Asthma Clinical Trial
Official title:
A Randomized, Parallel Group, Placebo-controlled, Multicenter Phase 3 Study With a PK Sub-group Study With Beclomethasone HFA at 400 μg and 800 μg Daily Doses Compared to Placebo and QVAR in Persistent Asthma.
Approximately 480 (120 per group) would need to complete the 6 weeks of treatments.
This is four arm study. Approximately 480 (120 per group) would need to complete the 6 weeks
of treatments.
In order to achieve that number of subjects, approximately 700 subjects will be screened
randomized into the study.
A screening visit (Visit 1) will be inclusive of at least the 2-week (14 days) placebo Run-in
Period during which asthma subjects will wash out their daily inhaled corticosteroid and
other medications and assessed for compliance. Study treatment period will be for a duration
of 6 weeks with visits: Visit 2 - Baseline Day 1; Visit 3 Day 21 (± 2 days) and Visit 4 Day
42 (± 2 days). Rescue Therapy: Short-acting beta agonists, Albuterol 90 μg/actuation
;
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