 1 |
| Yang, Z | 1 |
| Pan, X | 1 |
| Zhu, M | 1 |
| Xiao, W | 1 |
| Hill, DB | 1 |
| Vasquez, PA | 1 |
| Mellnik, J | 1 |
| McKinley, SA | 1 |
| Vose, A | 1 |
| Mu, F | 1 |
| Henderson, AG | 1 |
| Donaldson, SH | 1 |
| Alexis, NE | 1 |
| Forest, MG | 1 |
| Kerr, SC | 1 |
| Carrington, SD | 1 |
| Oscarson, S | 1 |
| Gallagher, ME | 1 |
| Solon, M | 1 |
| Yuan, S | 1 |
| Ahn, JN | 1 |
| Dougherty, RH | 1 |
| Finkbeiner, WE | 1 |
| Peters, MC | 1 |
| Fahy, JV | 1 |
| Wong, EH | 1 |
| Porter, JD | 1 |
| Edwards, MR | 1 |
| Johnston, SL | 1 |
| Fishman, JE | 1 |
| Levy, G | 1 |
| Alli, V | 1 |
| Zheng, X | 1 |
| Mole, DJ | 1 |
| Deitch, EA | 1 |
| Freitas, DA | 1 |
| Dias, FA | 1 |
| Chaves, GS | 1 |
| Ferreira, GM | 1 |
| Ribeiro, CT | 1 |
| Guerra, RO | 1 |
| Mendonça, KM | 1 |
| Allinson, JP | 1 |
| Hardy, R | 1 |
| Donaldson, GC | 1 |
| Shaheen, SO | 1 |
| Kuh, D | 1 |
| Wedzicha, JA | 1 |
| Locke, LW | 1 |
| Myerburg, MM | 1 |
| Weiner, DJ | 1 |
| Markovetz, MR | 1 |
| Parker, RS | 1 |
| Muthukrishnan, A | 1 |
| Weber, L | 1 |
| Czachowski, MR | 1 |
| Lacy, RT | 1 |
| Pilewski, JM | 1 |
| Corcoran, TE | 1 |
| Franchini, ML | 1 |
| Athanazio, R | 1 |
| Amato-Lourenço, LF | 1 |
| Carreirão-Neto, W | 1 |
| Saldiva, PH | 1 |
| Lorenzi-Filho, G | 1 |
| Rubin, BK | 2 |
| Nakagawa, NK | 1 |
| McCann, JR | 1 |
| Mason, SN | 1 |
| Auten, RL | 1 |
| St Geme, JW | 1 |
| Seed, PC | 1 |
| Miyasaka, T | 1 |
| Okuyama-Dobashi, K | 1 |
| Masuda, C | 1 |
| Iwami, S | 1 |
| Sato, M | 1 |
| Mizoguchi, H | 1 |
| Kawano, T | 1 |
| Ohkawara, Y | 1 |
| Sakurada, S | 1 |
| Takayanagi, M | 1 |
| Ohno, I | 1 |
| Yokota, M | 1 |
| Tamachi, T | 1 |
| Yokoyama, Y | 1 |
| Maezawa, Y | 1 |
| Takatori, H | 1 |
| Suto, A | 1 |
| Suzuki, K | 1 |
| Hirose, K | 1 |
| Takeda, K | 1 |
| Nakajima, H | 1 |
| Schmitz, JM | 1 |
| Durham, CG | 1 |
| Ho, SB | 1 |
| Lorenz, RG | 1 |
| Mayo, C | 1 |
| Mayol, X | 1 |
| Zlosnik, JE | 1 |
| Costa, PS | 1 |
| Brant, R | 1 |
| Mori, PY | 1 |
| Hird, TJ | 1 |
| Fraenkel, MC | 1 |
| Wilcox, PG | 1 |
| Davidson, AG | 1 |
| Speert, DP | 1 |
| Wielpütz, MO | 1 |
| Eichinger, M | 1 |
| Zhou, Z | 1 |
| Leotta, K | 1 |
| Hirtz, S | 1 |
| Bartling, SH | 1 |
| Semmler, W | 1 |
| Kauczor, HU | 1 |
| Puderbach, M | 1 |
| Mall, MA | 1 |
| Sellamuthu, R | 1 |
| Umbright, C | 1 |
| Roberts, JR | 1 |
| Cumpston, A | 1 |
| McKinney, W | 1 |
| Chen, BT | 1 |
| Frazer, D | 1 |
| Li, S | 1 |
| Kashon, M | 1 |
| Joseph, P | 1 |
| Petersen, BC | 1 |
| Lukacs, NW | 1 |
| Tam, A | 1 |
| Sin, DD | 2 |
| Zarei, S | 1 |
| Mirtar, A | 1 |
| Rohwer, F | 1 |
| Conrad, DJ | 1 |
| Theilmann, RJ | 1 |
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| Criner, GJ | 2 |
| Tang, F | 1 |
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| Zhang, PH | 1 |
| Zhao, QM | 1 |
| Zhan, L | 1 |
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| Wu, XM | 1 |
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| Fang, LQ | 1 |
| Wei, MT | 1 |
| Wang, HW | 1 |
| Cao, WC | 1 |
| Yang, G | 1 |
| Li, L | 1 |
| Volk, A | 1 |
| Emmell, E | 1 |
| Petley, T | 1 |
| Giles-Komar, J | 1 |
| Rafferty, P | 1 |
| Lakshminarayanan, M | 1 |
| Griswold, DE | 1 |
| Bugelski, PJ | 1 |
| Das, AM | 1 |
| Ohta, Y | 1 |
| Kamiya, Y | 1 |
| Imai, Y | 1 |
| Arisawa, T | 1 |
| Nakano, H | 1 |
| Ko, FW | 1 |
| Diba, C | 1 |
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| Matin, D | 1 |
| De Rose, V | 1 |
| Jeffery, PK | 1 |
| Hogg, JC | 1 |
| Chu, FS | 1 |
| Tan, WC | 1 |
| Patel, SA | 1 |
| Pare, PD | 1 |
| Martinez, FJ | 1 |
| Rogers, RM | 1 |
| Make, BJ | 1 |
| Cherniack, RM | 1 |
| Sharafkhaneh, A | 1 |
| Luketich, JD | 1 |
| Coxson, HO | 1 |
| Elliott, WM | 1 |
| Sciurba, FC | 1 |
| Brusasco, V | 1 |
| Crimi, E | 1 |
| Pellegrino, R | 1 |
| Ramzan, PH | 1 |
| Parkin, TD | 1 |
| Shepherd, MC | 1 |
| Mikami, M | 1 |
| Llewellyn-Jones, CG | 1 |
| Bayley, D | 1 |
| Hill, SL | 1 |
| Stockley, RA | 1 |
| Cockrill, BA | 1 |
| Hales, CA | 1 |
| Sethi, S | 1 |
| Kalk, WW | 1 |
| Mansour, K | 1 |
| Vissink, A | 1 |
| Spijkervet, FK | 1 |
| Bootsma, H | 1 |
| Kallenberg, CG | 1 |
| Roodenburg, JL | 1 |
| Nieuw Amerongen, AV | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital[NCT00717873] | 105 participants (Actual) | Interventional | 2008-06-30 | Completed | |||
| Timing of Hypertonic Saline Inhalation Relative to Airways Clearance in Cystic Fibrosis[NCT01753869] | 14 participants (Actual) | Interventional | 2012-12-31 | Terminated (stopped due to Challenges with recruitment) | |||
| Randomised, Double-Blind (Sponsor Open), Placebo-Controlled, Multicentre, Dose Ranging Study to Evaluate the Efficacy and Safety of Danirixin Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Participants With Chronic Obstructiv[NCT03034967] | Phase 2 | 614 participants (Actual) | Interventional | 2017-04-25 | Completed | ||
| Comparison of Resistive Breathing Versus Inspiratory Hold Technique in Patients With Chronic Bronchitis[NCT05533931] | 26 participants (Anticipated) | Interventional | 2022-09-30 | Not yet recruiting | |||
| Evaluation of the Short-term Use of Selected PEP and OPEP Devices in Cystic Fibrosis Patients During an Exacerbation of the Disease[NCT05801952] | 60 participants (Anticipated) | Interventional | 2020-01-01 | Recruiting | |||
| "Validation of a Questionnaire to Assess Bronchial Mucus Hypersecretion in Asthmatic Patients. Questionnaire T-sec (Secretion Test)."[NCT05546645] | 100 participants (Anticipated) | Observational | 2023-10-01 | Recruiting | |||
| Alteration of Intestinal Microflora and Efficacy and Safety of Fecal Microbiota Transplantation for Severe Acute Pancreatitis[NCT03015467] | Phase 1/Phase 2 | 80 participants (Anticipated) | Interventional | 2016-12-31 | Recruiting | ||
| Repeatability and Response Study of Absorptive Clearance Scans[NCT01887197] | Phase 1 | 24 participants (Actual) | Interventional | 2013-06-30 | Completed | ||
| Absorptive Clearance in the Cystic Fibrosis Airway[NCT00541190] | 21 participants (Actual) | Interventional | 2007-10-31 | Completed | |||
| Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis[NCT01223183] | Phase 1 | 20 participants (Actual) | Interventional | 2010-09-30 | Completed | ||
| Imaging Airway Liquid Absorption in Cystic Fibrosis[NCT01486199] | 20 participants (Actual) | Interventional | 2011-10-31 | Completed | |||
| The Efficacy of the AIRVO Warm Humidifier as an Add on to Oxygen Therapy as Well as Stand-alone Therapy in Patients With Respiratory Insufficiency[NCT03081650] | 30 participants (Anticipated) | Interventional | 2016-08-16 | Recruiting | |||
