Ignite Creation Date:
2024-05-06 @ 12:43 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03835871
Status:
WITHDRAWN
Last Update Posted:
2019-07-17
First Post:
2019-02-07
Brief Title:
Beclomethasone Dipropionate HFA in Adult and Adolescent Subjects With Mild to Moderate Persistent Asthma
Sponsor:
Adamis Pharmaceuticals Corporation
Organization:
Adamis Pharmaceuticals Corporation
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 treatmentsIn 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 μgactuation
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 μgactuation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None