NCT03835871

Beclomethasone Dipropionate HFA in Adult and Adolescent Subjects With Mild to Moderate Persistent Asthma

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

• Status: Withdrawn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 12 weeks of treatments.

Detailed description

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Placebo	Intervention: Drug: placebo
DRUG	400 µg per day Beclomethasone	Intervention: Drug: Beclomethasone 400 µg HFA per day
DRUG	200 µg per day Beclomethasone	Intervention: Drug: Beclomethasone 200 µg HFA per day
DRUG	100 µg per day Beclomethasone	Intervention: Drug: Beclomethasone 100 µg HFA per day

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-12-01
• Completion: 2020-05-01
• First posted: 2019-02-11
• Last updated: 2019-07-17

Regulatory

• FDA-regulated drug study