| Effects of Long-term Dry and Humidified Low-flow Oxygen Via Nasal Cannula on Nasal Mucociliary Clearance, Mucus Properties, Inflammation and Airway Symptoms in Patients[NCT02515786] | Phase 1/Phase 2 | 19 participants (Anticipated) | Interventional | 2013-01-31 | Active, not recruiting | ||
| Comparison Of Blow Bottle Positive Expiratory Pressure (BBPEP) Versus Acapella on Oxygenation ,Peak Expiratory Flow Rate (PEFR) Among Patient With Chronic Bronchitis[NCT06086730] | 36 participants (Actual) | Interventional | 2023-07-20 | Completed | |||
| The Effect of Beclomethasone/Formoterol in Extra-fine Formulation on Quality of Life and Dyspnea is Associated to the Improvement in Small Airway Dysfunction in COPD Patients. A Pilot Study (IOSCOPD20161102)[NCT04421742] | 43 participants (Actual) | Observational | 2017-05-31 | Completed | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
an average of 10 days (NCT00717873)
Timeframe: Admission to Discharge
| Intervention | days (Mean) |
|---|---|
| HFCWO Arm | 2.95 |
| CPT Arm | 5.45 |
E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented. (NCT03034967)
Timeframe: Baseline and Month 6
| Intervention | Scores on a scale (Mean) |
|---|---|
| Placebo | -0.82 |
| Danirixin 5 mg | -0.69 |
| Danirixin 10 mg | -0.41 |
| Danirixin 25 mg | -0.15 |
| Danirixin 35 mg | -0.10 |
| Danirixin 50 mg | -0.09 |
E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented. (NCT03034967)
Timeframe: Baseline and Month 6
| Intervention | Scores on a scale (Mean) |
|---|---|
| Placebo | -0.36 |
| Danirixin 5 mg | -0.35 |
| Danirixin 10 mg | -0.34 |
| Danirixin 25 mg | -0.34 |
| Danirixin 35 mg | -0.34 |
| Danirixin 50 mg | -0.34 |
E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented. (NCT03034967)
Timeframe: Baseline and Month 6
| Intervention | Scores on a scale (Mean) |
|---|---|
| Placebo | -0.83 |
| Danirixin 5 mg | -0.79 |
| Danirixin 10 mg | -0.67 |
| Danirixin 25 mg | -0.46 |
| Danirixin 35 mg | -0.40 |
| Danirixin 50 mg | -0.37 |
E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range [0-17]), RS-cough and sputum (RS-CSP comprised of 3 items, score range [0-11]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range [0-12]). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Per protocol population included all participants from the mITT population who did not have a protocol deviation considered to impact efficacy. Posterior mean change and standard deviation has been presented. (NCT03034967)
Timeframe: Baseline and Month 6
| Intervention | Scores on a scale (Mean) |
|---|---|
| Placebo | -2.11 |
| Danirixin 5 mg | -1.93 |
| Danirixin 10 mg | -1.47 |
| Danirixin 25 mg | -0.87 |
| Danirixin 35 mg | -0.76 |
| Danirixin 50 mg | -0.71 |
EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery. Duration of EXACT events has been reported. (NCT03034967)
Timeframe: Up to Day 168
| Intervention | Days (Mean) |
|---|---|
| Placebo | 45.3 |
| Danirixin 5 mg | 11.6 |
| Danirixin 10 mg | 45.8 |
| Danirixin 25 mg | 25.5 |
| Danirixin 35 mg | 17.6 |
| Danirixin 50 mg | 18.7 |
The duration of HCRU exacerbation were determined. The duration of the exacerbation was calculated as (exacerbation resolution date or date of death - exacerbation onset date + 1). For exacerbations which were not resolved but where the participant later died from other causes, the duration was calculated using date of death as the end date of the event. (NCT03034967)
Timeframe: Up to Day 196
| Intervention | Days (Mean) |
|---|---|
| Placebo | 10.3 |
| Danirixin 5 mg | 12.3 |
| Danirixin 10 mg | 12.9 |
| Danirixin 25 mg | 14.0 |
| Danirixin 35 mg | 10.7 |
| Danirixin 50 mg | 14.2 |
E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. E-RS is intended to capture information related to the respiratory symptoms of COPD, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS has a scoring range of 0-40; higher scores indicate more severe symptoms. Response is defined as an E-RS: COPD total score of 2 units below baseline or lower. Non-response is defined as an E-RS: COPD total score higher than 2 units below Baseline. (NCT03034967)
Timeframe: Month 6
| Intervention | Participants (Number) |
|---|---|
| Placebo | 33 |
| Danirixin 5 mg | 48 |
| Danirixin 10 mg | 33 |
| Danirixin 25 mg | 30 |
| Danirixin 35 mg | 29 |
| Danirixin 50 mg | 32 |
Spirometric analysis was done to determine percent predicted FEVI at screening. FEV1 is forced expiratory volume in one second. Percent predicted FEV1 is defined as the percent FEV1 of the participant is divided by average FEV1 percent in the population of any person similar age, sex and body composition. (NCT03034967)
Timeframe: At Screening
| Intervention | Percent predicted FEV1 (Mean) |
|---|---|
| Placebo | 58.98 |
| Danirixin 5 mg | 56.75 |
| Danirixin 10 mg | 56.62 |
| Danirixin 25 mg | 56.84 |
| Danirixin 35 mg | 57.51 |
| Danirixin 50 mg | 57.84 |
EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery. (NCT03034967)
Timeframe: Up to Day 168
| Intervention | Scores on a scale (Mean) |
|---|---|
| Placebo | 22.1 |
| Danirixin 5 mg | 26.7 |
| Danirixin 10 mg | 22.9 |
| Danirixin 25 mg | 28.6 |
| Danirixin 35 mg | 25.0 |
| Danirixin 50 mg | 26.4 |
Blood samples were collected at indicated timepoints for the analysis of phamacokinetic parameter. All participants in the PK population who had at least 1 non-missing PK assessment obtained and analyzed whilst on treatment with danirixin from a dry blood spot sample and corresponding wet whole blood sample were included in Pharmacokinetic population. (NCT03034967)
Timeframe: Days 1 and 168
| Intervention | Hour*nanogram per milliliter (Geometric Mean) | |
|---|---|---|
| Day 1, n=17, 19, 24, 26, 19 | Day 168, n=14, 13, 17, 18, 16 | |
| Danirixin 10 mg | 1373.1 | 1701.8 |
| Danirixin 25 mg | 3851.5 | 4170.1 |
| Danirixin 35 mg | 5485.1 | 7682.6 |
| Danirixin 5 mg | 543.0 | 752.1 |
| Danirixin 50 mg | 8073.4 | 11538.0 |
The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants were completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment) with a total scoring range of 0-40; higher scores indicate worse health status. A CAT score was calculated by summing the non-missing scores on the eight items. Individual items are scored from 0 to 5 with a total score range from 0 - 40, higher scores indicate greater disease impact. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented. (NCT03034967)
