This article is more than 5 years old. Information may no longer be current.

Beclomethasone dipropionate superior to placebo in perennial allergic rhinitis in children

Safety and efficacy data from a recent study demonstrated superiority of non-aqueous beclomethasone dipropionate nasal aerosol compared with placebo for the treatment of perennial allergic rhinitis in children.

“This study clearly showed that once-daily treatment with [beclomethasone dipropionate (BDP)] nasal aerosol at a dose of 80 µg was well tolerated and provided significant and clinically meaningful improvement in the nasal symptoms of [perennial allergic rhinitis (PAR)] in a pediatric population 4 to 11 years of age,” William E. Berger, MD, founder of Allergy and Asthma Associates of Southern California, and colleagues wrote.

Berger and colleagues conducted a randomized, double blind, placebo-controlled, parallel-group, phase 3 trial of 547 children aged 4 to 11 years to test the efficacy and safety of BDP nasal aerosol spray in children with PAR.

Patients either received 80 µg of BDP for 12 weeks (n = 362) or a placebo (n = 185) once daily in the morning. The patients completed allergic rhinitis assessments twice daily during the treatment period.

Researchers noted improvements in the average morning and evening reflective total nasal symptom score with the once-daily treatment of BDP than with placebo during the first 6 weeks of treatment in children aged 6 to 11 years (n = 449) (P = .002).

For children aged 4 to 11 years (n = 542), the researchers noted improvements in the average reflective total nasal symptom score as being greater in patients treated with BDP than those treated with placebo during the first 6 weeks as well (P = .002).

Nasal congestion (P = .017) and nasal itching (P = .031) greatly improved in children aged 4 to 11 years receiving BDP when compared with placebo.

Thirty-seven percent of patients receiving BDP reported experiencing adverse events while 34% receiving placebo reported experiencing adverse events.

“These findings support the safety and efficacy of BDP nasal aerosol for the continuous and sustained management of allergic rhinitis in a pediatric population 4 to 11 years of age,” the researchers wrote. – by Ryan McDonald

Disclosure: Berger reports receiving consultation, speaking and research fees from Alcorn, Allergan, Genentech, Mede, Mylan and Teva. Berger also reports research funding from Anacor, Circassia and Janssen. Please see the full study for a list of all other authors’ relevant financial disclosures.