mometasone-furoate and Chronic-Disease

Asthma is characterised by chronic inflammation of the airways and recurrent exacerbations with wheezing, chest tightness, and cough. Treatment with inhaled steroids and bronchodilators can result in good control of symptoms, prevention of further morbidity, and improved quality of life. However, an increase in serious adverse events with the use of both regular formoterol and regular salmeterol (long-acting beta₂-agonists) compared with placebo for chronic asthma has been demonstrated in previous Cochrane Reviews. This increase was statistically significant in trials that did not randomise participants to an inhaled corticosteroid, but not when formoterol or salmeterol was combined with an inhaled corticosteroid. The confidence intervals were found to be too wide to ensure that the addition of an inhaled corticosteroid renders regular long-acting beta₂-agonists completely safe; few participants and insufficient serious adverse events in these trials precluded a definitive decision about the safety of combination treatments.. To assess risks of mortality and non-fatal serious adverse events in trials that have randomised patients with chronic asthma to regular formoterol and an inhaled corticosteroid versus regular salmeterol and an inhaled corticosteroid.. We searched the Cochrane Airways Register of Trials, CENTRAL, MEDLINE, Embase, and two trial registries to identify reports of randomised trials for inclusion. We checked manufacturers' websites and clinical trial registers for unpublished trial data, as well as Food and Drug Administration (FDA) submissions in relation to formoterol and salmeterol. The date of the most recent search was  24 February 2021.. We included controlled clinical trials with a parallel design, recruiting patients of any age and severity of asthma, if they randomised patients to treatment with regular formoterol versus regular salmeterol (each with a randomised inhaled corticosteroid) and were of at least 12 weeks' duration.. Two review authors independently selected trials for inclusion in the review, extracted outcome data from published papers and trial registries, and applied GRADE rating for the results. We sought unpublished data on mortality and serious adverse events from study sponsors and authors. The primary outcomes were all cause mortality and non-fatal serious adverse events. We chose not to calculate an average result from all the formulations of formoterol and inhaled steroid, as the doses and delivery devices are too diverse to assume a single class effect.. Twenty-one studies in 11,572 adults and adolescents and two studies in 723 children met the eligibility criteria of the review. No data were available for two studies; therefore these were not included in the analysis. Among adult and adolescent studies, seven compared formoterol and budesonide to salmeterol and fluticasone (N = 7764), six compared formoterol and beclomethasone to salmeterol and fluticasone (N = 1923), two compared formoterol and mometasone to salmeterol and fluticasone (N = 1126), two compared formoterol and fluticasone to salmeterol and fluticasone (N = 790), and one compared formoterol and budesonide to salmeterol and budesonide (N = 229). In total, five deaths were reported among adults, none of which was thought to be related to asthma. The certainty of evidence for all-cause mortality was low, as there were not enough deaths to permit any precise conclusions regarding the risk of mortality on combination formoterol versus combination salmeterol. In all, 201 adults reported non-fatal serious adverse events. In studies comparing formoterol and budesonide to salmeterol and fluticasone, there were 77 in the formoterol arm and 68 in the salmeterol arm (Peto odds ratio (OR) 1.14, 95% confidence interval (CI) 0.82 to 1.59; 5935 participants, 7 studies; moderate-certainty evidence). In the formoterol and beclomethasone studies, there were 12 adults in the formoterol arm and 13 in the salmeterol arm with events (Peto OR 0.94, 95% CI 0.43 to 2.08; 1941 participants, 6 studies; moderate-certainty evidence). In the formoterol and mometasone studies, there were 18 in the formoterol arm and 11 in the salmeterol arm (Peto OR 1.02, 95% CI 0.47 to 2.20; 1126 participants, 2 studies; moderate-certainty evidence). One adult in the formoterol and fluticasone studies in the salmeterol arm experienced an event (Peto OR 0.05, 95% CI 0.00 to 3.10; 293 participants, 2 studies; low-certainty evidence). Another adult in the formoterol and budesonide compared to salmeterol and budesonide study in the formoterol arm had an event (Peto OR 7.45, 95% CI 0.15 to 375.68; 229 participants, 1 study; low-certainty evidence). Only 46 adults were reported to have experienced asthma-related serious adverse events. The certainty of the evidence was low to very low due to the small number of events and the absence of independent assessment of causation. The two studies in children compared formoterol and fluticasone to salmeterol and fluticasone. No deaths and no asthma-rel. Overall, for both adults and children, evidence is insufficient to show whether regular formoterol in combination with budesonide, beclomethasone, fluticasone, or mometasone has a different safety profile from salmeterol in combination with fluticasone or budesonide. Five deaths of any cause were reported across all studies and no deaths from asthma; this information is insufficient to permit any firm conclusions about the relative risks of mortality on combination formoterol in comparison to combination salmeterol inhalers. Evidence on all-cause non-fatal serious adverse events indicates that there is probably little to no difference between formoterol/budesonide and salmeterol/fluticasone inhalers. However events for the other formoterol combination inhalers were too few to allow conclusions. Only 46 non-fatal serious adverse events were thought to be asthma related; this small number in addition to the absence of independent outcome assessment means that we have very low confidence for this outcome. We found no evidence of safety issues that would affect the choice between salmeterol and formoterol combination inhalers used for regular maintenance therapy by adults and children with asthma.

Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Beclomethasone; Bronchodilator Agents; Budesonide; Child; Chronic Disease; Drug Therapy, Combination; Fluticasone; Formoterol Fumarate; Glucocorticoids; Humans; Mometasone Furoate; Randomized Controlled Trials as Topic; Salmeterol Xinafoate

Asthma guidelines provide clinicians with evidence-based management strategies for this chronic condition. The preferred therapy for patient with persistent asthma is inhaled corticosteroids. However, ∼40% of the patients with persistent asthma continue to present with symptoms while treated according to the guidelines. Multiple factors are being explored to explain the variability in response to inhaled corticosteroids including asthma phenotype and genetic predisposition among others. The nonatopic asthma phenotype has been described in the literature. These patients tend to have milder symptoms of asthma and typically outgrow their asthma by adolescence. They present with chronic asthma symptoms in the absence of a positive allergy test, either skin prick test or specific immunoglobulin E blood test. Although patients with nonatopic asthma share many characteristics with patients with atopic asthma, there are several studies that suggest a different inflammatory pathway may be involved in their pathophysiology. Therefore, it is possible that children with nonatopic asthma could respond differently to inhaled corticosteroids compared with those with atopic asthma. Currently there is a variable definition of this phenotype. Furthermore, there is a paucity of therapeutic trial directed toward the patients with nonatopic asthma specifically. Future research should be guided toward identifying the inflammatory pathways in nonatopic asthma and potential phenotype-guided therapies.

Topics: Allergy and Immunology; Anti-Asthmatic Agents; Asthma; Bronchi; Child; Chronic Disease; Diagnosis, Differential; Gastroesophageal Reflux; Humans; Mometasone Furoate; Practice Guidelines as Topic; Proton Pump Inhibitors; Respiratory Mucosa; Respiratory Sounds; Tiotropium Bromide; Treatment Outcome

Topics: Anti-Inflammatory Agents; Chronic Disease; Drug Implants; Endoscopy; Humans; Mometasone Furoate; Nasal Polyps; Paranasal Sinuses; Recurrence; Rhinitis; Sinusitis

This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Topical (intranasal) corticosteroids are used with the aim of reducing inflammation in the sinonasal mucosa in order to improve patient symptoms.. To assess the effects of different types of intranasal steroids in people with chronic rhinosinusitis.. The Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 7); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 11 August 2015.. Randomised controlled trials (RCTs) with a follow-up period of at least three months comparing first-generation intranasal corticosteroids (e.g. beclomethasone dipropionate, triamcinolone acetonide, flunisolide, budesonide) with second-generation intranasal corticosteroids (e.g. ciclesonide, fluticasone furoate, fluticasone propionate, mometasone furoate, betamethasone sodium phosphate), or sprays versus drops, or low-dose versus high-dose intranasal corticosteroids.. We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis (nosebleed). Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse event of local irritation. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.. We included nine RCTs (911 participants), including four different comparisons. None of the studies evaluated our first primary outcome measure, disease-specific HRQL. Fluticasone propionate versus beclomethasone dipropionate We identified two small studies (56 participants with polyps) that evaluated disease severity and looked at the primary adverse effect: epistaxis , but no other outcomes. We cannot report any numerical data but the study authors reported no difference between the two steroids. The evidence was of very low quality. Fluticasone propionate versus mometasone furoate We identified only one study (100 participants with polyps) that evaluated disease severity (nasal symptoms scores), which reported no difference (no numerical data available). The evidence was of very low quality. High-dose versus low-dose steroidsWe included five studies (663 participants with nasal polyps), three using mometasone furoate (400 µg versus 200 µg in adults and older children, 200 µg versus 100 µg in younger children) and two using fluticasone propionate drops (800 µg versus 400 µg). We found low quality evidence relating to disease severity and nasal polyps size, with results from the high-dose and low-dose groups being similar. Although all studies reported more improvement in polyp score in the high-dose group, the significance of this is unclear due to the small size of the improvements.The primary adverse effect, epistaxis , was more common when higher doses were used (risk ratio (RR) 2.06, 95% confidence interval (CI) 1.20 to 3.54, 637 participants, moderate quality evidence). Most of the studies that contributed data to this outcome used a broad definition of epistaxis, which ranged from frank bleeding to bloody nasal discharge to flecks of blood in the mucus. Aqueous nasal spray versus aerosol spray We identified only one poorly reported study (unclear number of participants for comparison of interest, 91 between three treatment arms), in which there were significant baseline differences between the participants in the two groups. We were unable to draw meaningful conclusions from the data.. We found insufficient evidence to suggest that one type of intranasal steroid is more effective than another in patients with chronic rhinosinusitis, nor that the effectiveness of a spray differs from an aerosol. We identified no studies that compared drops with spray.It is unclear if higher doses result in better symptom improvements (low quality evidence), but there was moderate quality evidence of an increased risk of epistaxis as an adverse effect of treatment when higher doses were used. This included all levels of severity of epistaxis and it is likely that the proportion of events that required patients to discontinue usage is low due to the low numbers of withdrawals attributed to it. If epistaxis is limited to streaks of blood in the mucus it may be tolerated by the patient and it may be safe to continue treatment. However, it may be a factor that affects compliance.There is insufficient evidence to suggest that the different types of corticosteroid molecule or spray versus aerosol have different effects. Lower doses have similar effectiveness but fewer side effects.Clearly more research in this area is needed, with specific attention given to trial design, disease-specific health-related quality of life outcomes and evaluation of longer-term outcomes and adverse effects.

Topics: Administration, Intranasal; Adult; Beclomethasone; Child; Chronic Disease; Fluticasone; Humans; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Steroids

This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. The use of topical (intranasal) corticosteroids has been widely advocated for the treatment of chronic rhinosinusitis given the belief that inflammation is a major component of this condition.. To assess the effects of intranasal corticosteroids in people with chronic rhinosinusitis.. The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 8); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 11 August 2015.. Randomised controlled trials (RCTs) with a follow-up period of at least three months comparing intranasal corticosteroids (e.g. beclomethasone dipropionate, triamcinolone acetonide, flunisolide, budesonide) against placebo or no treatment in patients with chronic rhinosinusitis.. We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse events of local irritation or other systemic adverse events. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.. We included 18 RCTs with a total of 2738 participants. Fourteen studies had participants with nasal polyps and four studies had participants without nasal polyps. Only one study was conducted in children. Intranasal corticosteroids versus placebo or no intervention Only one study (20 adult participants without polyps) measured our primary outcome disease-specific HRQL using the Rhinosinusitis Outcome Measures-31 (RSOM-31). They reported no significant difference (numerical data not available) (very low quality evidence).Our second primary outcome, disease severity , was measured using the Chronic Sinusitis Survey in a second study (134 participants without polyps), which found no important difference (mean difference (MD) 2.84, 95% confidence interval (CI) -5.02 to 10.70; scale 0 to 100). Another study (chronic rhinosinusitis with nasal polyps) reported an increased chance of improvement in the intranasal corticosteroids group (RR 2.78, 95% CI 1.76 to 4.40; 109 participants). The quality of the evidence was low.Six studies provided data on at least two of the individual symptoms used in the EPOS 2012 criteria to define chronic rhinosinusitis (nasal blockage, rhinorrhoea, loss of sense of smell and facial pain/pressure). When all four symptoms in the EPOS criteria were available on a scale of 0 to 3 (higher = more severe symptoms), the average MD in change from baseline was -0.26 (95% CI -0.37 to -0.15; 243 participants; two studies; low quality evidence). Although there were more studies and participants when only nasal blockage and rhinorrhoea were considered (MD -0.31, 95% CI -0.38 to -0.24; 1702 participants; six studies), the MD was almost identical to when loss of sense of smell was also considered (1345 participants, four studies; moderate quality evidence).When considering the results for the individual symptoms, benefit was shown in the intranasal corticosteroids group. The effect size was larger for nasal blockage (MD -0.40, 95% CI -0.52 to -0.29; 1702 participants; six studies) than for rhinorrhoea (MD -0.25, 95% CI -0.33 to -0.17; 1702 participants; six studies) or loss of sense of smell (MD -0.19, 95% CI -0.28 to -0.11; 1345 participants; four studies). There was heterogeneity in the analysis for facial pain/pressure (MD -0.27, 95% CI -0.56 to 0.02; 243 participants; two studies). The quality of the evidence was moderate for nasal blockage, rhinorrhoea and loss of sense of smell, but low for facial pain/pressure.There was an increased risk of. Most of the evidence available was from studies in patients with chronic rhinosinusitis with nasal polyps. There is little information about quality of life (very low quality evidence). For disease severity, there seems to be improvement for all symptoms (low quality evidence), a moderate-sized benefit for nasal blockage and a small benefit for rhinorrhoea (moderate quality evidence). The risk of epistaxis is increased (high quality evidence), but these data included all levels of severity; small streaks of blood may not be a major concern for patients. It is unclear whether there is a difference in the risk of local irritation (low quality evidence).

