Effect of mometasone furoate nasal spray on moderate-to-severe nasal congestion in seasonal allergic rhinitis: A responder analysis

2019 ◽  
Vol 40 (3) ◽  
pp. 173-179 ◽  
Author(s):  
Eduardo Urdaneta ◽  
Kaan Tunceli ◽  
Davis Gates
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Seasonal Allergic Rhinitis ◽  
Nasal Congestion ◽  
Mometasone Furoate ◽  
Double Blind ◽  
Positive Skin ◽  
Once Daily ◽  
Responder Analysis ◽  
End Point

Background: Nasal congestion is consistently identified as the most bothersome symptom of seasonal allergic rhinitis (SAR), and, in guidelines, intranasal corticosteroids are the preferred treatment for nasal congestion. Objective: The aim of this post hoc cumulative responder analysis was to examine the nasal congestion response in detail by depicting the level of response obtained in two double-blind, placebo controlled studies of mometasone furoate nasal spray (MFNS) therapy for SAR, conducted from August to October 2008 at U.S. sites, in which nasal congestion was prespecified as the primary end point. Methods: Patients ≥12 years of age with a ≥2-year SAR history, positive skin test result, and moderate or severe nasal congestion were randomly assigned to once-daily treatment in the morning with MFNS or placebo for 15 days. The primary end point was the change from baseline in morning and evening reflective nasal congestion scores averaged over days 1‐15. Treatment response, which ranged from >0% to >90% improvement, was evaluated at 10% intervals; >30% and >50% improvements were further evaluated by using the Mietinnen-Nurminen method weighted by study to test the differences of proportions. The Breslow-Day equal odds ratios test was used to justify pooling. Results: Of the 344 and 340 patients in the MFNS and placebo groups, respectively, the proportions of patients who experienced a >30% response in nasal congestion, averaged over 15 days, were 37% versus 19% in the MFNS and placebo groups, respectively (p < 0.001). Those who experienced a >50% response were 13% and 7%, respectively (p = 0.003). Among the patients treated with MFNS, the mean response was greater during the second versus the first week of treatment. There was no difference between responses in the morning versus evening or for patients with moderate versus severe nasal congestion at baseline. Conclusion: MFNS is effective in relieving moderate-to-severe nasal congestion in patients with SAR. The response to MFNS is maintained with once-daily administration and improves with continuous use over 2 weeks.

Fluticasone Propionate Aqueous Nasal Spray Is Safe and Effective for Children With Seasonal Allergic Rhinitis

PEDIATRICS ◽  
1993 ◽  
Vol 92 (4) ◽  
pp. 594-599
Author(s):  
Jay Grossman ◽  
Charles Banov ◽  
Edwin A. Bronsky ◽  
Robert A. Nathan ◽  
David Pearlman ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Fluticasone Propionate ◽  
Nasal Spray ◽  
Seasonal Allergic Rhinitis ◽  
Test Reaction ◽  
Double Blind ◽  
Positive Skin ◽  
Study Objective ◽  
Once Daily ◽  
Nasal Symptoms

Introduction. Fluticasone propionate aqueous nasal spray, a new topical corticosteroid preparation, is effective when given as 200 µg once daily in patients (&gt; 12 years of age) with seasonal allergic rhinitis. Study objective. To evaluate the efficacy and safety of fluticasone propionate aqueous nasal spray in children aged 4 to 11 years with seasonal allergic rhinitis. Study design. Multicenter, randomized, double-blind, placebo-controlled, parallel-group. Patients. Two hundred fifty children aged 4 to 11 years with moderate-to-severe nasal symptoms, a positive skin test reaction to a late-summer or autumn allergen, a history of seasonal allergic rhinitis, and documentation of an unsatisfactory response to conventional treatment. Interventions. Children were randomly assigned to receive fluticasone propionate, either 100 µg or 200 µg, or placebo, given by intranasal spray once daily in the morning for 14 days. Measurements and results. Severity of nasal symptoms (obstruction, rhinorrhea, itching, and sneezing) was recorded on visual analog scales by investigators at weekly visits and by patients (or adult guardian) daily in the evening. According to investigator and patient ratings, both fluticasone propionate 100 µg/d and 200 µg/d lowered total nasal symptom scores when compared with placebo. Both dosages of fluticasone propionate were more effective than placebo on the basis of investigatorrated overall clinical evaluation of efficacy at the end of treatment, with significant improvement (as opposed to moderate or mild improvement, no change or worsening) noted in 21% to 29% of the active-treatment groups vs 9% in the placebo group. There were no significant differences between the two fluticasone propionate dosages in any efficacy measurement. Morning plasma cortisol concentrations and frequency of drug-related adverse events were similar in the fluticasone propionate and placebo groups. Conclusion. In children as young as 4 years, 100 µg of fluticasone propionate aqueous nasal spray given once daily is as effective as 200 µg given once daily, the usual adult dose for the treatment of seasonal allergic rhinitis. Both fluticasone propionate dosages were well tolerated and neither dosage appears to interfere with the hypothalamic-pituitary-adrenal axis in children.

