Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06003049
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2023-08-04
Brief Title:
A Study to Evaluate Safety and Efficacy of BOTOX in Adults With Moderate COPD
Sponsor:
RMW Testing
Organization:
RMW Testing
Study Overview
Official Title:
An Investigator-Initiated Single Center Prospective Double-Blind Randomized Placebo-Controlled Study to Evaluate Safety and Efficacy of OnabotulinumtoxinA BOTOX in Adults With Moderate Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this clinical trial to determine the safety and effectiveness of treating the COPD symptoms with subcutaneous BOTOX injections in participants with moderate COPD
Detailed Description:
This is a prospective double-blind randomized placebo-controlled investigator-initiated clinical trial to assess the safety tolerability and efficacy using an approved drug BOTOX in moderate COPD participants
Forty participants with moderate COPD defined as mMRC Dyspnea Scale scores of grades 2 or 3 and CAT scores of 12 to 20 will be included If eligibility criteria are met subjects will be randomized to either the treatment arm BOTOX or placebo treated on day one and observed for 90 days for safety and efficacy
Forty participants with moderate COPD defined as mMRC Dyspnea Scale scores of grades 2 or 3 and CAT scores of 12 to 20 will be included If eligibility criteria are met subjects will be randomized to either the treatment arm BOTOX or placebo treated on day one and observed for 90 days for safety and efficacy
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