Beclomethasone Dipropionate HFA in Adult and Adolescent Subjects With Persistent Asthma

Phase 3

Withdrawn

• Conditions: Asthma
• Interventions: Drug: Beclomethasone 800 µg per day; Drug: Beclomethasone 640 µg per day; Drug: Placebo; Drug: Beclomethasone 400 µg per day

• Registration Number: NCT03834012
• Lead Sponsor: Adamis Pharmaceuticals Corporation

Brief 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

Study Timeline

• Study Start: 2019-02
• Study First Submitted: 2019-02-06
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-07
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-17
• Primary Completion: 2019-11
• Study Completion: 2020-04

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• Status: WITHDRAWN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
Beclomethasone 800 µg per day	Beclomethasone 800 µg per day	Intervention: Drug: Beclomethasone 800 ug per day Daily dose of Beclomethasone 800 ug 4 inhalations 100 μg ex-valve 2 times a day for 6 weeks
Beclomethasone 640 µg per day	Beclomethasone 640 µg per day	Intervention: Drug: Beclomethasone 640 µg per day 4 inhalations 80 μg ex-actuator 2 times a day for 6 weeks
Placebo	Placebo	Intervention: Drug: placebo 4 inhalations 2 times a day for 6 weeks
Beclomethasone 400 µg per day	Placebo	Intervention: Drug: Beclomethasone 400 µg per day Daily dose of Beclomethasone 400 µg 2 inhalations 100 μg ex-valve 2 times a day for 6 weeks Intervention: Drug: Placebo 2 inhalations 2 times a day for 6 weeks
Beclomethasone 400 µg per day	Beclomethasone 400 µg per day	Intervention: Drug: Beclomethasone 400 µg per day Daily dose of Beclomethasone 400 µg 2 inhalations 100 μg ex-valve 2 times a day for 6 weeks Intervention: Drug: Placebo 2 inhalations 2 times a day for 6 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in FEV1 percent predicted compared to placebo	6 weeks	The primary analysis of change from baseline trough (pre-dose and pre-rescue bronchodilator) FEV1 percent predicted (0-6 weeks) will be carried out on the mITT Population using analysis of covariance (ANCOVA) with treatment as an effect, and status of previous steroid use (naïve or prior use) as the covariate. The efficacy endpoint for the primary analysis is the change from baseline trough FEV1%- predicted at week 6.

Secondary Outcome Measures

Name	Time	Method
AUC at week in FEV1 compared to placebo	6 weeks	Continuous secondary efficacy endpoints and other continuous tertiary efficacy endpoints will be analyzed similarly to that specified for the primary endpoint. After FEV1%-predicted is estimated for all scheduled visits (either as observed or as imputed for missing), AUC0-6 FEV1 percent predicted (0-6 weeks) will be calculated and Satterhwaite t-test will be used to compare the difference on AUC0-6 between treatment groups and placebo.