Topics: Administration, Intranasal; Adolescent; Adrenal Cortex Hormones; Adult; Beclomethasone; Budesonide; Child; Chronic Disease; Fluticasone; Humans; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Placebos; Quality of Life; Randomized Controlled Trials as Topic; Rhinitis; Severity of Illness Index; Sinusitis; Steroids

Endoscopic sinus surgery (ESS) plays an integral role in the treatment of chronic rhinosinusitis (CRS), with well-documented benefits in both symptoms and quality of life. However, synechiae formation, polypoid change, and mucosal edema can compromise long-term surgical outcomes. Corticosteroids have been found to be effective in managing such postsurgical inflammation, but current delivery methods are limited by poor sinonasal distribution and potential systemic side effects. Sinus implantation offers a novel vehicle for topical drug delivery in CRS; enabling sustained, controlled corticosteroid application directly to sinonasal mucosa.. The bioengineering, mechanism of drug delivery, degradation and resorption of sinus implantation will be delineated. Research findings from animal and clinical studies will be assessed as well as alternative devices. Future directions for this technology in the management of CRS will also be discussed.. The sinus implant is a revolutionary mode of localized drug delivery in CRS. Its utilization enhances wound healing, with diminished need for secondary postoperative medical and surgical interventions. Such novel technology has far-reaching implications, with future indications likely extending beyond the operating room into the clinic setting, to treat CRS patients, with inflammatory exacerbations or recurrent polypoid disease, who would otherwise require additional surgery.

Topics: Animals; Anti-Inflammatory Agents; Chronic Disease; Drug Implants; Endoscopy; Humans; Mometasone Furoate; Postoperative Complications; Pregnadienediols; Rhinitis; Sinusitis

Chronic rhinosinusitis is widely recognized as one of the most common chronic disease entities. Since its introduction in the USA in 1985, the role of functional endoscopic sinus surgery as an adjunct to medical therapy in the treatment of chronic sinus disease has expanded significantly. Corticosteroids are an integral part of the management of the mucosal inflammation in chronic rhinosinusitis, and it is generally accepted that existing routes of delivery to the sinus mucosa are suboptimal. The PROPEL™ steroid-releasing implant (Intersect ENT) initiates a new era in topical therapy providing controlled drug delivery directly to the sinus tissue. The mometasone furoate-releasing implant has been clinically proven to prevent obstruction of the ethmoid sinus following surgery and recently received US FDA approval. Initial studies demonstrate improved postoperative healing with the device, thus reducing the need for additional surgical procedures such as adhesion lysis and systemic steroids.

Topics: Absorbable Implants; Anti-Inflammatory Agents; Chronic Disease; Drug Implants; Endoscopy; Humans; Mometasone Furoate; Pregnadienediols; Rhinitis; Sinusitis

Inhaled mometasone furoate (Asmanex) is a synthetic corticosteroid indicated for the first-line maintenance prophylactic therapy of persistent asthma in adults and adolescents. It is formulated for delivery via a breath-actuated dry powder inhaler (DPI) [Twisthaler].Inhaled mometasone furoate delivered by DPI is effective in treating patients with persistent asthma. It improves pulmonary function and health-related quality of life, reduces symptoms and decreases oral corticosteroid requirements in severe disease. It is a potent anti-inflammatory agent and is at least as clinically effective as other inhaled corticosteroids. Inhaled mometasone furoate is equally effective in controlling asthma when administered in two divided doses or as a single daily dose. Once-daily administration of mometasone furoate 200 microg in the evening was more effective than administration of the same dosage in the morning. The drug is well tolerated, with low systemic bioavailability and minimal systemic activity. Therefore, it is an effective and convenient option for controller therapy of persistent asthma in adults and adolescents.

Topics: Administration, Inhalation; Adolescent; Adult; Anti-Asthmatic Agents; Asthma; Chronic Disease; Humans; Mometasone Furoate; Pregnadienediols; Quality of Life

Eosinophilic chronic rhinosinusitis with nasal polyps (ECRSwNP) is a refractory clinical phenotype with a high symptom burden and relapse rate. Steroid-eluting stents are safe and effective for reducing polyp size, symptom burden, and the need for revision sinus surgery. In this study we aimed to evaluate the efficacy and safety of steroid-eluting stent implantation on the surgical outcomes of patients with ECRSwNP.. This prospective, multicenter, randomized, intrapatient-controlled trial recruited patients 18 to 65 years of age with ECRSwNP who required surgery. Ninety-eight patients were enrolled and randomly implanted with absorbable steroid-eluting stents containing mometasone furoate in one sinus at the end of surgery. All patients received standard postoperative care and follow-up. The primary outcome was the Lund-Kennedy endoscopic score within 12 weeks postsurgery. Secondary outcomes included nasal symptoms scores, nasal resistance, acoustic rhinometry, nasal nitric oxide levels, 3-dimensional volumetric computed tomography scores, and eosinophil counts in the ethmoid mucosa.. Ninety-five patients completed the trial. At postoperative weeks 4, 8, and 12, the Lund-Kennedy scores were significantly lower on the treatment side than on the control side (all p < 0.01). Compared with the treatment side, the control side exhibited higher tissue eosinophilia at week 4 and higher volumetric, nasal obstruction, and total nasal symptom scores at postoperative week 8 (p = 0.011, p = 0.011, p < 0.01, and p = 0.001, respectively). No adrenal cortical suppression or serious side effects were observed.. Steroid-eluting stents reduce postoperative sinus mucosal edema, and eosinophilic inflammation, with persistent effects after stent disintegration, and are a good supplementary postsurgical treatment in patients with ECRSwNP.

Topics: Chronic Disease; Drug-Eluting Stents; Humans; Mometasone Furoate; Nasal Polyps; Neoplasm Recurrence, Local; Prospective Studies; Rhinitis; Sinusitis; Treatment Outcome

Chronic rhinosinusitis with nasal polyps (CRSwNP) is associated with asthma, particularly of late onset. Current treatment options for CRSwNP have limitations, and there is an unmet need for other safe and effective therapies.. The aim of the THUNDER study was to determine the efficacy and safety of the prostaglandin D. THUNDER was a phase 3b, randomized, multicenter, double-blind, placebo-controlled, parallel-group, 16-week study of fevipiprant 150 mg or 450 mg once daily versus placebo. All patients received intranasal mometasone furoate 200 μg daily.. Ninety-eight patients were randomly assigned to fevipiprant 150 mg (n = 32), fevipiprant 450 mg (n = 34), or placebo (n = 32). Mean (SE) change from baseline in nasal polyp score at week 16 was 0.20 (0.224) for fevipiprant 150 mg, -0.10 (0.216) for fevipiprant 450 mg, and 0.14 (0.233) for placebo. Mean treatment difference was 0.05 (95% confidence interval, -0.59, 0.70; adjusted P = .979) for fevipiprant 150 mg versus placebo and -0.25 (95% confidence interval, -0.88, 0.39; adjusted P = .656) for fevipiprant 450 mg versus placebo. There was no meaningful difference in the secondary end points for fevipiprant versus placebo.. THUNDER provided no evidence of a role for fevipiprant in the treatment of patients with CRSwNP and asthma; future studies may establish a role for other DP

Topics: Asthma; Chronic Disease; Double-Blind Method; Humans; Indoleacetic Acids; Mometasone Furoate; Nasal Polyps; Pyridines; Rhinitis; Sinusitis; Treatment Outcome

The efficacy of topical corticosteroids is limited in chronic rhinosinusitis (CRS) due to rapid clearance from the nasal cavity and insufficient drug delivery to inflamed sinonasal passages. LYR-210 is an implantable corticosteroid matrix designed to provide up to 24 weeks of treatment to patients with CRS by locally delivering mometasone furoate (MF) to the sinonasal mucosa. In a randomized, controlled, dose-ranging LANTERN study, LYR-210 (7500 µg) achieved clinically relevant improvement in CRS cardinal symptom composite scores, the 22-item Sinonasal Outcome Test (SNOT-22), ethmoid opacification, and the need for rescue treatment at 24 weeks.. As the plasma MF concentrations of LYR-210 (2500 µg) and LYR-210 (7500 µg) were evaluated at weeks 4, 12, and 24 in the LANTERN study (data on file at Lyra Therapeutics, Inc.), this study aims to characterize the pharmacokinetic profiles of both doses of LYR-210 at earlier timepoints post-placement in patients with CRS.. Twenty-four surgically naïve adult patients with CRS were enrolled in an open-label, multicenter study and underwent in-office bilateral administration of LYR-210 (2500 µg) (. Both LYR-210 doses were well-tolerated with no serious adverse events. Systemic MF levels were dose-dependent and lower than reported values of other respiratory MF products. Plasma MF concentrations showed steady drug release from LYR-210 (2500 µg) and LYR-210 (7500 µg) that persisted through day 56.. LYR-210 achieved dose-dependent, continuous local MF delivery at a steady rate with low systemic exposure for months.

Topics: Adrenal Cortex Hormones; Adult; Chronic Disease; Drug Liberation; Humans; Mometasone Furoate; Pharmaceutical Preparations; Pregnadienediols; Sinusitis; Treatment Outcome

Dupilumab, which blocks the shared receptor component for interleukin-4 and interleukin-13, reduced polyp size, sinus opacification, and symptom severity, and was well tolerated in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in the SINUS-52 study (NCT02898454). We assessed dupilumab in patients enrolled at Japanese centers.. Patients on a background of mometasone furoate nasal spray, received dupilumab 300 mg every 2 weeks (q2w) for 52 weeks (Arm A); dupilumab 300 mg q2w for 24 weeks, followed by every 4 weeks (q4w) for 28 weeks (Arm B); or placebo (Arm C). Co-primary endpoints were week 24 nasal polyp score (NPS), nasal congestion (NC) score, and sinus Lund-Mackay CT (LMK-CT) scores. Symptoms, sense of smell, health-related quality of life, and safety were assessed during the 52-week treatment period.. Of 49 patients enrolled in Japan, 45 completed the study. Week 24 least squares (LS) mean improvement versus placebo were as follows: NPS (Arm A: -3.1, P < .0001; Arm B: -2.1, P = .0011); NC score (Arm A: -1.2, P < .0001; Arm B: -0.9, P < .0001); and LMK-CT (Arm A: -5.1, P = .0005; Arm B: -2.8, P = .0425). The most common treatment-emergent adverse event in dupilumab and placebo-treated patients was nasopharyngitis.. Dupilumab provided rapid, significant, and clinically meaningful improvements for patients with CRSwNP in Japan. Dupilumab was well tolerated, and safety and efficacy were consistent with the overall study population.. 2 Laryngoscope, 131:E1770-E1777, 2021.

Topics: Adult; Antibodies, Monoclonal, Humanized; Chronic Disease; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Japan; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Rhinitis; Severity of Illness Index; Sinusitis; Treatment Outcome

Allergic fungal rhinosinusitis (AFRS) is a common disorder with a high prevalence and a very high incidence of recurrence. Management includes surgery and medical treatment in the form of local and/or systemic steroids. However, some cases are resistant to the action of steroids and further treatment is warranted. Being an immune-mediated disorder, targeting IgE seems a logical step. Immunotherapy drugs acting on the IgE (e.g. omalizumab) can modify the clinical course of the disease. This study aimed at evaluating the effect of omalizumab on the clinical course of patients undergoing surgery for AFRS.. This is a two-arm prospective, randomized, single blind clinical trial among patients with AFRS. Twenty patients were included and randomly divided into two groups: Group A; 10 patients received a single subcutaneous injection of omalizumab (Xolair ' Novartis) (150 mg) 2 weeks postoperatively. Group B: 10 patients received local steroids nasal sprays (budesonide or mometasone furoate, 100 μg twice daily for 6 months, starting 2 weeks postoperatively. All patients underwent history, examination, CT scan and IgE level estimation and were submitted to endoscopic sinus surgery. They were evaluated at 4 weeks interval for 6 months.. In both groups there were highly significant differences between pre/post-operative SNOT-20 scores, TNSS scores, total IgE level and Philpott-Javer staging scores. Comparison between the two study groups at 24 weeks showed a highly significant difference (p = 0.001) between post-operative SNOT 20 and TNSS scores in favour of group A. There was no statistically significant difference between the two study groups as regarding postoperative total IgE or Philpott-Javer scores. There were two recurrences in both arms, but no significant side effects.. We compared a single post operative injection of omalizumab with twice daily intranasal steroid spray for 6 months. Both treatments were effective, but the omalizumab group showed a more significant clinical and endoscopic response. There were no significant side effects in both arms. This novel approach used a single low dose injection of omalizumab increased the compliance of the patients with minimal complications. Longer follow-up of the patients is ongoing to determine the optimal time for re-injection. The only downside was the higher cost of omalizumab compared to that of local steroids.

