Efficacy, safety, and optimal dose selection of beclomethasone dipropionate nasal aerosol for seasonal allergic rhinitis in adolescents and adults. (October 2013)

• Record Type: Journal Article
• Authors: Raphael, Gordon D.; Berger, William E.; Prenner, Bruce M.; Finn, Albert F.; Kelley, Leith; Tantry, Sudeesh K.
• Is Part Of: Current medical research and opinion. Volume 29:Number 10(2013:Oct.)
• Page Start: 1329
• Page End: 1340
• Publication Date: 2013-10
• Subjects: Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1185/03007995.2013.821055
• Languages: English
• ISSNs: 0300-7995

Abstract

<abstract> <title>Abstract</title> <sec id="ss1"> <title>Objective:</title> <p>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).</p> </sec> <sec id="ss2"> <title>Methods:</title> <p>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 <sc>a.m.</sc> and <sc>p.m.</sc> 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.</p> </sec> <sec id="ss3"> <title>Results:</title> <p>Significant improvements were seen in average <sc>a.m.</sc> and <sc>p.m</sc>. rTNSS (least squares [LS] mean treatment difference, −0.63; 95% CI: −1.13, −0.13; <italic>p</italic> = 0.013) as well as in average <sc>a.m.</sc> and <sc>p.m.</sc> instantaneous TNSS (iTNSS; LS mean treatment difference, −0.60; 95% CI: −1.09, −0.11; <italic>p</italic> = 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.</p> </sec> <sec id="ss4"> <title>Conclusions:</title> <p>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.</p> </sec> <sec id="ss5"> <title>Trial registration NCT:</title> <p>#NCT00854360.</p> </sec> </abstract>