Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05843669
Status:
RECRUITING
Last Update Posted:
2023-07-07
First Post:
2023-04-06
Brief Title:
A Study to Explore if Long-term Use of Mucinex Can Help With Symptoms in Patients With Stable Chronic Bronchitis
Sponsor:
American Health Research
Organization:
American Health Research
Study Overview
Official Title:
An Open-label Multicenter Single-group Study to Evaluate the Effects of Long-term Use of Mucinex in Patients With Stable Chronic Bronchitis
Status:
RECRUITING
Status Verified Date:
2023-07
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:
AHR CB
Brief Summary:
This is an open-label multicenter single-group study designed to determine the effectiveness of Mucinex when used by patients to treat SCB over a 12-week period following a 2-week run-in period of no treatment to establish a baseline
Detailed Description:
Data will be collected via the Vitaccess RealTM platform from adult patients with SCB and HCPs based in the US During the 12-week period of receiving treatment patient participants will take Mucinex 12h 2 x 600 mg 1200 mg total twice daily and complete weekly bespoke surveys and the CASA-Q instrument Patient-reported data will include prior usage of Mucinex treatment compliance treatment satisfaction and symptoms
During this same period of time HCPs will report treatment satisfaction via electronic case report forms eCRFs and will also have the ability to spontaneously report any treatment-emergent adverse events
During this same period of time HCPs will report treatment satisfaction via electronic case report forms eCRFs and will also have the ability to spontaneously report any treatment-emergent adverse events
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?:
False
Is an FDA AA801 Violation?:
None