A subgroup analysis in hispanic patients with allergic rhinitis of fluticasone propionate aqueous nasal spray for sinus pain and pressure caused by nasal congestion*1

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.

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A Comparison of Aqueous Suspensions of Budesonide Nasal Spray (128 μg and 256 μg Once Daily) and Fluticasone Propionate Nasal Spray (200 μg Once Daily) in the Treatment of Adult Patients with Seasonal Allergic Rhinitis

American Journal of Rhinology ◽

10.2500/105065897781446658 ◽

1997 ◽

Vol 11 (4) ◽

pp. 323-330 ◽

Cited By ~ 21

Author(s):

Martin A. Stern ◽

Ronald Dahl ◽

Lars P. Nielsen ◽

Bente Pedersen ◽

Camilla Schrewelius

Keyword(s):

Allergic Rhinitis ◽

Fluticasone Propionate ◽

Nasal Spray ◽

Seasonal Allergic Rhinitis ◽

Adult Patients ◽

Once Daily ◽

Treatment Groups ◽

Runny Nose ◽

Aqueous Suspensions ◽

Symptom Scores

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.

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