Ignite Creation Date:
2024-05-06 @ 12:45 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03834012
Status:
WITHDRAWN
Last Update Posted:
2019-07-17
First Post:
2019-02-06
Brief Title:
Beclomethasone Dipropionate HFA in Adult and Adolescent Subjects With Persistent Asthma
Sponsor:
Adamis Pharmaceuticals Corporation
Organization:
Adamis Pharmaceuticals Corporation
Study Overview
Official Title:
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WITHDRAWN
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 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 μgactuation
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 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