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Allergic Agents; Budesonide; Chronic Disease; Endoscopy; Female; Glucocorticoids; Health Status Indicators; Humans; Immunoglobulin E; Injections, Subcutaneous; Male; Mometasone Furoate; Mycoses; Nasal Polyps; Nasal Sprays; Omalizumab; Prospective Studies; Rhinitis, Allergic; Single-Blind Method; Sinusitis; Tomography, X-Ray Computed; Young Adult

Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by IgE hyperproduction and eosinophilic inflammation. The anti-IgE antibody, omalizumab, has demonstrated efficacy in patients with CRSwNP and comorbid asthma previously.. Our aim was to determine omalizumab safety and efficacy in CRSwNP in phase 3 trials (POLYP 1 and POLYP 2).. Adults with CRSwNP with inadequate response to intranasal corticosteroids were randomized (1:1) to omalizumab or placebo and intranasal mometasone for 24 weeks. Coprimary end points included change from baseline to week 24 in Nasal Polyp Score (NPS) and Nasal Congestion Score. Secondary end points included change from baseline to week 24 in Sino-Nasal Outcome Test-22 (SNOT-22) score, University of Pennsylvania Smell Identification Test, sense of smell, postnasal drip, runny nose, and adverse events.. Patients in POLYP 1 (n = 138) and POLYP 2 (n = 127) exhibited severe CRSwNP and substantial quality of life impairment evidenced by a mean NPS higher than 6 and SNOT-22 score of approximately 60. Both studies met both the coprimary end points. SNOT-22 score, University of Pennsylvania Smell Identification Test score, sense of smell, postnasal drip, and runny nose were also significantly improved for omalizumab versus placebo. In POLYP 1 and POLYP 2, the mean changes from baseline at week 24 for omalizumab versus placebo were as follows: NPS, -1.08 versus 0.06 (P < .0001) and -0.90 versus -0.31 (P = .0140); Nasal Congestion Score, -0.89 versus -0.35 (P = .0004) and -0.70 versus -0.20 (P = .0017); and SNOT-22 score, -24.7 versus -8.6 (P < .0001) and -21.6 versus -6.6 (P < .0001). Adverse events were similar between groups.. Omalizumab significantly improved endoscopic, clinical, and patient-reported outcomes in severe CRSwNP with inadequate response to intranasal corticosteroids, and it was well tolerated.

Topics: Adrenal Cortex Hormones; Adult; Anti-Allergic Agents; Chronic Disease; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Omalizumab; Rhinitis; Sinusitis; Treatment Outcome

Chronic rhinosinusitis with nasal polyposis (CRSwNP) negatively affects health-related quality of life (HRQoL). In a previously reported randomized clinical trial (NCT01920893), addition of dupilumab to mometasone furoate in patients with CRSwNP refractory to intranasal corticosteroids (INCS) significantly improved endoscopic, radiographic, and clinical endpoints and patient-reported outcomes. The objective of this analysis was to examine the impact of dupilumab treatment on HRQoL and productivity using secondary outcome data from this trial.. Following a 4-week mometasone furoate nasal spray run-in, patients were randomized to commence subcutaneous dupilumab (600 mg loading dose, then 300 mg once weekly for 15 weeks [n = 30], or matched placebo [n = 30]). Outcomes included scores on the CRS disease severity visual analog scale (VAS), 22-item Sino-Nasal Outcome Test (SNOT-22), 5-dimension EuroQoL (EQ-5D) general health status VAS, and 36-item Short-Form Health Survey (SF-36) for HRQoL and nasal polyp-related healthcare resource use questionnaires.. Following 16 weeks of treatment, the proportion of patients with moderate-to-severe CRSwNP (VAS > 3-10) decreased from 86.2% to 21.4% with dupilumab and 88.0% to 84.2% with placebo. Dupilumab (vs placebo) resulted in significantly greater improvement in HRQoL, based on SNOT-22, SF-36, and EQ-5D VAS scores. The dupilumab group had a significantly lower adjusted annualized mean number of sick leave days (0.09, vs 4.18 with placebo, P = .015) and significantly greater improvement (vs placebo) in the SNOT-22 item "reduced productivity.". In adults with CRSwNP refractory to treatment with INCS alone, the addition of dupilumab reduced disease severity, significantly improved HRQoL, and improved productivity.

Topics: Adult; Anti-Inflammatory Agents; Antibodies, Monoclonal, Humanized; Chronic Disease; Double-Blind Method; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Patient Reported Outcome Measures; Quality of Life; Rhinitis; Sinusitis; Treatment Outcome

Bioabsorbable steroid-releasing implants (mometasone furoate, 370 μg) are effective for improving postsurgical outcomes in the frontal sinus ostia (FSO). In this study we evaluated the effect of these implants on frontal outcomes in various patient subgroups with chronic rhinosinusitis (CRS) using pooled data from 2 randomized, controlled trials (RCTs).. A total of 160 subjects were enrolled in 2 RCTs. After surgery, subjects were randomized to receive an implant in 1 FSO with the contralateral side as control. Data through day 90 from the 2 studies were pooled and subgroup analyses were performed.. At day 30, relative to controls, steroid-releasing implants significantly reduced the need for postoperative interventions by 46.8% (95% confidence interval [CI], -60.7 to -27.9), for surgical interventions by 51.2% (95% CI, -68.2 to -25.2), and for oral steroid interventions by 37.2% (95% CI, -54.6 to -13.1) in the pooled data set. At day 90, statistically significant reductions (p < 0.05) in the need for postoperative interventions (relative reduction [RR], 30.2%), restenosis/occlusion rate (RR, 31.7%), and inflammation score (absolute difference, -6.0), and increase in estimated FSO diameter (absolute difference, 1 mm), favoring the treated side, were observed. Subgroup analyses of the pooled data showed statistically significant improvements (p < 0.05) at day 90 in restenosis/occlusion rate, and estimated FSO diameter, favoring the treated side across subgroups, with no statistically significant subgroup-by-treatment interactions.. Bioabsorbable steroid-releasing sinus implants improve outcomes of frontal sinus surgery through 90 days, irrespective of asthma status, previous endoscopic sinus surgery, extent of surgery, extent of polyps, or Lund-Mackay computed tomography stage in the FSO.

Topics: Absorbable Implants; Adult; Aged; Chronic Disease; Drug Implants; Female; Frontal Sinus; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Rhinitis; Sinusitis; Treatment Outcome

Chronic rhinosinusitis (CRS) patients who fail medical management have few treatment options other than endoscopic sinus surgery (ESS). A novel biodegradable mometasone furoate drug delivery system (LYR-210) providing continuous topical steroid therapy to sinonasal mucosa over 24 weeks was developed to treat unoperated CRS patients who have failed medical management prior to ESS. LYR-210 was designed to slowly expand in the middle meatus, ensuring efficient drug delivery as mucosal swelling reduces.. A prospective, multicenter, open-label study was conducted in 20 CRS subjects who were determined to be candidates for ESS. Under endoscopic guidance and topical anesthesia, LYR-210 was placed in both middle meatuses. The primary endpoint was product-related serious adverse events (SAEs) at 4 weeks. Additional assessments included plasma drug concentration, morning serum cortisol levels, intraocular pressures (IOPs), and Sino-Nasal Outcome Test (SNOT-22) scores.. LYR-210 was successfully placed bilaterally in 20 subjects (12 without nasal polyps and 8 with polyps) in an office setting. There were no product-related SAEs through 24 weeks, at which point 86% of LYR-210 depots were still retained in the middle meatus. Serum cortisol, IOP, and plasma drug concentrations supported systemic safety at all time points tested. Subjects experienced significant reductions in their SNOT-22 scores as early as week 1, and this reduction persisted through week 24 (p < 0.01). Significant symptom improvement was achieved in the SNOT-22 rhinologic, extranasal rhinologic, ear-facial, psychological, and sleep dysfunction subdomains at 24 weeks (p < 0.05).. LYR-210 is safe and well-tolerated in ESS-naive CRS patients and leads to sustained symptom improvement in patients.

Topics: Adult; Aged; Anti-Inflammatory Agents; Chronic Disease; Drug Delivery Systems; Drug Liberation; Female; Humans; Male; Middle Aged; Mometasone Furoate; Rhinitis; Sinusitis; Treatment Outcome; Young Adult

Long-term, low-dose macrolide treatment has been in recent use to treat chronic rhinosinusitis. In this study, we investigated the effect of long-term, low-dose erythromycin on patients who had persistent rhinosinusitis after functional endoscopic sinus surgery (FESS).. Patients with persistent rhinosinusitis for 3 months after FESS were recruited and randomly assigned to two groups. Patients in the erythromycin group took erythromycin (250 mg twice a day) for 12 weeks, while those in the intranasal steroid group were administered with mometasone furoate nasal spray for 12 weeks. Both before and after treatment, sino-nasal symptoms were assessed via questionnaires. Patients also received an endoscopic examination, acoustic rhinometry, smell test, and saccharine transit test. A bacterial culture was obtained from the middle meatus.. Seventy-two patients completed the study, with 35 in the erythromycin group and 37 in the intranasal steroid group. Endoscopic scores decreased significantly after treatment in both groups. Erythromycin improved the smell threshold and saccharine transit time better than the intranasal steroid. In contrast, the intranasal steroid increased the second minimal cross-sectional area of the nasal cavity at a level greater than erythromycin had.. Our study showed that long-term, low-dose erythromycin treatment improved the endoscopic score, smell threshold, and saccharine transit time in patients with persistent rhinosinusitis after FESS.

Topics: Adult; Aged; Anti-Bacterial Agents; Chronic Disease; Endoscopy; Erythromycin; Female; Humans; Male; Middle Aged; Mometasone Furoate; Paranasal Sinuses; Rhinitis; Sinusitis

Topical intranasal corticosteroid sprays (INCSs) are standard treatment for nasal polyps (NPs), but their efficacy is reduced by poor patient compliance and impaired access of drug to the sinus mucosa. A corticosteroid-eluting sinus implant was designed to address these limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 μg of mometasone furoate (MF) directly to the ethmoid sinus mucosa over approximately 90 days.. A randomized, sham-controlled, double-blind trial was undertaken in 300 adults with refractory chronic rhinosinusitis with NPs (CRSwNP), who were candidates for repeat surgery. Eligible patients were randomized (2:1) and underwent in-office bilateral placement of 2 implants or a sham procedure. All patients used the MF INCS 200 μg once daily. Co-primary efficacy endpoints were the change from baseline in nasal obstruction/congestion score and bilateral polyp grade, as determined by an independent panel based on centralized, blinded videoendoscopy review.. Patients treated with implants experienced significant reductions in both nasal obstruction/congestion score (p = 0.0074) and bilateral polyp grade (p = 0.0073) compared to controls. At day 90, implants were also associated with significant reductions in 4 of 5 prespecified secondary endpoints compared to control: proportion of patients still indicated for repeat sinus surgery (p = 0.0004), percent ethmoid sinus obstruction (p = 0.0007), nasal obstruction/congestion (p = 0.0248), and decreased sense of smell (p = 0.0470), but not facial pain/pressure (p = 0.9130). One patient experienced an implant-related serious adverse event (epistaxis).. Significant improvements over a range of subjective and objective endpoints, including a reduction in the need for sinus surgery by 61%, suggest that MF sinus implants may play an important role in management of recurrent NP.

Topics: Adult; Chronic Disease; Double-Blind Method; Drug Implants; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Mucosa; Nasal Polyps; Paranasal Sinuses; Placebos; Recurrence; Sinusitis

Postoperative care is an important factor affecting the outcome of endoscopic sinus surgery (ESS) in patients with chronic rhinosinusitis (CRS). The aim of this study was to test the effect of mometasone furoate (MF)-soaked biodegradable nasal dressings (BNDs) on endoscopic appearance in CRS patients with nasal polyps (CRSwNP) after ESS.. This study was a prospective, randomized, double-blinded, placebo-controlled study. A total of 64 CRSwNP patients with bilateral ESS were enrolled and randomly given 4 mL or 8 mL of MF-soaked BNDs (NasoPore) in 1 nasal cavity and the same amount of normal saline-soaked BNDs in the contralateral side. The BNDs were removed on the 7th or 14th postoperative day. Perioperative sinus endoscopy (POSE) and Lund-Kennedy scores were collected, on the 7th or 14th postoperative days and at 1, 2, and 3 postoperative months.. The POSE and Lund-Kennedy scores showed that in the 4-mL, 1-week group, no significant differences between the sides treated with MF-soaked BNDs and the normal saline-soaked control were observed at any postoperative visits. In the 4-mL, 2-week group, significant differences were found at the 2-week and 1-month postoperative visits but not at the 2-month and 3-month visits. In the 8-mL, 1-week group, significant differences were found at the 1-week, 1-month, and 2-month postoperative visits but not at the 3-month visit. In the 8-mL, 2-week group, significant differences were found at all postoperative visits.. This study reveals that MF-impregnated BNDs improve the endoscopic appearance in the healing process of CRSwNP after ESS.

Topics: Administration, Intranasal; Adult; Aged; Anti-Inflammatory Agents; Bandages; Chronic Disease; Double-Blind Method; Endoscopy; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nasal Surgical Procedures; Paranasal Sinuses; Rhinitis; Sinusitis; Wound Healing; Young Adult

We have conducted an open label, non-comparative study in order to assess the efficacy and tolerability of Dexyane Med in combination with corticosteroids in patients with chronic hand eczema (CHE) and contact eczema (CE) in a real-life setting.. Twenty patients, 10 with CHE and 10 with CE, have been enrolled in the study. After the enrollment and the baseline evaluation, patients were treated with topical mometasone once daily and Dexyane Med once daily for one week, followed by Dexyane Med twice daily for three weeks. After the enrollment visit, patients were seen at the end of treatment, after four weeks. A telephone contact was foreseen at the second week. During the visits, mTLSS Score (CHE patients only), IGA Score and VAS for pruritus and pain were calculated. Patients' satisfaction was recorded during the phone contact after two weeks of treatment and at the final visit. Tolerability was evaluated at the end of the study.. All patients experienced a remarkable improvement in mTLSS Score, IGA Score (from a mean of 2.8 to 0.5) and VAS (from 4.5 to 0.6 for pruritus and from 2.9 to 0.3 for pain). The treatment was well tolerated and all patients were satisfied or very satisfied either at the second week or at the end of the study.. Our study has shown that the treatment of chronic hand eczema and contact eczema with a medical device administered twice a day for three weeks, following a one week treatment in combination with a topical corticosteroid, is effective in decreasing the burden of symptoms and well tolerated. To confirm our data, further controlled trials are warranted in order to explore the efficacy and tolerability of Dexyane Med in different types of eczema.

