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Abstract
Objective:
Some patients with allergic rhinitis (AR) may prefer nonaqueous intranasal corticosteroid aerosols because of unwanted attributes of aqueous formulations. The mandatory removal of chlorofluorocarbon-propelled nonaqueous aerosols from the market limited available treatment options. To fulfill this unmet need, a nonaqueous, hydrofluoroalkane-propelled beclomethasone dipropionate (BDP) nasal aerosol was developed and approved for treatment of AR nasal symptoms. As part of the development program, this dose-ranging study evaluated three doses of BDP nasal aerosol to determine the optimally safe and effective dose for adolescent and adult patients (≥12 years old) with seasonal AR (SAR).
Methods:
After a 7 to 21 day placebo run-in period, eligible patients with SAR were randomly assigned to once-daily BDP nasal aerosol 80 µg, 160 µg, 320 µg, or placebo. The primary endpoint was the change from baseline in average a.m. and p.m. patient-reported reflective total nasal symptom scores (rTNSS) over 2 weeks. Safety and tolerability were also assessed. A potential study limitation could be lack of objective assessment of AR symptoms.
Results:
Significant improvements were seen in average a.m. and p.m. rTNSS (least squares [LS] mean treatment difference, −0.63; 95% CI: −1.13, −0.13; p = 0.013) as well as in average a.m. and p.m. instantaneous TNSS (iTNSS; LS mean treatment difference, −0.60; 95% CI: −1.09, −0.11; p = 0.016) with BDP nasal aerosol 320 µg/day compared with placebo. Although there were numerical improvements from baseline in patient-reported rTNSS and iTNSS with BDP nasal aerosol 80 µg and 160 µg, these doses did not achieve statistical significance compared with placebo. BDP nonaqueous nasal aerosol was well tolerated at all doses tested, with a safety profile comparable to that of placebo.
Conclusions:
These data indicate that 320 µg/day of BDP nasal aerosol is the optimally safe and effective dose for the treatment of SAR in adolescent and adult patients.
Trial registration NCT:
#NCT00854360.
Transparency
Declaration of funding
This work was funded by Teva Branded Pharmaceutical Products R & D Inc.
Declaration of financial/other relationships
G.D.R.: grant/research from Teva, GlaxoSmithKline, Sunovion. W.E.B.: grant/research from Alcon, Meda; consultant/advisor to Meda, AstraZeneca, Alcon, Novartis, Teva, and Allergan; speakers bureau for Alcon, AstraZeneca, Allergan, Meda; owner, Allergy and Asthma Associates. B.M.P.: grant/research: Array Biopharma, Genentech, Meda, Medimmune, Merck, Novartis, Rigel, Shionogi, Sunovion, Teva; consultant/advisor: Allergan, Astellas, Bausch and Lomb, Sunovion, Teva; speakers bureau: Genentech, Merck, Mylan, Sunovion, Teva. A.F.F.: grant/research, consultant/advisor and/or speakers bureau: Amphastar, Astellas, AstraZeneca, Boehringer Ingelheim, Chiltern, Forest, GlaxoSmithKline, Genentech, KaloBios, Medimmune, Merck, Novartis, Perrigo, Quintiles, Rigel, Sepracor, Shionogi, Sunovion, Teva, UBC/Amgen, Vectura. L.K. and S.K.T. are employees and stockholders of Teva.
CMRO peer reviewers on this manuscript have received honoraria for their review work, but have no other financial relationships to disclose.
Acknowledgments
The authors thank the study team and investigators for their valuable contribution in conducting this study and acknowledge Yu Ding (Teva Pharmaceuticals, Frazer, Pennsylvania) for statistical review of the manuscript. The authors also acknowledge the technical and editorial support provided by ApotheCom (Yardley, Pennsylvania).
Notes
*Beconase and Beconase AQ are registered trademarks of GlaxoSmithKline, Research Triangle Park, NC, USA
†Vancenase AQ and Vancenase Pockethaler were registered trademarks of Schering Plough, a company now owned by Merck, Whitehouse Station, NJ, USA