Timeframe: Baseline, Days 84 and 168
| Intervention | Scores on a scale (Mean) | |
|---|---|---|
| Day 84, n=89, 97, 92, 89, 88, 85 | Day 168, n=84, 94, 86, 87, 85, 83 | |
| Danirixin 10 mg | -0.63 | -1.23 |
| Danirixin 25 mg | -0.55 | -0.97 |
| Danirixin 35 mg | -1.51 | -1.56 |
| Danirixin 5 mg | -0.86 | -1.39 |
| Danirixin 50 mg | -0.36 | -1.32 |
| Placebo | -2.02 | -1.39 |
Spirometric analysis was done to determine FEV1. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented. (NCT03034967)
Timeframe: Baseline, Days 84 and 168
| Intervention | Liters (Least Squares Mean) | |
|---|---|---|
| Day 84, n=94, 99, 98, 97, 92, 93 | Day 168, n=88, 97, 90, 90, 88, 86 | |
| Danirixin 10 mg | -0.029 | -0.033 |
| Danirixin 25 mg | -0.018 | -0.058 |
| Danirixin 35 mg | -0.027 | -0.012 |
| Danirixin 5 mg | -0.031 | -0.043 |
| Danirixin 50 mg | 0.027 | -0.011 |
| Placebo | 0.016 | -0.016 |
Spirometric analysis was done to determine FEV1 and FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. (NCT03034967)
Timeframe: Baseline, Days 84 and 168
| Intervention | Ratio of FEV1/FVC (Mean) | |
|---|---|---|
| Day 84, n=94, 99, 98, 97, 92, 93 | Day 168, n=88, 97, 90, 90, 88, 86 | |
| Danirixin 10 mg | -0.000 | 0.003 |
| Danirixin 25 mg | -0.013 | -0.015 |
| Danirixin 35 mg | -0.000 | 0.002 |
| Danirixin 5 mg | -0.001 | -0.003 |
| Danirixin 50 mg | 0.014 | -0.002 |
| Placebo | -0.003 | -0.007 |
Spirometric analysis was done to determine FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented. (NCT03034967)
Timeframe: Baseline, Days 84 and 168
| Intervention | Liters (Least Squares Mean) | |
|---|---|---|
| Day 84, n=94, 99, 98, 97, 92, 93 | Day 168, n=88, 97, 90, 90, 88, 86 | |
| Danirixin 10 mg | -0.043 | -0.043 |
| Danirixin 25 mg | 0.027 | -0.024 |
| Danirixin 35 mg | -0.049 | -0.036 |
| Danirixin 5 mg | -0.054 | -0.079 |
| Danirixin 50 mg | 0.014 | -0.016 |
| Placebo | 0.024 | -0.011 |
The SGRQ-C consists of 40 items aggregated into 3 component scores: Symptoms, Activity, Impacts, and a Total score. Each response to a question is assigned a weight. Component scores are calculated by summing the weights from all positive items in that component, dividing by the sum of weights for all items in that component, and multiplying this number by 100. Component scores could range from 0-100, with a higher component score indicating greater disease burden. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented. (NCT03034967)
Timeframe: Baseline, Days 84 and 168
| Intervention | Scores on a scale (Mean) | |
|---|---|---|
| Day 84, n=93, 97, 94, 96, 91, 90 | Day 168, n=85, 96, 86, 90, 86, 85 | |
| Danirixin 10 mg | -1.31 | -4.19 |
| Danirixin 25 mg | -3.19 | -4.94 |
| Danirixin 35 mg | -2.83 | -4.12 |
| Danirixin 5 mg | -3.63 | -3.44 |
| Danirixin 50 mg | -2.48 | -3.41 |
| Placebo | -3.79 | -4.11 |
The mean number of puffs of rescue per day was calculated over the same time periods and using the same assumptions as rescue use via diary. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented. (NCT03034967)
Timeframe: Baseline, Months 1, 2, 3, 4, 5 and 6
| Intervention | Puffs per day (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Month 1, n=100, 102, 100, 102, 98, 99 | Month 2, n=96, 100, 98, 97, 98, 96 | Month 3, n=95, 100, 95, 97, 94, 92 | Month 4, n=92, 98, 92, 97, 90, 90 | Month 5, n=88, 97, 88, 94, 87, 87 | Month 6, n=86, 95, 88, 91, 85, 86 | |
| Danirixin 10 mg | 0.28 | 0.18 | 0.21 | 0.27 | 0.19 | 0.10 |
| Danirixin 25 mg | 0.15 | 0.35 | 0.25 | 0.21 | 0.25 | 0.15 |
| Danirixin 35 mg | -0.03 | 0.07 | 0.07 | -0.04 | -0.06 | 0.04 |
| Danirixin 5 mg | 0.36 | 0.42 | 0.29 | 0.27 | 0.17 | 0.21 |
| Danirixin 50 mg | 0.28 | 0.33 | 0.27 | 0.44 | 0.29 | 0.28 |
| Placebo | 0.00 | -0.22 | -0.18 | -0.18 | -0.16 | -0.17 |
Blood samples were collected from the participants for the analysis of pharmacokinetic parameter. (NCT03034967)
Timeframe: Days 1 and 168
| Intervention | Nanogram per milliliter (Geometric Mean) | |
|---|---|---|
| Day 1, n=17, 19, 24, 26, 19 | Day 168, n=14, 13, 17, 18, 16 | |
| Danirixin 10 mg | 343.1 | 357.3 |
| Danirixin 25 mg | 1028.8 | 821.2 |
| Danirixin 35 mg | 1386.2 | 1695.0 |
| Danirixin 5 mg | 164.9 | 171.9 |
| Danirixin 50 mg | 2119.1 | 2390.5 |
Blood samples were collected from the participants for the analysis of blood pharmacokinetic concentration-time data. All participants in the mITT population who had at least 1 non-missing Pharmacokinetic assessment obtained and analyzed whilst on treatment with danirixin were included Pharmacokinetic population. (NCT03034967)
Timeframe: Pre-dose on Days 1, 56, 84 and 168; 0.5, 1, 2, 4, 6, 8, 10, 12 hours post-dose on Days 1 and 168
| Intervention | Nanogram per milliliter (Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1, Pre-dose, n=97, 99, 102, 102, 100 | Day 1, 0.5 hour, n=16, 19, 24, 26, 19 | Day 1, 1 hour, n=16, 18, 24, 26, 19 | Day 1, 2 hours, n=16, 19, 24, 26, 19 | Day 1, 4 hours, n=16, 19, 24, 26, 19 | Day 1, 6 hours, n=16, 19, 24, 26, 19 | Day 1, 8 hours, n=15, 19, 24, 26, 19 | Day 1, 10 hours, n=16, 18, 22, 26, 19 | Day 1, 12 hours, n=16, 16, 21, 26, 18 | Day 56, Pre-dose, n=94, 91, 94, 95, 92 | Day 84, Pre-dose, n=97, 94, 96, 91, 90 | Day 168, Pre-dose, n=92, 85, 89, 85, 84 | Day 168, 0.5 hours, n=14, 12, 17, 18, 16 | Day 168, 1 hours, n=14, 13, 17, 18, 16 | Day 168, 2 hours, n=14, 13, 17, 18, 16 | Day 168, 4 hours, n=13, 11, 16, 18, 16 | Day 168, 6 hours, n=13, 13, 16, 18, 15 | Day 168, 8 hours, n=13, 13, 17, 18, 15 | Day 168, 10 hours, n=13, 12, 17, 18, 15 | Day 168, 12 hours, n=13, 12, 17, 18, 15 | |
| Danirixin 10 mg | 0.4 | 210.4 | 343.3 | 277.7 | 165.3 | 100.6 | 67.8 | 61.5 | 74.7 | 91.8 | 76.2 | 99.5 | 248.3 | 314.0 | 331.9 | 190.9 | 135.5 | 102.6 | 76.6 | 73.1 |
| Danirixin 25 mg | 0.3 | 730.5 | 822.0 | 707.7 | 401.5 | 270.0 | 213.8 | 265.0 | 188.2 | 252.3 | 212.3 | 217.9 | 530.5 | 681.2 | 574.7 | 452.8 | 289.6 | 245.1 | 193.9 | 169.7 |
| Danirixin 35 mg | 17.2 | 976.1 | 1183.5 | 1011.2 | 591.5 | 371.5 | 325.8 | 274.5 | 232.8 | 372.1 | 342.8 | 350.7 | 1449.5 | 1590.3 | 1045.2 | 805.0 | 554.8 | 444.9 | 380.2 | 481.2 |
| Danirixin 5 mg | 2.1 | 86.7 | 148.3 | 115.3 | 59.2 | 34.4 | 26.1 | 42.5 | 87.2 | 53.2 | 50.2 | 41.2 | 147.7 | 162.1 | 127.4 | 90.5 | 55.6 | 41.5 | 42.4 | 42.2 |
| Danirixin 50 mg | 3.9 | 1331.0 | 1846.2 | 1472.8 | 904.6 | 594.9 | 428.2 | 302.3 | 459.3 | 572.0 | 484.3 | 459.5 | 1635.6 | 1725.4 | 1736.6 | 1459.9 | 960.4 | 760.8 | 715.0 | 662.4 |
