Asthma Clinical Trial
Official title:
A Randomized, Parallel Group, Multicenter, Double -Blind, Double-dummy, Placebo-controlled Phase 3 Study With Beclomethasone Dipropionate HFA at 100 μg, 200 μg and 400 μg Daily Doses Compared to Placebo in Mild or Moderate Persistent Asthma
Approximately 480 (120 per group) would need to complete the 12 weeks of treatments.
This is four arm study. Approximately 480 (120 per group) would need to complete the 12 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 followed by at least 2 weeks (14 days) placebo Run-in
Period during which asthma subjects will wash out their daily inhaled corticosteroid and
other medications and be assessed for compliance.
Study treatment period will be for a duration of 12 weeks with visits: Visit 2- Baseline Day
1, Visit 3 Day 21 (± 2 days), Visit 4 Day 42 (± 2 days), Visit 5 Day 63 (± 2 days), and Visit
6 Day 84 days (± 2 days).
Rescue Therapy: Short-acting beta agonists, Albuterol 90 μg/actuation.
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