NCT03834012

Beclomethasone Dipropionate HFA in Adult and Adolescent Subjects With Persistent Asthma

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.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Adamis Pharmaceuticals Corporation · Industry
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Approximately 480 (120 per group) would need to complete the 6 weeks of treatments.

Detailed description

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

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Beclomethasone 800 µg per day	Intervention: Drug: Beclomethasone 800 µg HFA per day
DRUG	Placebo	Intervention: Drug: placebo
DRUG	Beclomethasone 400 µg per day	Intervention: Drug: Beclomethasone 400 µg HFA per day
DRUG	Beclomethasone 640 µg per day	Intervention: Drug: Beclomethasone 640 µg per day

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-11-01
• Completion: 2020-04-01
• First posted: 2019-02-07
• Last updated: 2019-07-17

Regulatory

• FDA-regulated drug study