Double-Blind, Placebo-Controlled Trial of Reformulated Azelastine Nasal Spray in Patients with Seasonal Allergic Rhinitis

2009 ◽  
Vol 23 (5) ◽  
pp. 512-517 ◽  
Author(s):  
Jonathan A. Bernstein ◽  
Bruce Prenner ◽  
Berrylin J. Ferguson ◽  
Jay Portnoy ◽  
William J. Wheeler ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Dose Response ◽  
Seasonal Allergic Rhinitis ◽  
Nasal Congestion ◽  
Controlled Trial ◽  
Taste Masking ◽  
Comparable Efficacy ◽  
Original Formulation ◽  
Double Blind

Background Azelastine nasal spray is a topical antihistamine with a distinctive taste that may be objectionable to some patients. The primary objectives of this clinical trial were (1) to determine if a reformulated azelastine nasal spray (Astepro) with sucralose as a taste-masking agent provides comparable efficacy to the original formulation (Astelin) and (2) to evaluate dose–response relationships between groups. Methods Eight hundred thirty-five patients with seasonal allergic rhinitis were randomized to six treatment groups: (1) original azelastine nasal spray, 1 spray/nostril b.i.d.; (2) reformulated azelastine, 1 spray/nostril b.i.d.; (3) placebo, 1 spray/nostril b.i.d.; (4) original azelastine nasal spray, 2 sprays/nostril b.i.d., (5) reformulated, 2 sprays/nostril b.i.d.; and (6) placebo, 2 sprays/nostril b.i.d. The primary efficacy variable was the change from baseline to day 14 in total nasal symptom score (TNSS) consisting of runny nose, sneezing, itchy nose, and nasal congestion. Results Original azelastine nasal spray and the reformulated spray produced comparable improvements in the TNSS at both dosages. There was a dose-related difference in TNSS comparing the 1- and 2-spray dosages. The percentage changes from baseline in the TNSS in the 2-sprays/nostril dosage groups were 27.9% (p < 0.001) with the reformulated nasal spray, 23.5% (p < 0.01) with the original formulation, and 15.4% with placebo. The incidence of bitter taste was 7% with the reformulated spray and 8% with the original at the 2-sprays/nostril dosage. Conclusion The results of this study showed efficacy both with original azelastine nasal spray and with the reformulated nasal spray and a clear dose–response difference between the 1- and 2-spray dosages.

Once- versus Twice-Daily Fluticasone Propionate Aqueous Nasal Spray for Seasonal Allergic Rhinitis

1993 ◽  
Vol 7 (2) ◽  
pp. 77-83 ◽  
Author(s):  
Robert J. Dockhorn ◽  
Barry R. Paull ◽  
Eli O. Meltzer ◽  
Andre van As ◽  
Suzanne Weakley ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Fluticasone Propionate ◽  
Nasal Spray ◽  
Seasonal Allergic Rhinitis ◽  
Dosage Regimen ◽  
Controlled Study ◽  
Double Blind ◽  
Once Daily ◽  
Normal Ranges ◽  
Daily Dosage Regimen

A new potent topical corticosteroid, fluticasone propionate aqueous nasal spray, has proved effective when administered twice daily for seasonal allergic rhinitis. The purpose of this study was to compare the efficacy and safety of a once-daily dosage with twice-daily administration of fluticasone propionate. A multicenter, double-blind, randomized, placebo-controlled study was conducted in adults with moderate to severe symptoms of allergic rhinitis during the autumn pollen season. Patients were treated for 4 weeks with fluticasone propionate aqueous nasal spray, 200 μg once daily or 100 μg twice daily or matching placebo. Fluticasone propionate administered once daily in the morning was as effective as the twice-daily dosage regimen, and both regimens were more effective than placebo. Nasal symptoms were improved by the second day of treatment and continued to improve throughout the study. Nasal eosinophils were reduced in more patients treated with either regimen of fluticasone propionate compared with placebo. Adverse events were similar in frequency and nature in all three groups. There was no evidence of hypothalamicpituitary-adrenal axis effects; mean morning plasma cortisol concentrations and response to cosyntropin stimulation remained within normal ranges and were similar across groups. We conclude that fluticasone propionate aqueous nasal spray administered once daily is safe and as effective as a twice-daily dosage regimen for treating seasonal allergic rhinitis.

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