A participant was considered as a responder according to CAT score if their change from Baseline CAT score 2.0 units below Baseline or lower. (NCT03034967)
Timeframe: Day 84 and Day 168
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Day 84, n=89, 97, 92, 89, 88, 85 | Day 168, n=84, 94, 86, 87, 85, 83 | |
| Danirixin 10 mg | 38 | 39 |
| Danirixin 25 mg | 37 | 42 |
| Danirixin 35 mg | 43 | 46 |
| Danirixin 5 mg | 44 | 44 |
| Danirixin 50 mg | 36 | 44 |
| Placebo | 46 | 41 |
EXACT is a 14 item patient reported outcome (PRO) instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Events were categorized as recovered, censored, or persistent worsening. Number of EXACT events per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and >=2= participants in each treatment group who experienced 2 or more events. (NCT03034967)
Timeframe: Up to Day 196
| Intervention | Events (Number) | ||
|---|---|---|---|
| 0 | 1 | >=2 | |
| Danirixin 10 mg | 92 | 7 | 1 |
| Danirixin 25 mg | 92 | 9 | 2 |
| Danirixin 35 mg | 86 | 10 | 4 |
| Danirixin 5 mg | 92 | 6 | 4 |
| Danirixin 50 mg | 86 | 10 | 3 |
| Placebo | 92 | 9 | 0 |
Participants with moderate or severe COPD exacerbations, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness analyzed. Mild exacerbations are defined as exacerbations that did not require treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, Emergency Room [ER] visit or resulting in death). Moderate exacerbations are defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, ER visit or resulting in death). Severe exacerbations are defined as exacerbations that required hospitalization, ER visit or resulted in death. Number of moderate or severe HCRU exacerbations per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and >=2= participants in each treatment group who experienced 2 or more events. (NCT03034967)
Timeframe: Up to Day 196
| Intervention | Exacerbations per participant (Number) | ||
|---|---|---|---|
| 0 | 1 | >=2 | |
| Danirixin 10 mg | 61 | 23 | 16 |
| Danirixin 25 mg | 63 | 28 | 12 |
| Danirixin 35 mg | 55 | 30 | 15 |
| Danirixin 5 mg | 51 | 34 | 17 |
| Danirixin 50 mg | 50 | 36 | 13 |
| Placebo | 66 | 28 | 7 |
AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE. (NCT03034967)
Timeframe: Up to Day 196
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Any AE | Any SAE | |
| Danirixin 10 mg | 69 | 13 |
| Danirixin 25 mg | 68 | 10 |
| Danirixin 35 mg | 63 | 7 |
| Danirixin 5 mg | 63 | 7 |
| Danirixin 50 mg | 71 | 11 |
| Placebo | 63 | 8 |
"Blood samples were collected from participants for analysis of following chemistry parameters with PCI low and high values: Alanine aminotransferase (ALT) International units per liter (IU/L) (High => 3x ULN), Alkaline phosphatase (ALP) (IU/L) (High ≥ 2x ULN); Aspartate aminotransferase (AST) (IU/L) (High=> 3x ULN); Bilirubin micromole per liter (umol/L) (High ≥ 2x ULN); Calcium millimole per liter (mmol/L) (Low 0.85x, high 1.08x), Chloride (mmol/L) (Low 0.90x, high 1.10x), Creatinine (umol/L) (High 1.30x), Direct bilirubin (umol/L) (High ≥ 2x ULN), Glucose (mmol/L) (Low <0.6x, high >4x), Potassium (mmol/L) (Low 0.75x, high 1.30x); Protein (g/L) (High 1.25x), Sodium (mmol/L) (Low 0.80x, high 1.15x), Multipliers are identified by x, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI." (NCT03034967)
Timeframe: Up to Day 196
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ALT, No change,n=99,102,102,102,101,100 | ALT, High, n=99,102,102,102,101,100 | ALP, No change,n=99,102,102,102,101,100 | ALP, High, n=99,102,102,102,101,100 | AST, No change,n=99,102,102,102,101,100 | AST, High, n=99,102,102,102,101,100 | Bilirubin, No change, n=99,102,102,102,101,100 | Bilirubin, High, n=99, 102,102,102,101,100 | Calcium, Low, n=96,102,101,101,101,99 | Calcium, No change, n=96,102,101,101,101,99 | Calcium, High, n=96,102,101,101,101,99 | CO2, Low, n=96,102,101,101,101,99 | CO2, No change, n=96,102,101,101,101,99 | CO2, High, n=96,102,101,101,101,99 | Chloride, Low, n=96,102,101,101,101,99 | Chloride, No change, n=96,102,101,101,101,99 | Chloride, High, n=96,102,101,101,101,99 | Creatinine, No change, n=96,102,101,101,101,99 | Creatinine, High, n=96, 102, 101, 101, 101, 99 | Direct bilirubin,NoChange,n=99,102,102,102,101,100 | Direct bilirubin,High,n=99,102,102,102,101,100 | Glucose, Low, n=96, 102, 101, 101, 101, 99 | Glucose, No change, n=96, 102, 101, 101, 101, 99 | Glucose, High, n=96, 102, 101, 101, 101, 99 | Potassium, Low, n=96, 102, 101, 101, 101, 99 | Potassium, No change, n=96, 102, 101, 101, 101, 99 | Potassium, High, n=96, 102, 101, 101, 101, 99 | Protein, No change, n=99, 102, 102, 102, 101, 100 | Protein, High, n=99, 102, 102, 102, 101, 100 | Sodium, Low, n=96, 102, 101, 101, 101, 99 | Sodium, No change, n=96, 102, 101, 101, 101, 99 | Sodium, High, n=96, 102, 101, 101, 101, 99 | Urea, Low, n=96, 102, 101, 101, 101, 99 | Urea, No change, n=96, 102, 101, 101, 101, 99 | Urea, High, n=96, 102, 101, 101, 101, 99 | Bilirubin/ALT,No change,n=99,102,102,102,101,100 | Bilirubin/ALT, High,n=99,102,102,102,101,100 | |
| Danirixin 10 mg | 101 | 1 | 102 | 0 | 101 | 1 | 102 | 0 | 0 | 101 | 0 | 2 | 99 | 0 | 0 | 101 | 0 | 99 | 2 | 102 | 0 | 0 | 101 | 0 | 0 | 101 | 0 | 102 | 0 | 0 | 101 | 0 | 0 | 101 | 0 | 102 | 0 |
| Danirixin 25 mg | 102 | 0 | 102 | 0 | 102 | 0 | 102 | 0 | 0 | 101 | 0 | 1 | 99 | 1 | 0 | 101 | 0 | 99 | 2 | 102 | 0 | 0 | 101 | 0 | 0 | 101 | 0 | 102 | 0 | 0 | 101 | 0 | 0 | 100 | 1 | 102 | 0 |
| Danirixin 35 mg | 101 | 0 | 101 | 0 | 101 | 0 | 101 | 0 | 0 | 101 | 0 | 0 | 101 | 0 | 0 | 101 | 0 | 99 | 2 | 101 | 0 | 0 | 101 | 0 | 0 | 101 | 0 | 101 | 0 | 0 | 101 | 0 | 0 | 101 | 0 | 101 | 0 |
| Danirixin 5 mg | 102 | 0 | 102 | 0 | 102 | 0 | 101 | 1 | 0 | 102 | 0 | 0 | 102 | 0 | 0 | 102 | 0 | 100 | 2 | 102 | 0 | 0 | 102 | 0 | 0 | 102 | 0 | 102 | 0 | 0 | 102 | 0 | 0 | 101 | 1 | 102 | 0 |
| Danirixin 50 mg | 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 0 | 99 | 0 | 1 | 98 | 0 | 0 | 99 | 0 | 99 | 0 | 100 | 0 | 0 | 99 | 0 | 0 | 99 | 0 | 100 | 0 | 0 | 99 | 0 | 0 | 98 | 1 | 100 | 0 |
| Placebo | 99 | 0 | 99 | 0 | 99 | 0 | 99 | 0 | 0 | 96 | 0 | 1 | 94 | 1 | 0 | 96 | 0 | 94 | 2 | 98 | 1 | 0 | 96 | 0 | 0 | 96 | 0 | 99 | 0 | 0 | 96 | 0 | 0 | 96 | 0 | 99 | 0 |
