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A Study to Explore if Long-term Use of Mucinex Can Help With Symptoms in Patients With Stable Chronic Bronchitis. (AHR CB)

Primary Purpose

Chronic Bronchitis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Guafenesin tablets
Sponsored by
American Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Bronchitis focused on measuring Stable chronic bronchitis, Real-world study, Mucinex, Guafenesin

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients with a diagnosis of SCB at recruitment, male and female, over 40 years of age A Pulmonary Function Test with FEV1/FVC less than 0.7 (70%) at the time of enrollment or at least a 10 year history of cigarette abuse. Patients who have chronic sputum production 3 months out of the year for 2 consecutive years and a productive cough as part of their symptoms. Patients who understand and are able to fill out a questionnaire and ePRO weekly Patients who have not used guaifenesin containing products within one month of the time of study enrollment Patients with 6 to 12 (ideally 12)-month historical data - retrieved from either electronic medical records (EMR), electronic health records (EHRs), or provided by the patient via interview. Rescue medicine: • No rescue medicine will be provided. Information regarding concurrent rescue medications, either OTC or via prescription, will be collected. Exclusion Criteria: Patients who are pregnant or breastfeeding Participation in another study involving an investigational product within 30 days of the baseline visit Pulmonary diagnosis other than CB, (such as cystic fibrosis, alpha-1 antitrypsin deficiency, bronchiectasis, or pulmonary fibrosis) Active lung cancer or history of lung cancer if it has been less than 2 years since lung resection or other treatment including chemotherapy or radiation. If the patient has a history of lung cancer, they must be in remission Psychiatric disorder that precludes participation in the study History of alcohol and/or drug abuse within one year of study start Patients taking intermittent antibiotics and patients taking oral and systemic corticosteroids (e.g., prednisone at a dose of > 10 mg/day). Patients on a chronic stable dose of macrolide antibiotics at the start of the study may be included at the discretion of the Principal Investigator. Patients who had an acute exacerbation of chronic bronchitis within a period of one month of starting the study that required systematic steroids or antibiotics Hypersensitivity to guaifenesin, or any other excipient listed in the product.

Sites / Locations

  • American Health ResearchRecruiting
  • Clinical Research of Rock Hill

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

N/A. Only one arm.

Arm Description

Single arm. 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.

Outcomes

Primary Outcome Measures

Describe patient-reported real-world clinical use of Mucinex® (i.e., prior to study start) in patients with SCB.
Patient-reported quantitative data via "Prior usage of Mucinex®" bespoke survey. This comprises three questions regarding patients' previous use of Mucinex, the approximate timing of use, and the frequency of use.
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment compliance) in patients with SCB.
Patient-reported quantitative data via "Treatment compliance" bespoke survey.
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.
Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., symptoms) in patients with SCB.
Patient-reported quantitative data via "Symptoms" bespoke survey.
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., cough and sputum production and its impact) in patients with SCB.
Patient-reported quantitative data via the Cough and Sputum Assessment Questionnaire, CASA-Q (web- and app-based). This is a validated instrument to measure cough and sputum production, and their impact in patients with chronic obstructive pulmonary disease (COPD) and/or chronic bronchitis
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment-emergent adverse events) in patients with SCB.
HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.
HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., energy levels) in patients with SCB.
HCP-reported quantitative data via electronic case report forms ("Energy levels" survey).
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., healthcare resource use) in patients with SCB.
HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).

Secondary Outcome Measures

Describe the rate of patient-reported chronic bronchitis ePRO improvements while on treatment with Mucinex® compared to patient history or baseline.
Patient-reported quantitative data via the Cough and Sputum Assessment Questionnaire, CASA-Q (web- and app-based).
Describe the rate of concomitant rescue and/or maintenance inhaler use while on treatment with Mucinex® compared to patient history/baseline established as part of Medication Record Log completed by HCP in the eCRF at baseline visit.
HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).
Describe the HCP-reported rate of healthcare resource utilization while on treatment with Mucinex® compared to patient history or baseline.
HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).
Assess HCP-reported treatment satisfaction of patients while on treatment with Mucinex®.
HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).
Assess patient-reported treatment satisfaction while on treatment with Mucinex®.
Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.