Topics: Adrenal Cortex Hormones; Adult; Chronic Disease; Dermatitis, Contact; Dermatologic Agents; Drug Therapy, Combination; Eczema; Equipment and Supplies; Female; Hand Dermatoses; Humans; Male; Mometasone Furoate; Pain; Pain Measurement; Patient Satisfaction; Pruritus; Treatment Outcome

Dupilumab has demonstrated efficacy in patients with asthma and atopic dermatitis, which are both type 2 helper T-cell-mediated diseases.. To assess inhibition of interleukins 4 and 13 with dupilumab in patients with chronic sinusitis and nasal polyposis.. A randomized, double-blind, placebo-controlled parallel-group study conducted at 13 sites in the United States and Europe between August 2013 and August 2014 in 60 adults with chronic sinusitis and nasal polyposis refractory to intranasal corticosteroids with 16 weeks of follow-up.. Subcutaneous dupilumab (a 600 mg loading dose followed by 300 mg weekly; n = 30) or placebo (n = 30) plus mometasone furoate nasal spray for 16 weeks.. Change in endoscopic nasal polyp score (range, 0-8; higher scores indicate worse status) at 16 weeks (primary end point). Secondary end points included Lund-Mackay computed tomography (CT) score (range, 0-24; higher scores indicate worse status), 22-item SinoNasal Outcome Test score (range, 0-110; higher scores indicating worse quality of life; minimal clinically important difference ≥8.90), sense of smell assessed using the University of Pennsylvania Smell Identification Test (UPSIT) score (range, 0-40; higher scores indicate better status), symptoms, and safety.. Among the 60 patients who were randomized (mean [SD] age, 48.4 years [9.4 years]; 34 men [56.7%]; 35 with comorbid asthma), 51 completed the study. The least squares (LS) mean change in nasal polyp score was -0.3 (95% CI, -1.0 to 0.4) with placebo and -1.9 (95% CI, -2.5 to -1.2) with dupilumab (LS mean difference, -1.6 [95% CI, -2.4 to -0.7]; P < .001). The LS mean difference between the 2 groups for the Lund-Mackay CT total score was -8.8 (95% CI, -11.1 to -6.6; P < .001). Significant improvements with dupilumab were also observed for the 22-item SinoNasal Outcome Test (LS mean difference between groups, -18.1 [95% CI, -25.6 to -10.6]; P < .001) and sense of smell assessed by UPSIT (LS mean difference, 14.8 [95% CI, 10.9 to 18.7]; P < .001). The most common adverse events were nasopharyngitis (33% in the placebo group vs 47% in the dupilumab group), injection site reactions (7% vs 40%, respectively), and headache (17% vs 20%).. Among adults with symptomatic chronic sinusitis and nasal polyposis refractory to intranasal corticosteroids, the addition of subcutaneous dupilumab to mometasone furoate nasal spray compared with mometasone alone reduced endoscopic nasal polyp burden after 16 weeks. Further studies are needed to assess longer treatment duration, larger samples, and direct comparison with other medications.. clinicaltrials.gov Identifier: NCT01920893.

Topics: Adult; Aged; Anti-Inflammatory Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Asthma; Chronic Disease; Double-Blind Method; Drug Administration Schedule; Female; Humans; Injections, Subcutaneous; Interleukin-13; Interleukin-4; Least-Squares Analysis; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Quality of Life; Sinusitis

Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometasone furoate for 3 months. Here we summarize longer-term outcomes.. A randomized, controlled, blinded study with 100 chronic rhinosinusitis with nasal polyps (CRSwNP) patients who failed medical treatment and were considered candidates for revision ESS. Treated patients (n = 57) underwent in-office implant placement. Control patients (n = 43) underwent a sham procedure. Endoscopic grading at 3 months by clinicians was corroborated by an independent review of randomized videoendoscopies by a panel of 3 sinus surgeons. Six-month follow-up included endoscopic grading and patient-reported outcomes.. At 6 months, treated patients experienced significant improvement in Nasal Obstruction Symptom Evaluation (NOSE) score (p = 0.021) and >2-fold improvement in mean nasal obstruction/congestion score (-1.06 ± 1.4 vs -0.44 ± 1.4; p = 0.124). Endoscopically, treated patients experienced significant reduction in ethmoid sinus obstruction (p < 0.001) and bilateral polyp grade (p = 0.018) compared to controls. Panel review confirmed a significant reduction in ethmoid sinus obstruction (p = 0.010) and 2-fold improvement in bilateral polyp grade (p = 0.099), which reached statistical significance (p = 0.049) in a subset of 67 patients with baseline polyp burden ≥2 bilaterally. At 6 months, control patients were at 3.6 times higher risk of remaining indicated for ESS than treated patients.. The symptomatic and endoscopic improvements observed confirm the efficacy of the steroid-eluting implant for in-office treatment of CRSwNP after ESS. These longer-term 6-month study results demonstrate that the steroid-eluting implant represents a durable, safe, and effective treatment strategy for this patient population.

Topics: Absorbable Implants; Ambulatory Care; Anti-Inflammatory Agents; Chronic Disease; Endoscopy; Humans; Mometasone Furoate; Nasal Polyps; Paranasal Sinuses; Patient Reported Outcome Measures; Recurrence; Reoperation; Rhinitis; Sinusitis; Treatment Outcome

Chronic sinonasal disease is common in asthmatic patients and associated with poor asthma control; however, there are no long-term trials addressing whether chronic treatment of sinonasal disease improves asthma control.. We sought to determine whether treatment of chronic sinonasal disease with nasal corticosteroids improves asthma control, as measured by the Childhood Asthma Control Test and Asthma Control Test in children and adults, respectively.. A 24-week multicenter, randomized, placebo-controlled, double-blind trial of placebo versus nasal mometasone in adults and children with inadequately controlled asthma was performed. Treatments were randomly assigned, with concealment of allocation.. Two hundred thirty-seven adults and 151 children were randomized to nasal mometasone versus placebo, and 319 participants completed the study. There was no difference in the Childhood Asthma Control Test score (difference in change with mometasone - change with placebo [ΔM - ΔP], -0.38; 95% CI, -2.19 to 1.44; P = .68; age 6-11 years) or the Asthma Control Test score (ΔM - ΔP, 0.51; 95% CI, -0.46 to 1.48; P = .30; age ≥12 years) in those assigned to mometasone versus placebo. In children and adolescents (age 6-17 years) there was no difference in asthma or sinus symptoms but a decrease in episodes of poorly controlled asthma defined by a decrease in peak flow. In adults there was a small difference in asthma symptoms measured by using the Asthma Symptom Utility Index (ΔM - ΔP, 0.06; 95% CI, 0.01 to 0.11; P < .01) and in nasal symptoms (sinus symptom score ΔM - ΔP, -3.82; 95% CI, -7.19 to -0.45; P = .03) but no difference in asthma quality of life, lung function, or episodes of poorly controlled asthma in adults assigned to mometasone versus placebo.. Treatment of chronic sinonasal disease with nasal corticosteroids for 24 weeks does not improve asthma control. Treatment of sinonasal disease in asthmatic patients should be determined by the need to treat sinonasal disease rather than to improve asthma control.

Topics: Administration, Intranasal; Adolescent; Adult; Anti-Inflammatory Agents; Asthma; Child; Chronic Disease; Double-Blind Method; Female; Humans; Male; Middle Aged; Mometasone Furoate; Paranasal Sinuses; Pregnadienediols; Quality of Life; Respiratory Function Tests; Treatment Outcome

This study assessed efficacy of clarithromycin "long-term" macrolide therapy as an adjunct to maintenance therapy with nasal corticosteroids to prevent recurrence of nasal polyps (NP) after functional endoscopic sinus surgery (FESS).. A total of 66 patients with chronic rhinosinusitis and bilateral NP were randomized into 3 study arms, 22 patients in each arm. After FESS, patients in the first and second groups were treated with clarithromycin 250 mg/day for 12 and 24 weeks, respectively, whereas patients in the third group did not receive any clarithromycin. Patients in all 3 groups received maintenance therapy with mometasone furoate 400 μg/day. Patient assessment was conducted before the surgery and 6, 12, and 24 weeks after surgery, using a visual analogue scale (VAS), 20-item SinoNasal Outcome Test (SNOT-20), acoustic rhinometry, rhinomanometry, saccharin transit time, nasal endoscopy, computed tomography (CT) of paranasal sinuses, and measurement of the level of eosinophil cationic protein (ECP) in their nasal secretions.. The study confirmed efficacy of "long-term" macrolide therapy, resulting in significant improvement of all parameters except acoustic rhinometry and VAS in both clarithromycin groups as compared to the control. Concentration of ECP in the nasal secretions increased dramatically after surgery, then returned to baseline levels after 12 and 24 weeks of treatment with clarithromycin. In the control group, ECP level continued to increase and was significantly higher at the endpoint. Both groups with clarithromycin showed significantly better endoscopic and CT scores than the control group at the end point.. "Long-term" low-dose clarithromycin 250 mg/day is able to control eosinophilic inflammation and prevent early relapse of NP after FESS.

Topics: Adrenal Cortex Hormones; Adult; Chemotherapy, Adjuvant; Chronic Disease; Clarithromycin; Endoscopy; Eosinophil Cationic Protein; Female; Follow-Up Studies; Humans; Male; Mometasone Furoate; Nasal Polyps; Paranasal Sinuses; Pregnadienediols; Recurrence; Rhinitis; Rhinomanometry; Sinusitis; Tomography, X-Ray Computed; Treatment Outcome

Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. This study evaluated the safety and efficacy of a bioabsorbable steroid-eluting implant with 1350 μg of mometasone furoate for its ability to dilate obstructed ethmoid sinuses, reduce polyposis, and reestablish sinus patency.. This was a randomized, controlled, blinded study including 100 patients chronic rhinosinusitis with nasal polyposis (CRSwNP) refractory to medical therapy and considered candidates for revision ESS. Follow-up included endoscopic grading by investigators and patient-reported outcomes.. Treated patients (n = 53; age as mean ± standard deviation [SD] 47.8 ± 12.6 years; 55% male) underwent in-office bilateral placement. Control patients (n = 47; age 51.6 ± 13.1 years; 66% male) underwent a sham procedure. At 3 months, treated patients experienced a significant reduction in bilateral polyp grade (p = 0.0269) and ethmoid sinus obstruction (p = 0.0001) compared to controls. Treated patients also experienced a 2-fold improvement in the mean nasal obstruction/congestion score (-1.33 ± 1.47 vs -0.67 ± 1.45; p = 0.1365). This improvement reached statistical significance (p = 0.025) in patients with greater polyp burden (grade ≥2 bilaterally; n = 74). At 3 months, 53% of treated patients compared to only 23% of controls were no longer indicated for repeat ESS. There was no serious adverse event or clinically significant increases in intraocular pressure or cataract formation.. The symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS. The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population.

Topics: Absorbable Implants; Ambulatory Surgical Procedures; Anti-Inflammatory Agents; Chronic Disease; Drug Implants; Endoscopy; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Pregnadienediols; Prosthesis Design; Recurrence; Rhinitis; Sinusitis; Treatment Outcome

Erdosteine was originally developed as a mucolytic agent. It is a multimechanism substance with anti-bacterial, anti-oxidant, and most importantly anti-inflammatory effects. Given similar mechanisms of action (suppression of cytokines, including tumor necrosis factor α), it could become a reasonable alternative to currently used treatments with macrolides or steroids.. To assess efficacy and safety of erdosteine in the treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP).. A prospective non-interventional post-authorisation study comparing patients treated with erdosteine only or the combination of erdosteine and nasal corticosteroid spray for CRSwNP. The end-points were pre- and post-treatment changes in endoscopic score and subjective evaluation of CRSwNP related symptoms using a 22-item Sinonasal Outcome Test questionnaire. Patients underwent nasal endoscopy and filled the questionnaire before and after the treatment.. No patient experienced any adverse effect during the study. A comparison of pre- and post-treatment endoscopic findings and questionnaire values revealed significant reduction in both patient groups, with a significantly better response in the erdosteine only group.. Based on this pilot study, erdosteine seems effective in the treatment of CRSwNP and might become a reasonable alternative to currently used medication. The therapeutical role of erdosteine needs to be further assessed.

