Fall Epidemic Viral Pediatric Study

Summary

Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma exacerbation(s). Approximately 40 clinical sites in the United States will randomize 316 subjects. Eligible subjects will be randomly assigned to one of two double-blind treatments using a 1:1 randomization. Subjects will be identified for their eligibility for enrolment starting in April 2010. Eligible subjects will be invited to return for randomization into the study in August 2010. This exploratory study is being conducted to assess whether treatment with ADVAIR™ DISKUS™ 100/50 mcg is more effective at reducing the risk of exacerbation and the asthma impairment associated with viral respiratory tract infections during the fall season when compared to treatment with FLOVENT™ DISKUS™ 100 mcg.

Timeline

Start

2010-08

Primary completion

2010-12

Completion

2010-12

Publications

• Prazma CM, Gern JE, Weinstein SF, Prillaman BA, Stempel DA. The association between seasonal asthma exacerbations and viral respiratory infections in a pediatric population receiving inhaled corticosteroid therapy with or without long-acting beta-adrenoceptor agonist: a randomized study. Respir Med. 2015 Oct;109(10):1280-6. doi: 10.1016/j.rmed.2015.06.010. Epub 2015 Jun 24.

Drugs

Indications