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

Phase 3

Withdrawn

• Conditions: Asthma
• Interventions: Drug: 400 µg per day Beclomethasone; Drug: Placebo; Drug: 200 µg per day Beclomethasone; Drug: 100 µg per day Beclomethasone

• Registration Number: NCT03835871
• Lead Sponsor: Adamis Pharmaceuticals Corporation

Brief 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.

Study Timeline

• Study Start: 2019-02
• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-17
• Primary Completion: 2019-12
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
400 µg per day Beclomethasone	400 µg per day Beclomethasone	Intervention: Drug: Beclomethasone 400 µg per day Daily dose of Beclomethasone 400 µg 2 inhalations 100 μg ex-valve 2 times a day for 12 weeks
200 µg per day Beclomethasone	Placebo	Intervention: Drug: Beclomethasone 200 µg per day Daily dose of Beclomethasone 200 µg 1 inhalation 100 μg ex-valve 2 times a day for 12 weeks Intervention: Drug: Placebo 1 inhalation 2 times a day for 12 weeks
200 µg per day Beclomethasone	200 µg per day Beclomethasone	Intervention: Drug: Beclomethasone 200 µg per day Daily dose of Beclomethasone 200 µg 1 inhalation 100 μg ex-valve 2 times a day for 12 weeks Intervention: Drug: Placebo 1 inhalation 2 times a day for 12 weeks
100 µg per day Beclomethasone	Placebo	Intervention: Drug: Beclomethasone 100 µg per day Daily dose of Beclomethasone 100 µg 1 inhalation 50 μg ex-valve 2 times a day for 12 weeks Intervention: Drug: Placebo 1 inhalation 2 times a day for 12 weeks
100 µg per day Beclomethasone	100 µg per day Beclomethasone	Intervention: Drug: Beclomethasone 100 µg per day Daily dose of Beclomethasone 100 µg 1 inhalation 50 μg ex-valve 2 times a day for 12 weeks Intervention: Drug: Placebo 1 inhalation 2 times a day for 12 weeks
placebo	Placebo	Intervention: Drug: placebo 2 inhalations 2 times a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Mean Change from baseline trough (pre-dose and pre-rescue) FEV1 percent predicted at week 12	12 weeks	Mean Change from baseline trough (pre-dose and pre-rescue) FEV1 percent predicted at week 12