Topics: Adult; Aged; Anti-Inflammatory Agents; Chronic Disease; Drug Therapy, Combination; Expectorants; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Pilot Projects; Pregnadienediols; Prospective Studies; Rhinitis; Sinusitis; Thioglycolates; Thiophenes; Treatment Outcome; Young Adult

Topics: Administration, Topical; Adult; Anti-Bacterial Agents; Anti-Inflammatory Agents; Chronic Disease; Cohort Studies; Combined Modality Therapy; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nebulizers and Vaporizers; Pregnadienediols; Rhinitis; Sinusitis

The aim of this study was to investigate the prevalence of biofilms and the effects of medical treatment modalities in chronic rhinosinusitis (CRS) patients without nasal polyps.. Randomized controlled trial.. Tertiary referral hospital.. The authors randomly divided 32 adult patients with CRS without nasal polyps into 2 groups. In the first group (n = 16), oral clarithromycin was administered 500 mg/bid for 2 weeks and then 250 mg/d for the following 6 weeks. In the second group (n = 16), an 8-week course of 200-mcg/d topical mometasone furoate was added to the clarithromycin regimen, identical to the first group. The pre- and posttreatment nasal tissue samples were evaluated by scanning electron microscopy for biofilm prevalence and graded from 0 to 3 according to density and extension.. Biofilms were detected in 24 of 32 patients (75%) before the treatment (grades 1-3). Biofilms were detected in 14 of 32 patients (43.8%) after the treatment (grades 1-2). When each group was evaluated independently, there was a significant improvement after the treatment in both groups I and II. When the biofilm grades of group I were compared to those of group II, there was no significant difference both in the pre- and posttreatment evaluation.. The prevalence of biofilms in CRS without polyps was 75% in our study. Regression of biofilms to 43% was observed under medical treatment. Adding nasal steroids to macrolides gave no further benefit.

Topics: Administration, Oral; Administration, Topical; Adult; Anti-Bacterial Agents; Anti-Inflammatory Agents; Biofilms; Biopsy; Chronic Disease; Clarithromycin; Female; Humans; Male; Microscopy, Electron, Scanning; Middle Aged; Mometasone Furoate; Pregnadienediols; Prevalence; Rhinitis; Sinusitis; Statistics, Nonparametric

This study evaluated the efficacy and safety of mometasone furoate nasal spray (MFNS) in patients with chronic sinusitis.. In this double-blind, placebocontrolled, multicenter, parallel-group study, 60 patients with persistent sinusitis symptoms were randomized to receive either MFNS 200 μg twice daily or placebo, for 16 weeks (112 days). Eventually, 53 patients terminated the study in regular course.. Total Symptom Scores (TSS) in patients receiving MFNS changed by a mean of -7.27 (95% CI -9.71, -4.84), versus -5.35 (95% CI -6.73, -3.96) in the placebo group (P=0.51). MFNS reduced nasal congestion and discharge scores, and improved patients' olfactory function. There were few side effects. Considerably more patients in the MFNS group were satisfied with the treatment than those who had received placebo (P<0.05). Also, more patients would take the medication again in the event of symptoms, compared with those who had taken placebo (P<0.05). Furthermore, the MFNS patients would recommend it to others.. The positive patient assessment and few side effects are reflected in the efficacy evaluation performed by the physicians. The endoscopic results under MFNS were always numerically more favorable than those under placebo, and the overall difference reached statistical significance (P<0.01). MFNS offers an effective and safe treatment for chronic rhinosinusitis.

Topics: Adult; Anti-Inflammatory Agents; Chronic Disease; Double-Blind Method; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Mucosa; Nasal Sprays; Pregnadienediols; Rhinitis; Sinusitis; Treatment Outcome; Young Adult

The efficacy of oral montelukast in chronic asthma is well established. Montelukast is also an effective adjunctive therapy to inhaled corticosteroids (ICS) in asthma uncontrolled on ICS alone. Inhaled montelukast was recently shown to provide significant bronchodilation compared with placebo in patients with chronic asthma. The purpose of this study was to evaluate the efficacy of inhaled montelukast added to inhaled mometasone.. This was an 8-week, multicenter, randomized, double-blind, placebo-controlled study comparing once-daily inhaled montelukast 1 mg plus inhaled mometasone 220 μg (delivered by separate dry powder inhalers) with placebo plus inhaled mometasone 220 μg. Men and women aged 15-85 years with chronic asthma, forced expiratory volume in 1 second (FEV(1)) 50-80% of the predicted value, and β-agonist reversibility ≥12% were eligible. Patients were required to meet a minimum symptom threshold while receiving open-label inhaled mometasone during a 3-week prestudy/run-in period. Patients received blinded (montelukast vs. placebo) treatment for 2 weeks, entered a 1-week washout period, then crossed over to the other treatment for 2 weeks. The primary endpoint was the average change from baseline in FEV(1) over the 2-week treatment period. Secondary endpoints included daytime and nighttime symptom scores. Other endpoints included short-acting β-agonist (SABA) use, asthma exacerbations, asthma control, peak expiratory flow (PEF), and blood eosinophil count.. A total of 134 patients were randomized. For the primary endpoint, change from baseline in FEV(1), inhaled montelukast plus inhaled mometasone was significantly more effective than placebo plus inhaled mometasone (least squares mean 0.22 L vs. 0.17 L; p = .033 [two-sided at α = 0.05]). Inhaled montelukast plus inhaled mometasone was also significantly more effective than placebo plus inhaled mometasone in improving daytime asthma symptom scores (p = .005) and nighttime asthma symptom scores (p = .015), increasing the percentage of days with asthma control (p = .004), decreasing the percentage of days with asthma exacerbations (p ≤ .001), and decreasing the blood eosinophil count (p = .013). Differences were not significant on AM or PM PEF or SABA use, although the latter approached significance (p = .073). Both treatments were well tolerated.. Inhaled montelukast plus inhaled mometasone was significantly more effective than placebo plus inhaled mometasone in improving FEV(1), symptoms, asthma control, and blood eosinophil count.

Topics: Acetates; Administration, Inhalation; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Chronic Disease; Confidence Intervals; Cross-Over Studies; Cyclopropanes; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Forced Expiratory Volume; Humans; Linear Models; Male; Maximum Tolerated Dose; Middle Aged; Mometasone Furoate; Patient Compliance; Pregnadienediols; Quinolines; Reference Values; Risk Assessment; Severity of Illness Index; Spirometry; Sulfides; Treatment Outcome; United States; Young Adult

To compare the effect of the medical and surgical treatment of pediatric chronic rhinosinusitis (CRS).. Seventy-two cases of pediatric CRS were randomly divided into medical group (35 cases) and surgical group (37 cases). The patients in medical group received a 12-week course of clarithromycin, alkaline nasal douche and intranasal mometasone furoate. The patients in surgical group underwent adenoidectomy or (and) tonsillectomy or ESS. All patients underwent pre- and post-treatment assessments of visual analogue score (VAS) and nasal endoscopy. The assessments of CT were arranged before starting the treatment and post-treatment in 12-month.. Both groups of pediatric CRS significantly improved in VAS and endoscopic parameters of CRS in all stages. There were no significant difference between two groups in 1-month (P > 0.05). The surgical group demonstrated greater change than medical group in 3-month, 6-month and 12-month (P < 0.01). In surgical group, 37 cases underwent three different styles of operation: adenoidectomy (n = 19), adenoidectomy and tonsillectomy (n = 10) and ESS (n = 8). VAS and endoscopic parameters were not significantly different among three groups in all stages except in 1-month.. The results of this study warrant further that both medical and surgical treatment of pediatric CRS significantly improve in VAS and endoscopic parameters of CRS. The mainstay of management is medical treatment. Long-term, low-dose macrolide is an effective therapy and a valid alternative in pediatric CRS. Surgical intervention is necessary for cases that do not respond to prolonged course medical treatment. Adenoidectomy or (and) tonsillectomy seems to be a recommended surgical procedure for children with adenoid or (and) tonsil hypertrophy.

Topics: Adenoidectomy; Adolescent; Child; Chronic Disease; Clarithromycin; Female; Humans; Male; Mometasone Furoate; Pregnadienediols; Sinusitis; Tonsillectomy; Treatment Outcome

There was no significant difference in the postoperative outcomes between different surgical options for treating chronic maxillary sinusitis (CMS).. We aimed to compare the improvement in symptoms, and changes in endoscopic and CT grade in patients undergoing different surgical management of the maxillary sinus ostium.. In 32 patients (group A), the pathologic mucosa was radically removed with a power microdebrider. In 28 patients (group B), only part of the pathologic mucosa was removed; gross pathologic lesions were left in situ. In 38 patients (group C), only enlargement of the maxillary ostium was performed. Pre- and postoperative changes in symptoms, endoscopic polyp grade, and Lund-Mackay CT score were compared between groups.. In all groups, the symptoms were significantly improved after 1 month and throughout the follow-up period. Patients in groups A and B had meaningful improvement of the endoscopic polyp grade 1 month after surgery. The endoscopic grade of patients in group C at 1 and 3 months after surgery was not significantly different from the preoperative grade; however, there was a meaningful difference after 6 months. At 12 months after surgery, all groups had a significant decrease in the CT score (p < 0.01); however, there was no difference between groups.

Topics: Adolescent; Adult; Anti-Inflammatory Agents; Chronic Disease; Endoscopy; Female; Follow-Up Studies; Humans; Male; Maxillary Sinus; Maxillary Sinusitis; Middle Aged; Mometasone Furoate; Nasal Lavage; Nasal Sprays; Postoperative Care; Postoperative Complications; Pregnadienediols; Tomography, X-Ray Computed; Young Adult

Power-assisted turbinectomy is a safe and reliable alternative for patients with nasal blockage if nasal corticosteroid spray therapy is not suitable.. Powered-assisted partial turbinectomy was compared to the use of a corticosteroid nasal spray for relief of nasal obstruction in chronic or idiopathic rhinosinusitis.. Patients were randomized to either power-assisted partial turbinectomy or daily use of mometasone furoate nasal spray for 6 months. Evaluation by peak nasal inspiratory flow (PNIF) and grading of symptoms by use of visual analog scale was done after 3 and 6 months. Grading of symptoms was also done by use of a questionnaire approximately 30 months after the last visit.. PNIF scores improved for all patients, although significantly only for patients on mometasone spray. Patients' self-reported symptoms decreased more for operated patients. Side effects were few and mild in both groups.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Chronic Disease; Female; Humans; Inspiratory Capacity; Male; Middle Aged; Mometasone Furoate; Mouth Breathing; Multivariate Analysis; Nasal Obstruction; Nasal Sprays; Pregnadienediols; Quality of Life; Rhinitis; Severity of Illness Index; Sinusitis; Smell; Turbinates; Young Adult

Disease recurrence and adverse wound healing in the form of inflammation, polyposis, adhesions, and middle turbinate lateralization may induce suboptimal outcomes following sinus surgery. The study objective was to assess the safety and effectiveness of a bioabsorbable, steroid-eluting implant used following functional endoscopic sinus surgery in patients with chronic rhinosinusitis (CRS).. Prospective, multicenter, single-cohort trial enrolling 50 patients.. The study allowed bilateral or unilateral steroid-eluting implant placement. Oral and topical steroids were withheld for 60 days postoperatively. Endoscopic follow-up was performed to 60 days. Patient-reported outcomes (Sino-Nasal Outcome Test-22 Questionnaire, Rhinosinusitis Disability Index) were collected to 6 months. Efficacy was assessed by grading inflammation, polyp formation, adhesions, and middle turbinate position. Safety assessment included ocular exams at baseline and 30 days.. Implants were successfully placed in all 90 sinuses. Mean inflammation scores were minimal at all time points. At 1 month, the prevalence of polypoid edema was 10.0%, significant adhesions 1.1%, and middle turbinate lateralization 4.4%. Changes from baseline in patient-reported outcomes were statistically significant (P < .0001). No clinically significant changes from baseline in intraocular pressure occurred.. This consecutive case series provides clinical evidence of the safety, effectiveness, and clinical utility of a bioabsorbable steroid-eluting implant for use in CRS patients. The implant was associated with favorable rates of sinus patency. At 1 month, minimal degrees of inflammation and adhesions were observed, suggesting a positive clinical impact of local steroid delivery without evidence of ocular risk.

Topics: Adult; Aged; Anti-Inflammatory Agents; Chronic Disease; Drug-Eluting Stents; Endoscopy; Ethmoid Sinusitis; Feasibility Studies; Female; Follow-Up Studies; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Patient Satisfaction; Postoperative Care; Postoperative Complications; Pregnadienediols; Rhinitis; Secondary Prevention; Sinusitis; Wound Healing; Young Adult

Many patients with allergic rhinitis are reluctant to use daily intranasal steroids for prolonged periods. A self-adjusted regimen which delivers reasonable control of allergic rhinitis may be more acceptable to such patients.. To compare the efficacy of daily use of mometasone furoate nasal spray, versus a self-adjusted regimen, in patients with chronic allergic rhinitis, in terms of symptom control and nasal volume change.. Ambulatory visits in an office setting.. Sixty patients with chronic allergic rhinitis were randomised: 30 were prescribed mometasone furoate nasal spray once daily for six weeks, while 30 were prescribed the same spray daily for one week, every alternate day for one week and then on a self-adjusted regimen for four weeks. Patients kept a symptom diary documenting sneezing, rhinorrhoea, nasal blockage and nasal itching. Acoustic rhinometry was used to measure the total nasal cavity volume at the first visit and at the end of the treatment period.. The total nasal score on treatment days showed an improvement in both groups, compared with baseline measurements. There was no significant difference in total nasal scores between the two groups, except on days 10 (p = 0.043), 20 (p = 0.008), 23 (p = 0.19), 30 (p = 0.008) and 37 (p = 0.000), when the daily group's total nasal score was significantly lower than the self-adjusted group's total nasal score, and on day 8 (p = 0.004), when the self-adjusted group's total nasal score was significantly lower than the daily group's total nasal score. Total nasal cavity volume significantly increased in both groups (p = 0.0001), with no statistically significant difference between the groups.. Self-adjusted dosage of mometasone furoate nasal spray gives reasonable control of allergic rhinitis (albeit with some 'breakthrough' symptoms). Patients should learn how to control these symptoms with the least number of steroid doses.