"Blood samples were collected from participants for analysis of following hematology parameters with PCI low and high values: Basophils % (High 5.00x), Eosinophils % (High 2.00x), Mean corpuscular hemoglobin concentration (MCHC) gram per deciliter (g/dL) (Low 0.85x, high 1.10x), Mean corpuscular hemoglobin (MCH) picograms (pg) (Low 0.85x, high 1.20x), Mean corpuscular volume (MCV) femtoliter (fL) (low 0.25x, high 2.00x), Erythrocytes (Ery.)(10^12cells/L) (Low 0.93x, high 1.07x), Hematocrit (Ratio of 1) (Low 0.50x, high 0.50x), Hemoglobin gram per liter (g/L) (Low 0.85x, high 1.20x), Leukocytes (x10^9/L) (Low 0.70x, high 1.60x), Lymphocytes % (Low 0.80x, high 1.20x), Monocytes % (Low 0.80x, high 1.60x), Neutrophils % (Low 0.65x, high 1.50x), Platelets (x10^9cells/L) (Low 0.90x, high 1.10x). Multipliers are identified by x, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI." (NCT03034967)
Timeframe: Up to Day 196
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Basophils, No change, n=97, 102, 101, 101, 101, 99 | Basophils, High, n=97, 102, 101, 101, 101, 99 | Eosinophils,No change,n=97,102,101,101,101,99 | Eosinophils, High, n=97, 102, 101, 101, 101, 99 | Ery. MCHC, Low, n=97, 102, 101, 101, 102, 99 | Ery. MCHC,No change,n=97,102,101,101,102,99 | Ery. MCHC, High, n=97, 102, 101, 101, 102, 99 | Ery. MCH, Low, n=97, 102, 101, 101, 102, 99 | Ery. MCH, No Change, n=97, 102, 101, 101, 102, 99 | Ery. MCH, High, n=97, 102, 101, 101, 102, 99 | Ery. MCV, Low, n=97, 102, 101, 101, 102, 99 | Ery. MCV, No Change, n=97, 102, 101, 101, 102, 99 | Ery. MCV, High, n=97, 102, 101, 101, 102, 99 | Erythrocytes, Low, n=97, 102, 101, 101, 102, 99 | Erythrocytes, No change,n=97,102,101,101,102,99 | Erythrocytes. High, n=97, 102, 101, 101, 102, 99 | Hematocrit, Low, n=97, 102, 101, 101, 102, 99 | Hematocrit, No Change, n=97,102,101,101,102,99 | Hematocrit, High, n=97, 102, 101, 101, 102, 99 | Hemoglobin, Low, n=97, 102, 101, 101, 102, 99 | Hemoglobin, No change, n=97,102,101,101,102,99 | Hemoglobin, High, n=97, 102, 101, 101, 102, 99 | Leukocytes, Low, n=97, 102, 101, 101, 102, 99 | Leukocytes, No change, n=97,102,101,101,102,99 | Leukocytes, High, n=97, 102, 101, 101, 102, 99 | Lymphocytes, Low, n=97, 102, 101, 101, 101, 99 | Lymphocytes, No change, n=97,102,101,101,101,99 | Lymphocytes, High, n=97, 102, 101, 101, 101, 99 | Monocytes, No change, n=97, 102, 101, 101, 101, 99 | Monocytes, High, n=97, 102, 101, 101, 101, 99 | Neutrophils, Low, n=97, 102, 101, 101, 101, 99 | Neutrophils, No change, n=97,102,101,101,101,99 | Neutrophils, High, n=97, 102, 101, 101, 101, 99 | Platelets, Low, n=97, 102, 101, 101, 101, 99 | Platelets, No change, n=97, 102, 101, 101, 101, 99 | Platelets, High, n=97, 102, 101, 101, 101, 99 | |
| Danirixin 10 mg | 101 | 0 | 101 | 0 | 0 | 101 | 0 | 0 | 101 | 0 | 0 | 101 | 0 | 3 | 97 | 1 | 0 | 101 | 0 | 2 | 99 | 0 | 0 | 101 | 0 | 5 | 96 | 0 | 99 | 2 | 0 | 101 | 0 | 0 | 100 | 1 |
| Danirixin 25 mg | 101 | 0 | 98 | 3 | 0 | 101 | 0 | 0 | 101 | 0 | 0 | 101 | 0 | 3 | 97 | 1 | 0 | 101 | 0 | 0 | 101 | 0 | 0 | 101 | 0 | 8 | 92 | 1 | 101 | 0 | 1 | 100 | 0 | 0 | 101 | 0 |
| Danirixin 35 mg | 101 | 0 | 100 | 1 | 0 | 102 | 0 | 0 | 102 | 0 | 0 | 102 | 0 | 2 | 99 | 1 | 0 | 102 | 0 | 2 | 100 | 0 | 0 | 102 | 0 | 7 | 93 | 1 | 100 | 1 | 3 | 98 | 0 | 0 | 99 | 2 |
| Danirixin 5 mg | 102 | 0 | 101 | 1 | 0 | 102 | 0 | 0 | 102 | 0 | 0 | 102 | 0 | 1 | 99 | 2 | 0 | 102 | 0 | 1 | 101 | 0 | 0 | 102 | 0 | 7 | 95 | 0 | 101 | 1 | 0 | 102 | 0 | 1 | 99 | 2 |
| Danirixin 50 mg | 99 | 0 | 98 | 1 | 0 | 99 | 0 | 1 | 98 | 0 | 0 | 99 | 0 | 2 | 97 | 0 | 0 | 99 | 0 | 0 | 99 | 0 | 1 | 98 | 0 | 4 | 94 | 1 | 98 | 1 | 1 | 98 | 0 | 0 | 99 | 0 |
| Placebo | 97 | 0 | 97 | 0 | 0 | 97 | 0 | 0 | 97 | 0 | 0 | 97 | 0 | 2 | 93 | 2 | 0 | 97 | 0 | 1 | 96 | 0 | 0 | 97 | 0 | 3 | 94 | 0 | 97 | 0 | 0 | 97 | 0 | 0 | 97 | 0 |
Triplicate 12-lead ECG obtained to measure PR, QRS, QT, and Corrected QT intervals. Only those participants with worst case post-Baseline data have been represented for abnormal - not clinical significant and abnormal - clinical significant. Day 1 was considered as Baseline. (NCT03034967)
Timeframe: Baseline and Day 168
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Not Clinical significant | Clinical significant | |
| Danirixin 10 mg | 68 | 1 |
| Danirixin 25 mg | 67 | 0 |
| Danirixin 35 mg | 62 | 3 |
| Danirixin 5 mg | 65 | 1 |
| Danirixin 50 mg | 53 | 1 |
| Placebo | 52 | 2 |
Vital signs parameters includes systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate and respiration rate were measured in a semi-supine position after 5 minutes rest for the participants at indicated time points. PCI ranges for vital signs parameters were as follows: <90 to >160 millimeters of mercury (mmHg) for SBP and <40 to >110 mmHg for DBP, <35 or >120 beats per minute for heart rate and <8 or >30 breaths per minute for respiration rate. Values above and below this range were considered of PCI. (NCT03034967)
Timeframe: Up to Day 168
| Intervention | Participants (Count of Participants) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SBP, Low | SBP, No change | SBP, High | DBP, Low | DBP, No change | DBP, High | Pulse rate, Low | Pulse rate, No change | Pulse rate, High | Respiratory rate, Low | Respiratory rate, No change | Respiratory rate, High | |
| Danirixin 10 mg | 0 | 95 | 6 | 0 | 101 | 0 | 0 | 99 | 2 | 0 | 101 | 0 |
| Danirixin 25 mg | 0 | 98 | 3 | 0 | 101 | 0 | 0 | 100 | 1 | 0 | 101 | 0 |
| Danirixin 35 mg | 0 | 98 | 4 | 0 | 102 | 0 | 0 | 102 | 0 | 0 | 102 | 0 |
| Danirixin 5 mg | 0 | 92 | 10 | 0 | 102 | 0 | 0 | 102 | 0 | 0 | 102 | 0 |
| Danirixin 50 mg | 1 | 94 | 4 | 0 | 99 | 0 | 0 | 98 | 1 | 0 | 98 | 1 |
| Placebo | 0 | 93 | 3 | 0 | 96 | 0 | 0 | 96 | 0 | 0 | 96 | 0 |
A participant was consider Responder according to SGRQ total score if their change from Baseline SGRQ total score of 4 units below Baseline or lower. (NCT03034967)
Timeframe: Day 84 and Day 168
| Intervention | Participants (Number) | |
|---|---|---|
| Day 84, n=93, 97, 94, 96, 91, 90 | Day 168, n=85, 96, 86, 90, 86, 85 | |
| Danirixin 10 mg | 35 | 40 |
| Danirixin 25 mg | 49 | 47 |
| Danirixin 35 mg | 35 | 41 |
| Danirixin 5 mg | 40 | 47 |
| Danirixin 50 mg | 38 | 34 |
| Placebo | 39 | 35 |
