title: Efficacy and safety of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with seasonal allergic rhinitis.
abstract: An aerosol formulation may be preferred by some allergic rhinitis (AR) patients, to avoid the "wet feeling" and nasal runoff associated with aqueous nasal corticosteroid sprays. Beclomethasone dipropionate (BDP) hydrofluoroalkane nasal aerosol is a recently developed, nonaqueous,  nonchlorofluorocarbon formulation of BDP for the treatment of AR. This study was designed to evaluate the efficacy, safety, and quality-of-life benefits of BDP nasal aerosol in subjects with seasonal AR (SAR). Eligible subjects (≥12 years of age) enrolled in this 2-week study were randomized  to either BDP nasal aerosol at 320 μg/day (n = 169) or placebo (n = 171). Efficacy assessments included reflective and instantaneous total nasal symptom scores (rTNSS and iTNSS, respectively), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, reflective and instantaneous total  ocular symptom scores (rTOSS and iTOSS, respectively), and physician-assessed total nasal symptom score (PNSS). Safety and tolerability were also assessed. Subjects receiving BDP nasal aerosol showed a significantly greater improvement from baseline in average A.M. and P.M. rTNSS versus placebo  (treatment difference, -0.91; 95% confidence interval, -1.3, -0.5; p < 0.001) over 2 weeks of treatment. Greater improvements in rTNSS with BDP nasal aerosol compared with placebo were evident by day 2 and were maintained throughout the treatment period. Similarly, significant  improvements were seen with BDP nasal aerosol in iTNSS (p < 0.001) and RQLQ score (p = 0.005) compared with placebo. Treatment with BDP nasal aerosol also resulted in greater improvements in rTOSS (p = 0.002), iTOSS (p = 0.003), and PNSS (p < 0.001) relative to placebo. BDP nasal aerosol  was well tolerated and the overall safety profile was similar to placebo. Results from this clinical study indicated that BDP nasal aerosol provided significant AR symptom relief and was well tolerated in patients with SAR with an overall safety profile similar to placebo. Clinicaltrials.gov identifier: NCT01024608.
authors.affiliation: Isis Clinical Research, LLC, Austin, TX 78731, USA. jvanbavel@aol.com
authors.forename: Julius H
authors.initials: JH
authors.lastname: van Bavel
authors.forename: Paul H
authors.initials: PH
authors.lastname: Ratner
authors.forename: Niran J
authors.initials: NJ
authors.lastname: Amar
authors.forename: Frank C
authors.initials: FC
authors.lastname: Hampel
authors.forename: Amy
authors.initials: A
authors.lastname: Melchior
authors.forename: Stephanie A
authors.initials: SA
authors.lastname: Dunbar
authors.forename: Paul M
authors.initials: PM
authors.lastname: Dorinsky
authors.forename: Sudeesh K
authors.initials: SK
authors.lastname: Tantry
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000336:Aerosols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D001507:Beclomethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000336:Aerosols; D018926:Anti-Allergic Agents; D001507:Beclomethasone