Topics: Adult; Anti-Allergic Agents; Anti-Inflammatory Agents; Chronic Disease; Drug Administration Schedule; Female; Glucocorticoids; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Cavity; Pregnadienediols; Rhinitis, Allergic, Perennial; Self Administration

To find out whether the constant preoperative use of a topical corticoid (mometasone furoate [MF]) could really improve the operative field quality and decrease bleeding during endoscopic sinus surgery (ESS).. Double-blind, randomized controlled trial.. Tertiary referral center.. Seventy patients with chronic rhinosinusitis (CRS) with and without polyps underwent ESS under standardized general anesthesia with equal randomization into two groups. During four weeks within the preoperative period, 35 cases were treated with MF, while the other half received placebo matching sprays. Total blood loss, operation time, and surgical field quality were recorded.. Intraoperative blood loss in the MF-treated group was 142.8 mL, less than in the control group (170.6 mL). The difference between the groups is 27.7 mL (95% confidence interval [CI] 3.5-51.92), statistically significant: P = 0.025. Time of surgery was 59 minutes in the MF group and 70 minutes in the control group. The difference was 11.2 minutes (95% CI 2.82-19.51), which is statistically significant: P = 0.009. The quality of the endoscopic surgical field was significantly better for patients treated with MF. Treatment with topical corticoid enables significantly reduced bleeding, decreased operation time, and improved endoscopic vision during ESS for CRS.. The use of topical corticoid (MF) in the preoperative period can improve endoscopic vision, reduce bleeding, and decrease operation time in CRS patients with and without polyps undergoing ESS, but our sample size cannot exclude small, and possibly trivial, group differences.

Topics: Administration, Intranasal; Administration, Rectal; Adult; Anti-Inflammatory Agents; Blood Loss, Surgical; Chronic Disease; Double-Blind Method; Endoscopy; Female; Glucocorticoids; Humans; Male; Mometasone Furoate; Nasal Polyps; Paranasal Sinuses; Pregnadienediols; Preoperative Care; Rhinitis; Sinusitis

Approximately 20% patients with chronic rhinosinusitis undergoing Functional Endoscopic Sinus Surgery (FESS) experience impaired wound healing, leading to recurrences of sinusitis and polyps.. We investigated the efficacy of oral+ local steroids in wound healing, following FESS in subjects with a chronic rhinosinusitis with/without nasal polyps. Ninety-nine subjects were randomised to receive 6 months' treatment with mometasone furoate nasal spray (MFNS) 200 microg bid or placebo in double-blind manner approximately 2 weeks after FESS. Postoperative mean total score for several endoscopic parameters scores assessed at 6 months was calculated as the primary efficacy end-point. An endoscopic combination score (for inflammation, oedema, and polyps), a total symptoms score, and percent subjects requiring rescue medication, were assessed as secondary end-points.. MFNS led to greater, although not significant, reductions in total endoscopic scores in all subjects, compared with placebo. The combination scores, however, indicated significantly improved healing with MFNS than with placebo for all subjects (median scores: 0.0 vs 2.0, p = 0.02), and particularly for subjects with nasal polyps (median scores: 2.0 vs 4.0, p = 0.03). The total symptom scores and percent subjects requiring rescue medication were similar in the two groups. MFNS was well tolerated.. These results suggest that treatment with MFNS following sinus surgery may improve wound healing, particularly in subjects with nasal polyps.

Topics: Administration, Topical; Adult; Anti-Inflammatory Agents; Chronic Disease; Double-Blind Method; Endoscopy; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Pilot Projects; Pregnadienediols; Prospective Studies; Rhinitis; Sinusitis; Wound Healing; Young Adult

To determine the clinical effectiveness of topical intranasal corticosteroids in children with bilateral otitis media with effusion.. Double blind randomised placebo controlled trial.. 76 Medical Research Council General Practice Research Framework practices throughout the United Kingdom, between 2004 and 2007.. 217 children aged 4-11 years who had at least one practice recorded episode of otitis media or a related ear problem in the previous 12 months, and with bilateral otitis media with effusion confirmed by a research nurse using otoscopy plus micro-tympanometry (B/B or B/C2, modified Jerger types).. Mometasone furoate 50 microg or placebo spray given once daily into each nostril for three months.. Proportions of children cured of bilateral otitis media with effusion assessed with tympanometry (C1 or A type) at one month (primary end point), three months, and nine months; adverse events; three month diary symptoms. Results 41% (39/96) of the topical steroid group and 45% (44/98) of the placebo group were cured in one or both ears at one month (difference favouring placebo 4.3% (95% confidence interval -9.3% to 18.1%). Poisson regression was done with adjustment for four pre-specified covariates (clinical severity, P=0.003; atopy, P=0.67; age, P=0.92; season, P=0.71). The adjusted relative risk at one month was 0.97 (95% confidence interval 0.74 to 1.26). At three months, 58% of the topical steroid group and 52% of the placebo group were cured (relative risk 1.23, 0.84 to 1.80). Diary symptoms did not differ between the two groups, and no significant harms were reported.. Topical steroids are unlikely to be an effective treatment for otitis media with effusion in general practice. High rates of natural resolution occurred by 1-3 months.. Current Controlled Trials ISRCTN38988331; National Research Register NO575123823; MREC 03/11/073.

Topics: Administration, Intranasal; Anti-Inflammatory Agents; Child; Child, Preschool; Chronic Disease; Double-Blind Method; Female; Humans; Male; Mometasone Furoate; Otitis Media with Effusion; Pregnadienediols; Treatment Outcome

Once-daily dosing with an inhaled corticosteroid (ICS) may simplify asthma management and improve patient compliance. Since asthma is frequently worse at night, evening dosing appears to be a more obvious choice to accommodate the chronobiology of asthma than morning dosing.. The primary study objective was to compare the efficacy and safety of mometasone furoate (MF) dry powder inhaler (MF-DPI) 400 microg qd PM (one 400 microg inhalation) with placebo for the treatment of asthma in patients previously dependent on twice a day (bid, bis in die) ICS therapy. We also compared different regimens of MF-DPI with each other and with placebo.. This 12-week, multicenter, double-blind, placebo-controlled study evaluated lung function and asthma symptoms in 400 subjects with persistent asthma randomized to MF-DPI 200 microg qd (once a day, quaque die) PM, 400 microg qd PM as one inhalation from a 400 microg device, 400 microg qd PM as two inhalations from a 200 microg device, 200 microg twice daily (bid), or placebo. Evening doses were to be taken in the late afternoon or early evening, preferably before dinner time.. Mean changes from baseline at endpoint in FEV1 (forced expiratory volume in 1 s) were similar for MF-DPI 400 microg qd PM (one inhalation; 0.41 L), MF-DPI 400 microg qd PM (2 inhalations; 0.49 L), MF-DPI 200 microg qd PM (0.41 L), and MF-DPI 200 microg bid (0.51 L); and all were significantly improved compared with placebo (0.16 L; p < 0.001). Secondary efficacy variables, including nocturnal awakenings and use of rescue albuterol, were also significantly improved with MF-DPI treatment compared with placebo. All treatments were generally safe and well tolerated, with adverse events of mild to moderate severity.. Once-daily evening dosing of MF-DPI at doses of 400 and 200 microg restored lung function and improved nocturnal and daytime symptom control in subjects with asthma previously dependent on bid ICS therapy. Comparable effectiveness of a total daily dose of 400 microg was demonstrated between once daily in the evening and twice-daily administration. The results also confirm the effectiveness of MF-DPI 200 microg qd PM, the lowest dose studied.

Topics: Adolescent; Adrenal Cortex Hormones; Adult; Aged; Anti-Inflammatory Agents; Asthma; Chronic Disease; Disease Progression; Female; Humans; Male; Middle Aged; Mometasone Furoate; Patient Compliance; Pregnadienediols; Quality of Life; Surveys and Questionnaires; Treatment Outcome

To demonstrate the long-term efficacy of intranasal furosemide, an inhibitor of the sodium chloride cotransporter channel at the basolateral surface of the respiratory epithelial cell, vs no therapeutic intervention vs intranasal mometasone furoate, a corticosteroid, in preventing relapses of chronic hyperplastic sinusitis with nasal polyposis.. Randomized prospective controlled study. Patients were examined every 6 months during follow-up (range, 1-9 years).. One hundred seventy patients with bilateral obstructive or minimally obstructive chronic hyperplastic sinusitis with nasal polyposis.. All patients were surgically treated in the ENT Department, University of Siena Medical School. One month after surgery, group 1 patients (n = 97) started treatment with intranasal furosemide, group 2 (n = 40) received no therapeutic treatment, and group 3 (n = 33) were treated with mometasone.. Clinical and instrumental evaluation of postoperative outcomes.. Seventeen (17.5%) of 97 patients in group 1, 12 (30.0%) of 40 patients in group 2, and 8 (24.2%) of 33 patients in group 3 experienced nasal polyposis relapses. We noted a prevalence of early-stage relapse in patients treated with furosemide or mometasone, whereas patients who did not receive any treatment experienced more severe grades of chronic hyperplastic sinusitis with nasal polyposis (P<.005).. Use of intranasal furosemide represents a valid therapeutic treatment in the prevention of chronic hyperplastic sinusitis with nasal polyposis.

Topics: Administration, Intranasal; Adult; Anti-Inflammatory Agents; Chronic Disease; Diuretics; Female; Furosemide; Humans; Hyperplasia; Male; Middle Aged; Mometasone Furoate; Nasal Obstruction; Nasal Polyps; Paranasal Sinuses; Pregnadienediols; Prospective Studies; Secondary Prevention; Sinusitis; Sodium Chloride Symporters; Symporters; Treatment Outcome

Mometasone furoate (MF; Schering-Plough, Madison, NJ), is a glucocorticoid with high local potency and low potential systemic availability.. To compare the relative efficacy and safety of a new formulation of MF, coupled with a recently designed dry powder inhaler (DPI), in the treatment of patients with moderate persistent asthma. Fluticasone propionate administered by Diskhaler (FP Diskhaler, 250 microg twice a day; Glaxo Wellcome, Research Triangle Park, NC) was used as an active control.. A randomized, parallel group, double-blind (for MF-DPI dosage), evaluator-blind (for MF-DPI vs FP) trial.. Sixty centers in 20 countries.. Seven hundred thirty-three patients with moderate persistent asthma on inhaled corticosteroid treatment.. Discontinuation of previous inhaled corticosteroid and initiation of one of four study treatments: three doses of MF-DPI (100, 200, and 400 microg twice daily) and one of FP (250 microg twice daily >12 weeks).. FEV1 (primary efficacy variable) was evaluated as the mean change from baseline to endpoint (last evaluable visit). All dosage groups showed improvement at endpoint. Only 400 microg twice daily of MF-DPI (+0.19 L) was statistically different from 100 microg twice daily of MF-DPI (+0.07 L; P = 0.02). MF-DPI (200 microg twice daily) and FP Diskhaler groups showed similar improvement (+0.16 L). Greater improvement in most secondary variables (forced expiratory flow between 25% and 75% of vital capacity, and morning and evening peak expiratory flows) also resulted from treatment with 200 or 400 microg twice daily of MF-DPI or with FP Diskhaler, compared with 100 microg twice daily of MF-DPI. Overall, a total daily 800-microg dose of MF-DPI conferred no significant additional benefit >400 microg of MF-DPI. The incidence of oral candidiasis was 1%, 7%, 10%, and 10% in the 100, 200, and 400 microg twice daily of MF-DPI and FP groups, respectively.. A total daily dose of 400 microg of MF-DPI provides clinical benefit comparable to that observed with a total daily dose of 500 microg of FP Diskhaler.

Topics: Administration, Inhalation; Adolescent; Adult; Aged; Androstadienes; Anti-Asthmatic Agents; Anti-Inflammatory Agents; Asthma; Chronic Disease; Dose-Response Relationship, Drug; Double-Blind Method; Fluticasone; Forced Expiratory Volume; Humans; Male; Middle Aged; Mometasone Furoate; Nebulizers and Vaporizers; Powders; Pregnadienediols; Pulmonary Ventilation; Sleep Initiation and Maintenance Disorders

Topics: Adolescent; Adult; Anti-Inflammatory Agents; Child; Child, Preschool; Chronic Disease; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Pregnadienediols; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal; Treatment Outcome

Mometasone furoate [9a, 21-dichloro-llb, 17dihydroxy-16a-methyl-pregna-14-dione-3, 20-dione-17-(2furoate)] is a synthetic, 17-heterocyclic corticosteroid which has been shown to be highly effective as an anti-inflammatory agent which is approximately half as potent is suppressing hypothalamic-pituitary-adrenal (HPA) axis function as betamethasone valerate.. The present open, randomised, third party blinded, left-right sided study was designed to compare the therapeutic efficacy of mometasone furoate cream 0.1% with clobetasol propionate cream 0.05% applied twice daily in chronic eczema following a 3-week course of therapy.. Sixty consecutive patients with moderate to severe bilateral chronic eczema on the limbs were recruited into the study. The mean scores of various signs/symptoms including erythema, induration, crusting, scaling, excoriation and pruritus before and after 3 weeks treatment with mometasone furoate (MF) and clobetasol propionate (CP) cream, were compared. The baseline scores for MF and CP treated sites were almost identical. There was significant decrease in the mean scores of all signs/symptoms after 3 weeks treatment with MF and CP. There was also a significant difference in the mean scores between MF and CP treated sites after 3 weeks of treatment. The mean scores were significantly lower for CP treated sites than MF treated sites. More CP treated sites achieved "cleared" or "marked improvement" response than MF treated sites. There were more "excellent" or "good" grades on CP treated sites than MF treated sites at the end of 3 weeks of treatment. None of the patients showed any side-effects after 4 weeks of treatment.. Overall, 53% of patients considered the MF treated sites to be good or excellent vs 88% for CP treated sites.