The Clinical Visit PROactive Physical Activity in COPD (C-PPAC) tool is a designed for intermittent use within a clinical study. PROactive Total Score and two domain scores (amount and difficulty) are derived using data from the C-PPAC questionnaire and a physical activity monitor worn for 7 days prior to the questionnaire.C-PPAC is a 12 item questionnaire. The PROactive tools are scored from 0 to 100 with higher scores indicating greater disease impact. It was implemented in a subset of approximately 50% of participants. The amount domain is calculated using 2 items from the C-PPAC questionnaire (amount of walking outside and chores outside) and 2 activity monitor outputs (vector magnitude units per minute (VMU/min) and steps/day). Each domain score is based on the addition of items (0-15 for amount and 0-40 for difficulty) and then scaled from 0-100. The total score is calculated as (amount+difficulty)/2. (NCT03034967)
Timeframe: Days 84 and 168
| Intervention | Scores on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Total score, Day 84, n=8, 4, 6, 6, 10, 6 | Total score, Day 168, n=13, 7, 9, 8, 6, 7 | Amount score, Day 84, n=8, 4, 6, 6, 10, 6 | Amount score, Day 168, n=13, 7, 9, 8, 6, 7 | Difficult score, Day 84, n=29, 22, 18, 19, 24, 14 | Difficult score, Day 168, n=29, 20, 18, 19, 25, 15 | |
| Danirixin 10 mg | -3.83 | 2.11 | -4.00 | 2.11 | -0.17 | 2.11 |
| Danirixin 25 mg | 0.42 | 1.25 | 0.00 | 1.25 | 1.89 | 0.63 |
| Danirixin 35 mg | -1.20 | 4.08 | -4.20 | 3.67 | 2.79 | 1.52 |
| Danirixin 5 mg | -5.75 | 1.86 | -8.50 | -0.43 | 1.64 | 2.20 |
| Danirixin 50 mg | 2.33 | 0.43 | -0.83 | -4.14 | 4.50 | 4.87 |
| Placebo | 3.00 | -0.96 | 2.25 | -3.69 | 6.38 | 3.03 |
The time to first on-treatment EXACT event was calculated as the onset date of the first on-treatment EXACT event minus date of start of treatment plus 1. (NCT03034967)
Timeframe: Up to Day 168
| Intervention | Days (Number) | |
|---|---|---|
| First quartile (Q1) time to event | Median time to event | |
| Danirixin 10 mg | NA | NA |
| Danirixin 25 mg | NA | NA |
| Danirixin 35 mg | NA | NA |
| Danirixin 5 mg | NA | NA |
| Danirixin 50 mg | NA | NA |
| Placebo | NA | NA |
The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1. (NCT03034967)
Timeframe: Up to Day 196
| Intervention | Days (Number) | |
|---|---|---|
| Q1 time to event | Median time to event | |
| Danirixin 10 mg | 63 | NA |
| Danirixin 25 mg | 79 | NA |
| Danirixin 35 mg | 70 | NA |
| Danirixin 5 mg | 47 | NA |
| Danirixin 50 mg | 57 | 152 |
| Placebo | 110 | NA |
A COPD exacerbation defined as a severe exacerbation if it requires hospitalization or ER visit or extended observation. The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1. (NCT03034967)
Timeframe: Up to Day 196
| Intervention | Days (Number) | |
|---|---|---|
| Q1 time to event | Median time to event | |
| Danirixin 10 mg | NA | NA |
| Danirixin 25 mg | NA | NA |
| Danirixin 35 mg | NA | NA |
| Danirixin 5 mg | NA | NA |
| Danirixin 50 mg | NA | NA |
| Placebo | NA | NA |
Blood samples were collected from the participants for the analysis of pharmacokinetic parameter. (NCT03034967)
Timeframe: Days 1 and 168
| Intervention | Hours (Median) | |
|---|---|---|
| Day 1, n=17, 19, 24, 26, 19 | Day 168, n=14, 13, 17, 18, 16 | |
| Danirixin 10 mg | 1.000 | 1.000 |
| Danirixin 25 mg | 1.000 | 1.000 |
| Danirixin 35 mg | 1.000 | 1.000 |
| Danirixin 5 mg | 1.000 | 1.000 |
| Danirixin 50 mg | 1.000 | 1.542 |
The absorptive clearance rate is the percentage of the radiolabeled small molecule DTPA that is cleared through absorption over a 60 minute period. Total DTPA clearance includes absorptive and mucociliary components. The mucociliary component is determined by measuring the clearance of a radiolabeled particle over the same period (Technetium 99m sulfur colloid; Tc-SC), and subtracted from total DTPA clearance in order to determine the absorptive component. Here we specifically report absorption from the central lung zone to capture the behavior within the airways. (NCT00541190)
Timeframe: single measurement
| Intervention | percentage of DTPA absoprtion per hour (Mean) |
|---|---|
| Cystic Fibrosis | 42 |
| Healthy Controls | 32 |
"Mucociliary clearance rate represents the rate at which the lungs clear an inhaled particulate. Here it specifically represents the percentage of inhaled Technetium 99m sulfur colloid cleared from the lungs over a 60 minute period. This is reported based on whole lung areas to allow comparisons with previous studies." (NCT00541190)
Timeframe: single measurement
| Intervention | percentage lung clearance per hour (Mean) |
|---|---|
| Cystic Fibrosis | 8 |
| Healthy Controls | 7 |
The absorption rate of In-DTPA after the inhalation of hypertonic saline (NCT01223183)
Timeframe: 80 minutes after radiopharmaceutical inhalation
| Intervention | percent cleared / 80 minutes (Mean) |
|---|---|
| Hypertonic Saline Inhalation | 22.2 |
The absorption rate of Indium 111 diethylenetriaminepentaacetic acid (In-DTPA) in the airways after the inhalation of isotonic saline (NCT01223183)
Timeframe: 80 minutes after radiopharmaceutical inhalation
| Intervention | percent cleared / 80 minutes (Mean) |
|---|---|
| Isotonic Saline Inhalation | 32.0 |
The clearance rate of Tc-SC after the inhalation of hypertonic saline (NCT01223183)
Timeframe: 80 minutes after radiopharmaceutical inhalation
| Intervention | percent cleared / 80 minutes (Mean) |
|---|---|
| Hypertonic Saline Inhalation | 42.4 |
The clearance rate of Tc-SC after the inhalation of isotonic saline (NCT01223183)
Timeframe: 80 minutes after radiopharmaceutical inhalation
| Intervention | percent cleared / 80 minutes (Mean) |
|---|---|
| Isotonic Saline Inhalation | 23.6 |
Absorptive Clearance Rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of In-DTPA from the lungs. (NCT01486199)
Timeframe: t=2 years
| Intervention | percent cleared / 80 min (Mean) |
|---|---|
| CF Pediatric | 28.6 |
Absorptive clearance rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of Indium 111-diethylenetriaminepentaacetic acid (In-DTPA) from the lungs. (NCT01486199)
Timeframe: study day 1
| Intervention | percent cleared / 80 minutes (Mean) |
|---|---|
| CF Pediatric | 34.0 |
| Controls Adult | 17.7 |
Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs. (NCT01486199)
Timeframe: study day 1
| Intervention | percent cleared / 80 minutes (Mean) |
|---|---|
| CF Pediatric | 22.8 |
| Controls Adult | 31.4 |
Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs. (NCT01486199)
Timeframe: t=2 years, measure made 80 minutes after radiopharmaceutical inhalation
| Intervention | percent cleared / 80 minutes (Mean) |
|---|---|
| CF Pediatric | 22.0 |
14 reviews available for guaifenesin and Disease Exacerbation
| Article | Year |
|---|---|
The role of mucosal barriers in disease progression and transmission.
