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.
Phase:
Phase 4
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Fluticasone Fluticasone Propionate, Salmeterol Xinafoate Drug Combination Fluticasone-Salmeterol Drug Combination Salmeterol Xinafoate Xhance