Topics: Administration, Topical; Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents; Chronic Disease; Clobetasol; Drug Administration Schedule; Eczema; Female; Glucocorticoids; Humans; Male; Middle Aged; Mometasone Furoate; Pregnadienediols; Treatment Outcome

Chronic rhinosinusitis (CRS) is a complex inflammatory disease of the sinonasal tract. To understand this disease entity and develop targeted treatments, a reproducible animal model is paramount.. To optimize a murine model of eosinophilic CRS by establishing benchmark histological markers and validate its fidelity in evaluating intranasal treatments.. Forty-five Balb/c mice were included in the 7-week protocol. Experimental animals (n = 20) were induced a CRS disease state upon receiving intraperitoneal sensitization with ovalbumin (OVA), followed by intranasal OVA with Aspergillus oryzae protease. Analysis of complete blood count with differential, peripheral blood smear, and histological markers from the nasal cavity mucosa were performed. CRS mice were additionally treated with intranasal saline (n = 5) or mometasone (n = 10) and compared with control groups of untreated CRS (n = 5) and healthy (n = 5) mice after week 7.. Histological analysis of experimental animal nasal mucosa revealed significantly higher levels of eosinophilic tissue infiltration/degranulation, hyaline droplets, Charcot-Leyden crystals, and respiratory epithelial thickness compared to healthy controls. Treatment with mometasone significantly reversed the histopathological changes observed in CRS mice.. This murine model induced substantial local eosinophilic inflammation within sinonasal mucosa, that was reversible with mometasone. This model may be used to evaluate the efficacy of therapeutics designed to target CRS.

Topics: Animals; Chronic Disease; Disease Models, Animal; Eosinophilia; Mice; Mometasone Furoate; Nasal Mucosa; Nasal Polyps; Rhinitis; Sinusitis

Medically refractory chronic rhinosinusitis (CRS) is often treated with functional endoscopic sinus surgery (FESS) and high-volume steroid nasal irrigation. While budesonide is the most common steroid irrigation for this indication, mometasone has a superior pharmacokinetic profile, which may allow dose escalation. The safety and efficacy of mometasone at higher concentrations than previously used in treating CRS have not been explored.. Patients were recruited from a tertiary level clinic between June 2018 and December 2019. Inclusion criteria included adults (>18 years); CRS diagnosis; previous FESS; pre-treatment morning cortisol within normal range; minimum of twice daily high-volume sinonasal mometasone irrigations (total dose of 4 mg) for 12 weeks; and post-treatment morning cortisol measured within 2 weeks following the study period. Patients with potential for endogenous or exogenous disruption of the HPA axis were excluded.. 14 patients were enrolled in this prospective cohort study. In all but one patient, pre- and post-treatment morning cortisol levels were not significantly different and were within normal limits (6.7-25.4 μg/dL). Following an uninterrupted 12-week treatment course, no evidence of HPA axis suppression was found (P = 0.915). The single patient who was found to have a low (1.3 μg/dL) post-treatment morning serum cortisol level reportedly received an intraarticular steroid shot several days prior to the blood draw. She remained asymptomatic and her rechecked serum cortisol was within normal limits at 12.3 μg/dL.. High-volume 2 mg twice daily sinonasal mometasone irrigations did not cause HPA axis suppression in a representative sample of patients with refractory CRS post-FESS with normal baseline cortisol levels.

Topics: Adult; Chronic Disease; Female; Humans; Hydrocortisone; Hypothalamo-Hypophyseal System; Mometasone Furoate; Nasal Lavage; Pituitary-Adrenal System; Prospective Studies; Rhinitis; Sinusitis; Treatment Outcome

Topics: Chronic Disease; Endoscopy; Humans; Mometasone Furoate; Paranasal Sinuses; Rhinitis; Sinusitis; Treatment Outcome

Mometasone-eluting stents (MES) have demonstrated improvement in short-term endoscopic outcomes and reduce short- to medium-term rescue interventions. Their effect on the local inflammatory environment, longer-term patient-reported outcomes, and radiographic severity have not been studied.. Middle meatal mucus and validated measures of disease severity were collected before and 6 to 12 months after endoscopic surgery in 52 patients with chronic rhinosinusitis with nasal polyps (CRSwNPs). Operative findings, type 2 mediator concentrations, intraoperative variables, and disease severity measures were compared between those who did and those who did not receive intraoperative frontal MES.. A total of 52 patients with CRSwNPs were studied; 33 received frontal MES and were compared with 19 who did not. Pre-endoscopic sinus surgery (ESS) middle meatus (MM) interleukin (IL) 13 and eosinophil cationic protein (ECP) were higher in the stented group (p < 0.05), but pre-ESS clinical measures of disease severity were similar as were surgical extent and post-ESS medical management. Intraoperative eosinophilic mucin was more frequent in the stented group (58% vs 11%, p = 0.001). IL-5 (p < 0.05) and IL-13 (p < 0.001) decreased post-ESS in the stented group, but this was not observed in the nonstented group. Post-ESS IL-4 and IL-13 were higher in the nonstented vs stented group (p < 0.05 for both).. Although patients who received intraoperative frontal MES had significantly higher pre-ESS MM IL-13 and ECP, patients who received frontal MES had lower concentrations of IL-4 and IL-13 than those who did not at a median of 8 months post-ESS. However, these changes did not correspond to significantly different measures of symptomatic or radiographic disease severity.

Topics: Chronic Disease; Drug-Eluting Stents; Endoscopy; Frontal Sinus; Humans; Interleukin-13; Interleukin-4; Interleukin-5; Mometasone Furoate; Nasal Polyps; Rhinitis; Sinusitis

P-glycoprotein (P-gp) is a membrane efflux pump which is overexpressed in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and promotes Type 2 inflammation. Glucocorticoids (GC) are substrates of P-gp suggesting that overexpression may additionally contribute to GC resistance in CRSwNP. This study aims to determine whether P-gp inhibition using verapamil enhances mometasone retention and efficacy in nasal polyp explants.. IRB approved study in which organotypic polyp explants were exposed to mometasone (4.15 μg/mL) and verapa- mil (125 μg/mL) as mono and combination therapy. The effect of verapamil on mometasone tissue retention over time was deter- mined using HPLC. The effect of verapamil on mometasone anti-inflammatory function was determined using ELISA for secreted IL-5. Groups were compared using Kruskal-Wallis test.. P-gp expression strongly and significantly inversely correlated with mometasone retention 1hr after exposure, with a ne- arly 6-fold reduction in tissue retention between the lowest and highest P-gp expressing polyp explants. P-gp inhibition reversed this effect and significantly improved mometasone retention at 1hr relative to mometasone alone. The combination of mome- tasone and verapamil significantly reduced IL-5 secretion relative to vehicle control and outperformed either treatment alone.. Our study confirms that P-gp contributes to mometasone resistance. This P-gp mediated resistance was successfully reversed by addition of the P-gp inhibitor verapamil. Verapamil further significantly enhanced the anti-inflammatory effect of mometasone when given as a combination therapy.

Topics: ATP Binding Cassette Transporter, Subfamily B; ATP Binding Cassette Transporter, Subfamily B, Member 1; Chronic Disease; Humans; Mometasone Furoate; Nasal Polyps; Rhinitis; Sinusitis; Verapamil

Topics: Adult; Aged; Anti-Inflammatory Agents; Betacoronavirus; Budesonide; Chronic Disease; Coronavirus Infections; COVID-19; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Lavage; Pandemics; Pilot Projects; Pneumonia, Viral; Pregnanes; Retrospective Studies; Rhinitis; SARS-CoV-2; Sinusitis; Treatment Outcome

Topics: Absorbable Implants; Adult; Ambulatory Surgical Procedures; Anti-Inflammatory Agents; Chronic Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Paranasal Sinuses; Prosthesis Implantation; Randomized Controlled Trials as Topic; Recurrence; Rhinitis; Sinusitis; Treatment Outcome

Topics: Chronic Disease; Clinical Trials as Topic; Humans; Mometasone Furoate; Nasal Lavage; Off-Label Use; Rhinitis; Sinusitis; Steroids

There is currently conflicting level 1 evidence in the use of long-term antibiotics for chronic rhinosinusitis without nasal polyps. The primary aim of this feasibility study was to optimise future randomised trial design by assessing recruitment and retention of patients alongside providing preliminary data on symptomatic control.. Prospective, multicentre feasibility (cohort) study with all patients receiving macrolide therapy for 12 weeks and a further subsequent 12-week follow-up. Participants received a 12-week course of clarithromycin 250 mg alongside twice daily topical mometasone and nasal douching. Primary outcomes focused on recruitment, retention and compliance. Clinical and quality-of-life outcomes measures were also recorded.. Patients were prospectively recruited from six UK outpatient clinics.. Adult patients with chronic rhinosinusitis without nasal polyps and no prior endoscopic sinus surgery underwent baseline assessment and then follow-up at 3 and 6 months.. Six-month recruitment and retention data.. Over 13 months, 55 adults were recruited from five centres. Four patients declined participation. 75% of patients were retained within the study. Dropouts included one medication contraindication, three unable to tolerate medication and 10 not attending full follow-up. Sino Nasal Outcome Test-22 and endoscopic scores showed statistically significant improvement. No other clinical or quality-of-life assessment improvements were seen.. Retention and recruitment to a trial using long-term clarithromycin to treat chronic rhinosinusitis without nasal polyps is achievable and this data will support a future randomised controlled trial. The study provides vital insight into trial design, thus informing UK research networks and rhinology researchers internationally.

Topics: Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents; Anti-Inflammatory Agents; Chronic Disease; Clarithromycin; Drug Administration Schedule; Feasibility Studies; Female; Humans; Male; Medication Adherence; Middle Aged; Mometasone Furoate; Patient Selection; Prospective Studies; Rhinitis; Sinusitis; Therapeutic Irrigation; United Kingdom; Young Adult

Microbial biofilms have been implicated in the pathogenesis of chronic rhinosinusitis with nasal polyposis (CRSwNP). Intranasal application of corticosteroids and saline is a reliable option for their management. The aim of our study was to evaluate in vitro antibiofilm effects of corticosteroids and isotonic and hypertonic nasal saline in CRSwNP patients. The sinus mucosal specimens were harvested from the ethmoid cavity of 48 patients with CRSwNP and further subjected to hematoxylin-eosin staining and microbiology analysis. The biofilm-forming capacity of isolated bacterial strains was detected by microtiter-plate method and the effects of therapeutic doses of mometasone, fluticasone, isotonic and hypertonic saline on biofilm production were investigated. Bacterial strains were isolated in 42 (87.5%) patients: one organism in 34 (80.9%) and two organisms in 8 (19.1%). Staphylococcus epidermidis (34%) and Staphylococcus aureus (28%) were the most prevalent bacteria in biofilms of CRSwNP patients. Corticosteroids and saline solutions significantly reduced biofilm formation (p < 0.01 and p < 0.05, respectively) with better efficacy of fluticasone and isotonic nasal saline. Treatment with fluticasone, mometasone, isotonic and hypertonic nasal saline completely prevented biofilm production in 66, 50, 84 and 38% of bacterial strains, respectively. The most significant density reduction was observed in biofilm formed by Staphylococcus aureus, Pseudomonas aeruginosa and Streptococcus pneumoniae compared to other bacterial species (p < 0.01, p < 0.05, p < 0.05, respectively). The antibiofilm effects of corticosteroids and saline solutions also greatly depended on bacterial biomass (p < 0.05), with the most significant effect on high compared to small amount of formed biofilm. The topical steroids and nasal saline are shown to be potent antibiofilm agents in patients with CRSwNP. The effects of tested compounds depend on bacterial species and volume of formed biofilm.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Adult; Aged; Biofilms; Chronic Disease; Drug Therapy, Combination; Female; Fluticasone; Humans; In Vitro Techniques; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Prospective Studies; Pseudomonas aeruginosa; Rhinitis; Sinusitis; Sodium Chloride; Staphylococcus aureus; Staphylococcus epidermidis; Streptococcus pneumoniae

Topics: Anti-Inflammatory Agents; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Chronic Disease; Humans; Injections, Subcutaneous; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Rhinitis; Sinusitis

Available medical treatments for chronic rhinosinusitis (CRS) with nasal polyposis (CRSwNP) comprise systemic and topical therapies. Although topical corticosteroids are effective in the treatment of CRS, they are not completely devoid of adverse effects. Thus, care has to be taken when long-term treatments are prescribed. There is recent evidence that sodium hyaluronate (SH), the major component of many extracellular matrices, promotes tissue healing, including activation and moderation of the inflammatory responses, cell proliferation, migration, and angiogenesis.. The aim of the study was to evaluate clinical outcomes and quality of life in two groups of patients with CRSwNP treated with topical corticosteroids alone or in combination with 9 mg of high-molecular-weight SH.. The impact of treatments was determined by using nasal endoscopy and validated quality of life questionnaires (Short Form-36, 22-item Sino-Nasal Outcome Test, visual analog scale [VAS]). Eighty subjects who had CRS with grade IV nasal polyposis: 40 diagnosed with allergic rhinitis (AR) and 40 with non-allergic-eosinophilic rhinitis (NARES) based on skin-prick test and nasal cytology results, were divided in two groups. Group I comprised 40 subjects (20 AR and 20 NARES), who received mometasone furoate plus SH; group II comprised 40 subjects (20 AR and 20 NARES), who received mometasone furoate plus saline solution alone. All the patients were followed up for 3 months.. At baseline, no statistically significant differences were observed between the groups and the VAS score showed a moderate-to-severe degree of disease. After treatments, Lund and Kennedy, Short Form-36, 22-item Sino-Nasal Outcome Test, and VAS scores were statistically significant in both groups but slightly in favor of the group I and in the subjects with allergic CRSwNP.. Analysis of our data indicated that an SH supplement to standard corticosteroid seems to play an important role in improving the severity of symptoms, the endoscopic appearance, and discomfort associated with CRSwNP. This effect seems to be strongest in patients with allergic CRSwNP.