Topics: Communicable Diseases; Disease Progression; Humans; Mucins; Mucous Membrane; Mucus | 2023 |
Oscillating devices for airway clearance in people with cystic fibrosis.
Topics: Adolescent; Adult; Breathing Exercises; Chest Wall Oscillation; Child; Cystic Fibrosis; Disease Prog | 2020 |
Oscillating devices for airway clearance in people with cystic fibrosis.
Topics: Adolescent; Adult; Breathing Exercises; Chest Wall Oscillation; Child; Cystic Fibrosis; Disease Prog | 2020 |
Oscillating devices for airway clearance in people with cystic fibrosis.
Topics: Adolescent; Adult; Breathing Exercises; Chest Wall Oscillation; Child; Cystic Fibrosis; Disease Prog | 2020 |
Oscillating devices for airway clearance in people with cystic fibrosis.
Topics: Adolescent; Adult; Breathing Exercises; Chest Wall Oscillation; Child; Cystic Fibrosis; Disease Prog | 2020 |
Mucoactive and antioxidant medicines for COPD: consensus of a group of Chinese pulmonary physicians.
Topics: Antioxidants; China; Consensus; Disease Progression; Expectorants; Humans; Lung; Mucociliary Clearan | 2017 |
Oscillating devices for airway clearance in people with cystic fibrosis.
Topics: Adolescent; Adult; Breathing Exercises; Chest Wall Oscillation; Child; Cystic Fibrosis; Disease Prog | 2017 |
The pathology of small airways disease in COPD: historical aspects and future directions.
Topics: Airway Remodeling; Animals; Disease Progression; Forecasting; Humans; Inflammation; Lung; Mucus; Pul | 2019 |
Muco-Obstructive Lung Diseases.
Topics: Bronchiectasis; Cilia; Cystic Fibrosis; Disease Progression; Expectorants; Humans; Lung Diseases, Ob | 2019 |
The role of macrolides in asthma: current evidence and future directions.
Topics: Anti-Infective Agents; Asthma; Disease Progression; Humans; Immunomodulation; Macrolides; Mucus; Phe | 2014 |
Standard (head-down tilt) versus modified (without head-down tilt) postural drainage in infants and young children with cystic fibrosis.
Topics: Anti-Bacterial Agents; Child, Preschool; Cystic Fibrosis; Disease Progression; Drainage, Postural; G | 2015 |
Mucus, phlegm, and sputum in cystic fibrosis.
Topics: Cystic Fibrosis; Disease Progression; Expectorants; Humans; Mucus; Respiratory Mucosa; Sputum | 2009 |
Pathobiologic mechanisms of chronic obstructive pulmonary disease.
Topics: Adaptive Immunity; Airway Remodeling; Biomarkers; Cytochrome P-450 Enzyme System; Disease Progressio | 2012 |
Chronic bronchitis and chronic obstructive pulmonary disease.
Topics: Adrenergic beta-Agonists; Anti-Bacterial Agents; Antioxidants; Bronchitis, Chronic; Cholinergic Anta | 2013 |
Classification of severe asthma exacerbations: a proposal.
Topics: Administration, Inhalation; Administration, Oral; Allergens; Anti-Inflammatory Agents, Non-Steroidal | 1996 |
Allergic bronchopulmonary aspergillosis.
Topics: Administration, Oral; Aspergillosis, Allergic Bronchopulmonary; Aspergillus fumigatus; Asthma; Bronc | 1999 |
Bacterial infection and the pathogenesis of COPD.
Topics: Bacteria; Disease Progression; Humans; Immunity, Cellular; Lung Diseases, Obstructive; Mucociliary C | 2000 |
2 trials available for guaifenesin and Disease Exacerbation
42 other studies available for guaifenesin and Disease Exacerbation
| Article | Year |
|---|---|
Effect of Benralizumab on Mucus Plugs in Severe Eosinophilic Asthma.
Topics: Anti-Asthmatic Agents; Asthma; Disease Progression; Eosinophils; Humans; Mucus; Pulmonary Eosinophil | 2023 |
Escalation in mucus cystatin 2, pappalysin-A, and periostin levels over time predict need for recurrent surgery in chronic rhinosinusitis with nasal polyps.
Topics: Adult; Cell Adhesion Molecules; Chronic Disease; Disease Progression; Female; Humans; Male; Middle A | 2019 |
[Mucus buildup: the starting point of cystic fibrosis lung disease pathogenesis].
Topics: Bronchiectasis; Child; Child, Preschool; Cilia; Cystic Fibrosis; Cystic Fibrosis Transmembrane Condu | 2019 |
Mucus plugging, air trapping, and bronchiectasis are important outcome measures in assessing progressive childhood cystic fibrosis lung disease.
Topics: Adolescent; Bronchi; Bronchiectasis; Child; Cystic Fibrosis; Disease Progression; Female; Forced Exp | 2020 |
Procedures to Evaluate Inflammatory and Pathological Changes During Allergic Airway Inflammation.
Topics: Allergens; Animals; Asthma; Bronchoalveolar Lavage Fluid; Cytokines; Disease Progression; Lung; Mice | 2021 |
Charcot-Leyden Crystals in Rapidly Progressing Plastic Bronchitis.
Topics: Biomarkers; Bronchi; Bronchitis; Child, Preschool; Crystallization; Disease Progression; Eosinophils | 2021 |
Lung macrophages drive mucus production and steroid-resistant inflammation in chronic bronchitis.
Topics: Aged; Biomarkers; Bronchitis, Chronic; Disease Progression; Drug Resistance; Female; Follow-Up Studi | 2021 |
Progression of Type 2 Helper T Cell-Type Inflammation and Airway Remodeling in a Rodent Model of Naturally Acquired Subclinical Primary Pneumocystis Infection.
Topics: Animals; Bronchioles; Disease Models, Animal; Disease Progression; Extracellular Matrix; Female; Gen | 2018 |
Mucus hypersecretion in asthma is associated with rhinosinusitis, polyps and exacerbations.
Topics: Adult; Aged; Asthma; Cough; Disease Progression; Female; Humans; Male; Middle Aged; Mucus; Olfaction | 2018 |
The Food Additive Maltodextrin Promotes Endoplasmic Reticulum Stress-Driven Mucus Depletion and Exacerbates Intestinal Inflammation.
