Azelastine Nasal Spray (0.15%) Once Daily in Treating Nasal and Ocular Symptoms of Seasonal Allergic Rhinitis

2010 ◽  
Vol 125 (2) ◽  
pp. AB176 ◽  
Author(s):  
F. Hampel ◽  
P. Ratner ◽  
W. Wheeler ◽  
H. Sacks
1997 ◽  
Vol 11 (4) ◽  
pp. 323-330 ◽  
Author(s):  
Martin A. Stern ◽  
Ronald Dahl ◽  
Lars P. Nielsen ◽  
Bente Pedersen ◽  
Camilla Schrewelius

The efficacy of aqueous suspensions of budesonide nasal spray and fluticasone propionate nasal spray, in the treatment of seasonal allergic rhinitis, was compared in a large, placebo-controlled, two-center study. A 1-week baseline period was followed by a 4- to 6-week treatment period during which 635 adult patients, aged 18–72 years, were randomized to receive either placebo, budesonide 128 μg, or 256 μg once daily, or fluticasone propionate, 200 μg once daily. Nasal and eye symptoms, overall treatment efficacy and safety assessments were made during the study period. Combined, as well as individual, nasal symptoms were significantly improved in all three active treatment groups compared with placebo therapy. Treatment with 256 μg/day of budesonide was found to be significantly more effective in reducing the sneezing score compared with 200 μg/day of fluticasone propionate. Analysis of symptom scores on days when the pollen count was greater than 10 grains/m3 revealed 256 μg/day of budesonide therapy to be significantly more effective in reducing combined symptom scores as well as the individual scores for sneezing and runny nose, compared with 200 μg/day fluticasone propionate. The higher dose of budesonide (256 μg/day) was also more effective than the lower dose (128 μg/day) in reducing sneezing scores and statistical significance was almost reached for the reduction in combined symptom and runny nose scores. Substantial or total control of symptoms was achieved by 31.4%, 85.3%, 88.4%, and 81.9% of patients receiving placebo, 128 μg/day of budesonide, 256 μg/day of budesonide, and 200 μg/day of fluticasone propionate, respectively. The incidence of adverse events was low in all treatment groups. In conclusion, both budesonide and fluticasone propionate treatments were effective and well-tolerated in the treatment of seasonal allergic rhinitis. However, 256 μg/day of budesonide tended to be more effective than 200 μg/day of fluticasone propionate and 128 μg/day of budesonide, especially when patients were exposed to a higher pollen load.


2015 ◽  
Vol 135 (2) ◽  
pp. AB271
Author(s):  
Paul H. Ratner ◽  
Julius H. Van Bavel ◽  
Dale E. Mohar ◽  
Robert L. Jacobs ◽  
Frank Hampel ◽  
...  

2019 ◽  
Vol 40 (3) ◽  
pp. 173-179 ◽  
Author(s):  
Eduardo Urdaneta ◽  
Kaan Tunceli ◽  
Davis Gates

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.


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