Topics: Administration, Topical; Adrenal Cortex Hormones; Adult; Chronic Disease; Endoscopy; Female; Humans; Hyaluronic Acid; Male; Middle Aged; Mometasone Furoate; Nasal Polyps; Quality of Life; Rhinitis; Sinusitis; Surveys and Questionnaires; Visual Analog Scale; Wound Healing

Propel and Propel Mini sinus implants are mometasone furoate-coated bioabsorbable stents used as an adjunct in the management of chronic rhinosinusitis after endoscopic sinus surgery. The original sinus implant was deployed in the ethmoid sinuses to provide medialization of the middle turbinate, decrease scarring and mucosal adhesions, limit polyp regrowth, and reduce mucosal inflammation. A structurally smaller version of the Propel, the Propel Mini, was developed and now has been approved for endoscopic placement in the frontal sinuses. Areas covered: This evaluation will focus on the technical details of the Propel mini, previous studies documenting Propel's success in the ethmoid sinuses, and the safety and efficacy of the Propel mini implants in frontal sinus surgery. Expert opinion: Devices such as the Propel and Propel Mini stents are the beginning of a trend towards medication-coated bioabsorbable implants that can be used for sinonasal disease to minimize complications or possible side effects of surgical treatment by an increase of topical drug delivery locally.

Topics: Absorbable Implants; Chronic Disease; Endoscopy; Frontal Sinus; Humans; Mometasone Furoate; Rhinitis; Sinusitis

Intranasal steroids are the first line of treatment for chronic rhinosinusitis. Although contamination of adjunctive devices (e.g. irrigation bottles) has been much investigated, little is known about nasal contamination of the metered-dose spray bottles used to deliver intranasal steroids, and the potential influence on disease chronicity.. Twenty-five prospectively recruited patients with stable chronic rhinosinusitis underwent microbiological analysis of their nasal vestibule and middle meatus and also of their steroid bottle tip and contents. Additionally, bottle tips were inoculated in vitro with Staphylococcus aureus and various sterilisation techniques tested.. For 18 of the 25 (72 per cent) patients, both nasal and bottle tip swabs grew either Staphylococcus aureus or coagulase-negative staphylococci. Staphylococcus aureus was cultured from 7 of the 25 (28 per cent) patients, and 5 of these 7 had concomitant bacterial growth from both nose and steroid bottle. Thus, the cross-contamination rate was 71 per cent for Staphylococcus aureus infected patients and 20 per cent overall. Sterilisation was effective with boiling water, ethanol wipes and microwaving, but not with cold water or dishwashing liquid.. Nasal steroid spray bottle tips can become contaminated with sinonasal cavity bacteria. Simple sterilisation methods can eliminate this contamination. Patient education on this matter should be emphasised.

Topics: Administration, Intranasal; Aged; Androstadienes; Anti-Inflammatory Agents; Chronic Disease; Equipment Contamination; Female; Fluticasone; Fomites; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Cavity; Nasal Sprays; Patient Education as Topic; Pregnadienediols; Prospective Studies; Rhinitis; Sinusitis; Staphylococcus aureus; Sterilization

Microbial biofilms have been implicated in the pathogenesis of chronic rhinosinusitis with nasal polyposis (CRSwNP). Intranasal application of corticosteroids (INCS) is a reliable option in the management of CRSwNP. INCS medication has been suspected to influence the presence and thickness of microbial biofilms and inflammatory cell patterns in CRSwNP. Two series of identical nasal polyps obtained from non-allergic patients with CRSwNP (n = 56), who underwent endoscopic sinus surgery (ESS), were processed to hematoxylin-eosin (H.E.) and Gram staining, respectively. Patients were recruited into three groups. Group A (n = 21) consisted of patients with continuous preoperative INCS treatment. In group B (n = 17), patients were never treated by INCS, while in group C (n = 18) INCS medication was stopped at least 6 months before ESS. Biofilm positivity varied from 76.4 to 88.8% in different subject groups. These values and average thickness of biofilms did not reach statistically significant levels (Mann-Whitney's U probe, p > 0.05) in different patient groups. In contrast, microscopic pattern and numbers of predominant inflammatory cell populations displayed obvious differences according to INCS treatment (Mann-Whitney's U probe, p < 0.001). According to these observations, INCS treatment does not affect the presence and thickness of microbial biofilms in CRSwNP. In contrast, it has significant effects on the pattern of inflammatory cells infiltrating the subepithelial layer, which might result in beneficially altered extracellular matrix production and cytokine release.

Topics: Administration, Intranasal; Adrenal Cortex Hormones; Adult; Aged; Biofilms; Case-Control Studies; Chronic Disease; Cytokines; Endoscopy; Eosinophils; Extracellular Matrix; Female; Gram-Positive Cocci; Humans; Image Interpretation, Computer-Assisted; Leukocyte Count; Male; Middle Aged; Mometasone Furoate; Nasal Mucosa; Nasal Polyps; Neutrophils; Pregnadienediols; Rhinitis; Sinusitis; Tomography, X-Ray Computed

This study aimed to evaluate the cost-effectiveness of a mometasone steroid-eluting sinus implant compared to a nonsteroid-eluting sinus implant following endoscopic sinus surgery (ESS) for chronic rhinosinusitis.. Economic evaluation using a decision tree model.. Academic and nonacademic otolaryngology practices.. Patients with refractory chronic rhinosinusitis undergoing ESS.. The economic perspective was the health care third party payer. Effectiveness and probability data were obtained from a single meta-analysis of 2 randomized, double-blind, controlled trials. Costs were obtained from the Centers for Medicare & Medicaid Services database and wholesale pharmaceutical pricing. Multiple sensitivity analyses were performed including a probabilistic sensitivity analysis. Comparative treatment groups were (1) placement of the mometasone steroid-eluting sinus implant following ESS and (2) placement of a nonsteroid-eluting implant following ESS. The primary outcome was cost per postoperative intervention avoided within 60 days after ESS.. The mean cost for the steroid-eluting and nonsteroid-eluting sinus implant strategies were $1,572.91 and $365.18, respectively. The steroid-eluting strategy incremental cost-effectiveness ratio was $5,489.68. The sensitivity analysis demonstrated a 74.3%, 87.2%, and 90.5% certainty that the steroid-eluting implant strategy is cost-effective at willingness-to-pay thresholds of $10,000, $25,000, and $50,000, respectively.. Results from this economic evaluation suggest that placement of a mometasone steroid-eluting sinus implant into the ethmoid cavity following ESS for refractory chronic rhinosinusitis is a cost-effective intervention for preventing a postoperative intervention within 60 days after surgery.

Topics: Anti-Inflammatory Agents; Chronic Disease; Cost-Benefit Analysis; Decision Trees; Drug-Eluting Stents; Endoscopy; Female; Humans; Male; Mometasone Furoate; Rhinitis; Sinusitis; Treatment Outcome; United States

The objective of the present study was to improve the effectiveness of medicamental therapy of exudative otitis media in the children with recurrent and chronic adenoiditis. It was shown that the use of fluifort (carbocysteine lysine salt) for the treatment of exudative otitis media in the children presenting with chronic adenoiditis is a more effective approach in comparison with the expectant management. It is concluded that the application of carbocysteine lysine salt in combination with the mometasone furoate nasal spray ensures the rapid elimination of the symptoms of adenoiditis and significantly accelerates the resolution of exudative otitis media compared with the monotherapeutic treatment.. Цель исследования - повышение эффективности медикаментозной терапии экссудативного среднего отита у детей с рецидивирующими и хроническими аденоидитами. Показано, что использование карбоцистеина лизиновой соли (флуифорт) в терапии экссудативного среднего отита у детей с рецидивирующим и хроническим аденоидитом является более эффективным методом лечения по сравнению с выжидательной тактикой. Применение карбоцистеина лизиновой соли в комбинации с назальным спреем мометазона фуроата позволяет достичь быстрого купирования симптомов аденоидита и значительно ускоряет разрешение экссудативного среднего отита по сравнению с монотерапевтическим подходом.

Topics: Adenoids; Anti-Infective Agents, Local; Anti-Inflammatory Agents; Carbocysteine; Child; Child, Preschool; Chronic Disease; Comorbidity; Drug Therapy, Combination; Humans; Mometasone Furoate; Nasopharyngitis; Otitis Media with Effusion; Pregnadienediols; Treatment Outcome

Chronic rhinitis and adenoid hypertrophy are the main causes of nasal obstruction in children and proper treatment of these factors seem essential for controlling nasal obstructive symptoms. This study aims to evaluate the effects of topical mometasone treatment on symptoms and size of adenoid tissue in children with complaints of nasal obstruction and to compare this approach to continuous nasal saline douching plus environmental control alone.. Fifty-one children with nasal obstructive complaints were submitted to a semi-structured clinical questionnaire on nasal symptoms, prick test and nasoendoscopy. Nasoendoscopic images were digitalized, and both adenoid and nasopharyngeal areas were measured in pixels. The relation adenoid/nasopharyngeal area was calculated. Patients were subsequently re-evaluated in two different periods: following 40 days of treatment with nasal douching and environmental prophylaxis alone; and after an subsequent 40 day-period, when topical mometasone furoate (total dose: 100μg/day) was superposed.. Nasal symptoms and snoring significantly improved after nasal douching, and an additional gain was observed when mometasone furoate was included to treatment. Saline douching did not influence the adenoid area, whereas a significant reduction on adenoid tonsil was observed after 40 days of mometasone treatment (P<0.0001).. Nasal saline douching significantly improved nasal symptoms without interfering in adenoid dimension. In contrast, mometasone furoate significantly reduced adenoid tissue, and led to a supplementary improvement of nasal symptoms.

Topics: Adenoids; Administration, Intranasal; Anti-Inflammatory Agents; Child; Child, Preschool; Chronic Disease; Cohort Studies; Environment; Female; Follow-Up Studies; Humans; Hypertrophy; Male; Mometasone Furoate; Nasal Obstruction; Observer Variation; Pregnadienediols; Rhinitis; Risk Assessment; Sodium Chloride; Statistics, Nonparametric; Therapeutic Irrigation; Treatment Outcome

To assess the effect of in-office intranasal application of mometasone furoate (MF) gel in reducing sinonasal mucosal inflammation in patients who have undergone endoscopic sinus surgery (ESS) for chronic rhinosinusitis.. Retrospective review.. Symptomatic post-ESS patients were evaluated with nasal endoscopy. Sinus mucosa was graded as normal, edematous, polypoid, or with frank polyps (scored as 0, 1, 2, or 3, respectively), and the presence or absence of eosinophilic mucin was noted. MF gel was then applied under endoscopic visualization to sinus mucosa demonstrating signs of inflammation. Patients returned to the clinic for three follow-up visits for nasal endoscopy and mucosal evaluation and, if indicated, retreatment with MF gel.. Sixteen patients were treated with hydrophilic MF gel. The volume and concentrations applied were 2 to 10 cc of 1200 μg/5 cc MF gel (ASL Pharmacy, Camarillo, CA). At the initial visit, the average mucosal score was 2.19 ± 0.16. At follow-up visits 1 and 2, the average mucosal score was 1.44 ± 0.25 (p  =  .01) and 1.38 ± 0.28 (p  =  .03), respectively. There was an observed overall decrease in systemic steroid use.. In-office endoscopic sinonasal application of MF gel is a useful adjunct to treat mucosal inflammation in postoperative patients with chronic rhinosinusitis. It may help reduce the need for systemic as well as topical steroid therapy.

Topics: Administration, Intranasal; Anti-Allergic Agents; Chronic Disease; Endoscopy; Female; Gels; Humans; Male; Middle Aged; Mometasone Furoate; Postoperative Complications; Pregnadienediols; Retrospective Studies; Rhinitis; Sinusitis; Treatment Outcome

Topics: Adolescent; Adult; Aged; Anti-Allergic Agents; Anti-Inflammatory Agents; Chronic Disease; Debridement; Endoscopy; Female; Follow-Up Studies; Humans; Male; Middle Aged; Mometasone Furoate; Nasal Lavage; Pregnadienediols; Rhinitis; Sinusitis; Treatment Outcome; Young Adult

Topics: Administration, Cutaneous; Adolescent; Adrenal Cortex Hormones; Adult; Aged; Aged, 80 and over; Chronic Disease; Humans; Middle Aged; Mometasone Furoate; Pregnadienediols; Skin Diseases; Treatment Outcome

Topics: Acute Disease; Bacterial Infections; Ceftibuten; Cephalosporins; Chronic Disease; Clavulanic Acid; Drug Resistance, Multiple; Humans; Mometasone Furoate; Penicillanic Acid; Pregnadienediols; Sinusitis; Treatment Outcome

Topics: Administration, Topical; Anti-Inflammatory Agents; Chronic Disease; Glucocorticoids; Humans; Mometasone Furoate; Nasal Polyps; Nose Neoplasms; Pregnadienediols; Sinusitis; Snoring