Topics: Animals; Cattle; Colitis; Diet; Disease Progression; Endoplasmic Reticulum Stress; Epithelial Cells; | 2019 |
Frontline Science: Abnormalities in the gut mucosa of non-obese diabetic mice precede the onset of type 1 diabetes.
Topics: Animals; Cytokines; Dendritic Cells; Diabetes Mellitus, Type 1; Disease Progression; Dysbiosis; Fema | 2019 |
Discriminant analysis followed by unsupervised cluster analysis including exosomal cystatins predict presence of chronic rhinosinusitis, phenotype, and disease severity.
Topics: Adult; Aged; Chronic Disease; Cluster Analysis; Discriminant Analysis; Disease Progression; Exosomes | 2019 |
Exacerbated airway toxicity of environmental oxidant ozone in mice deficient in Nrf2.
Topics: Animals; Antioxidants; Bronchoalveolar Lavage Fluid; Disease Progression; Environmental Exposure; Lu | 2013 |
Non invasive assessment of lung disease in ataxia telangiectasia by high-field magnetic resonance imaging.
Topics: Adolescent; Adult; Ataxia Telangiectasia; Bronchiectasis; Child; Disease Progression; Feasibility St | 2013 |
Tumor necrosis factor-related apoptosis-inducing ligand translates neonatal respiratory infection into chronic lung disease.
Topics: Animals; Animals, Newborn; Antibodies, Neutralizing; Apoptosis; Chlamydia Infections; Chlamydia muri | 2014 |
The human cathelicidin LL-37 enhances airway mucus production in chronic obstructive pulmonary disease.
Topics: Aged; Antimicrobial Cationic Peptides; Cathelicidins; Cells, Cultured; Disease Progression; ErbB Rec | 2014 |
A biophysical basis for mucus solids concentration as a candidate biomarker for airways disease.
Topics: Adult; Aged; Biomarkers; Cystic Fibrosis; Diffusion; Disease Progression; Elasticity; Fourier Analys | 2014 |
Intelectin-1 is a prominent protein constituent of pathologic mucus associated with eosinophilic airway inflammation in asthma.
Topics: Asthma; Case-Control Studies; Cytokines; Disease Progression; Eosinophils; GPI-Linked Proteins; Huma | 2014 |
The intestinal mucus layer is a critical component of the gut barrier that is damaged during acute pancreatitis.
Topics: Acute Disease; Amylases; Animals; Antioxidants; Disease Models, Animal; Disease Progression; Ileum; | 2014 |
On the Pathogenesis of Acute Exacerbations of Mucoobstructive Lung Diseases.
Topics: Animals; Disease Models, Animal; Disease Progression; Humans; Lung; Lung Diseases, Obstructive; Mice | 2015 |
The Presence of Chronic Mucus Hypersecretion across Adult Life in Relation to Chronic Obstructive Pulmonary Disease Development.
Topics: Adult; Age Factors; Aging; Chronic Disease; Disease Progression; Female; Humans; Lung; Male; Middle | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Pseudomonas infection and mucociliary and absorptive clearance in the cystic fibrosis lung.
Topics: Administration, Inhalation; Adult; Aerosols; Cystic Fibrosis; Disease Progression; Female; Humans; L | 2016 |
Early-Life Intranasal Colonization with Nontypeable Haemophilus influenzae Exacerbates Juvenile Airway Disease in Mice.
Topics: Animals; Bacterial Load; Cytokines; Disease Models, Animal; Disease Progression; Female; Haemophilus | 2016 |
The involvement of central nervous system histamine receptors in psychological stress-induced exacerbation of allergic airway inflammation in mice.
Topics: Animals; Antigens; Bronchial Hyperreactivity; Bronchoalveolar Lavage Fluid; Central Nervous System; | 2016 |
IκBNS induces Muc5ac expression in epithelial cells and causes airway hyper-responsiveness in murine asthma models.
Topics: Allergens; Animals; Asthma; Blood Cells; Cytokines; Dermatophagoides pteronyssinus; Disease Models, | 2017 |
Gastric mucus alterations associated with murine Helicobacter infection.
Topics: Adenocarcinoma; Animals; Chronic Disease; Disease Progression; Female; Gastric Mucins; Gastric Mucos | 2009 |
Cyclin D1 negatively regulates the expression of differentiation genes in HT-29 M6 mucus-secreting colon cancer cells.
Topics: Blotting, Western; Cell Cycle; Cell Dedifferentiation; Cell Differentiation; Cell Line, Tumor; Cell | 2009 |
Mucoid and nonmucoid Burkholderia cepacia complex bacteria in cystic fibrosis infections.
Topics: Adolescent; Adult; Burkholderia cepacia complex; Burkholderia Infections; Cystic Fibrosis; Disease P | 2011 |
In vivo monitoring of cystic fibrosis-like lung disease in mice by volumetric computed tomography.
Topics: Airway Obstruction; Animals; Bronchography; Cone-Beam Computed Tomography; Cystic Fibrosis; Disease | 2011 |
Molecular insights into the progression of crystalline silica-induced pulmonary toxicity in rats.
Topics: Acute Lung Injury; Administration, Inhalation; Air Pollutants, Occupational; Animals; Chloride-Bicar | 2013 |
IL-17A and IL-25: therapeutic targets for allergic and exacerbated asthmatic disease.
Topics: Allergens; Asthma; Disease Progression; Humans; Hypersensitivity; Interleukin-17; Lung; Molecular Ta | 2012 |
Mucus distribution model in a lung with cystic fibrosis.
Topics: Adolescent; Adult; Aged; Algorithms; Biofilms; Computer Simulation; Cystic Fibrosis; Disease Progres | 2012 |
[Study on the correlation between positive rates of SARS RNA in clinical confirmed SARS patients and the appearance of RNA in relation to the development of the disease].
Topics: Adolescent; Adult; Aged; Chi-Square Distribution; China; Disease Progression; Feces; Female; Humans; | 2004 |
Therapeutic dosing with anti-interleukin-13 monoclonal antibody inhibits asthma progression in mice.
Topics: Animals; Antibodies, Monoclonal; Asthma; Bronchial Hyperreactivity; Bronchoalveolar Lavage Fluid; Ch | 2005 |
Plaunotol prevents the progression of acute gastric mucosal lesions induced by compound 48/80, a mast cell degranulator, in rats.
Topics: Animals; Anti-Ulcer Agents; Ascorbic Acid; Blood Flow Velocity; Cell Degranulation; Disease Progress | 2005 |
A comparison of airway and serum matrix metalloproteinase-9 activity among normal subjects, asthmatic patients, and patients with asthmatic mucus hypersecretion.
Topics: Analysis of Variance; Asthma; Biomarkers; Bronchoalveolar Lavage Fluid; Bronchoscopy; Case-Control S | 2005 |
Plasma cells and IL-4 in chronic bronchitis and chronic obstructive pulmonary disease.
Topics: Aged; Aged, 80 and over; Biomarkers; Bronchi; Bronchitis, Chronic; Disease Progression; Fluorescent | 2007 |
Survival after lung volume reduction in chronic obstructive pulmonary disease: insights from small airway pathology.
Topics: Adrenal Cortex Hormones; Cross-Sectional Studies; Disease Progression; Female; Forced Expiratory Vol | 2007 |
Airway inflammation in COPD: friend or foe?
Topics: Anti-Inflammatory Agents; Disease Progression; Humans; Immunity; Inflammation; Mucus; Pulmonary Dise | 2007 |
Lower respiratory tract disease in Thoroughbred racehorses: analysis of endoscopic data from a UK training yard.
Topics: Age Factors; Animals; Anti-Bacterial Agents; Disease Progression; Endoscopy; Female; Horse Diseases; | 2008 |
The chemotactic activity of sputum from patients with bronchiectasis.
Topics: Acute Disease; Anti-Bacterial Agents; Antibodies, Monoclonal; Benzoates; Bronchiectasis; Bronchitis; | 1998 |
Oral and ocular manifestations in Sjögren's syndrome.
Topics: Adult; Aged; Aged, 80 and over; Antibodies, Antinuclear; Disease Progression; Dry Eye Syndromes; Fem | 2002 |