Full Information

First Posted
April 6, 2023
Last Updated
July 6, 2023
Sponsor
American Health Research
Collaborators
Vitaccess Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05843669
Brief Title
A Study to Explore if Long-term Use of Mucinex Can Help With Symptoms in Patients With Stable Chronic Bronchitis.
Acronym
AHR CB
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Health Research
Collaborators
Vitaccess Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 Real[TM] 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Bronchitis
Keywords
Stable chronic bronchitis, Real-world study, Mucinex, Guafenesin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Phase 4 real-world study
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N/A. Only one arm.
Arm Type
Experimental
Arm Description
Single arm. 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.
Intervention Type
Drug
Intervention Name(s)
Guafenesin tablets
Other Intervention Name(s)
Mucinex®
Intervention Description
During the 12-week period of receiving treatment, patient participants will take Mucinex® 12h, 2 x 600 mg (1200 mg total) twice daily.
Primary Outcome Measure Information:
Title
Describe patient-reported real-world clinical use of Mucinex® (i.e., prior to study start) in patients with SCB.
Description
Patient-reported quantitative data via "Prior usage of Mucinex®" bespoke survey. This comprises three questions regarding patients' previous use of Mucinex, the approximate timing of use, and the frequency of use.
Time Frame
At baseline (week 0).
Title
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment compliance) in patients with SCB.
Description
Patient-reported quantitative data via "Treatment compliance" bespoke survey.
Time Frame
Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
Title
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.
Description
Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.
Time Frame
Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).
Title
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., symptoms) in patients with SCB.
Description
Patient-reported quantitative data via "Symptoms" bespoke survey.
Time Frame
Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
Title
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., cough and sputum production and its impact) in patients with SCB.
Description
Patient-reported quantitative data via the Cough and Sputum Assessment Questionnaire, CASA-Q (web- and app-based). This is a validated instrument to measure cough and sputum production, and their impact in patients with chronic obstructive pulmonary disease (COPD) and/or chronic bronchitis
Time Frame
Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
Title
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment-emergent adverse events) in patients with SCB.
Description
HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).
Time Frame
As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
Title
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.
Description
HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).
Time Frame
At final visit (week 14).
Title
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., energy levels) in patients with SCB.
Description
HCP-reported quantitative data via electronic case report forms ("Energy levels" survey).
Time Frame
At week 8, and at final visit (week 14).
Title
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., healthcare resource use) in patients with SCB.
Description
HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).
Time Frame
At baseline visit (week 0), at week 8, and at final visit (week 14).
Secondary Outcome Measure Information:
Title
Describe the rate of patient-reported chronic bronchitis ePRO improvements while on treatment with Mucinex® compared to patient history or baseline.
Description
Patient-reported quantitative data via the Cough and Sputum Assessment Questionnaire, CASA-Q (web- and app-based).
Time Frame
At baseline (week 0), and every 1 week during 14 week study period.
Title
Describe the rate of concomitant rescue and/or maintenance inhaler use while on treatment with Mucinex® compared to patient history/baseline established as part of Medication Record Log completed by HCP in the eCRF at baseline visit.
Description
HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).
Time Frame
As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
Title
Describe the HCP-reported rate of healthcare resource utilization while on treatment with Mucinex® compared to patient history or baseline.
Description
HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).
Time Frame
At baseline visit (week 0), at week 8, and at final visit (week 14).
Title
Assess HCP-reported treatment satisfaction of patients while on treatment with Mucinex®.
Description
HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).
Time Frame
At final visit (week 14).
Title
Assess patient-reported treatment satisfaction while on treatment with Mucinex®.
Description
Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.
Time Frame
Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).
Other Pre-specified Outcome Measures:
Title
Rate of chronic bronchitis exacerbations in patients who use Mucinex® to manage symptoms of SCB.
Description
HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).
Time Frame
As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
Title
Change in patient-reported health-related quality of life in patients who use Mucinex® to manage symptoms of SCB
Description
Patient-reported quantitative data via the Cough and Sputum Assessment Questionnaire, CASA-Q (web- and app-based). This is a validated instrument to measure cough and sputum production, and their impact in patients with chronic obstructive pulmonary disease (COPD) and/or chronic bronchitis
Time Frame
At baseline (week 0), and every 1 week during 14 week study period.
Title
Change in HCP-reported health-related quality of life in patients who use Mucinex® to manage symptoms of SCB.
Description
HCP-reported quantitative data via electronic case report forms ("Energy levels" survey).
Time Frame
At week 8, and at final visit (week 14).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients with a diagnosis of SCB at recruitment, male and female, over 40 years of age A Pulmonary Function Test with FEV1/FVC less than 0.7 (70%) at the time of enrollment or at least a 10 year history of cigarette abuse. Patients who have chronic sputum production 3 months out of the year for 2 consecutive years and a productive cough as part of their symptoms. Patients who understand and are able to fill out a questionnaire and ePRO weekly Patients who have not used guaifenesin containing products within one month of the time of study enrollment Patients with 6 to 12 (ideally 12)-month historical data - retrieved from either electronic medical records (EMR), electronic health records (EHRs), or provided by the patient via interview. Rescue medicine: • No rescue medicine will be provided. Information regarding concurrent rescue medications, either OTC or via prescription, will be collected. Exclusion Criteria: Patients who are pregnant or breastfeeding Participation in another study involving an investigational product within 30 days of the baseline visit Pulmonary diagnosis other than CB, (such as cystic fibrosis, alpha-1 antitrypsin deficiency, bronchiectasis, or pulmonary fibrosis) Active lung cancer or history of lung cancer if it has been less than 2 years since lung resection or other treatment including chemotherapy or radiation. If the patient has a history of lung cancer, they must be in remission Psychiatric disorder that precludes participation in the study History of alcohol and/or drug abuse within one year of study start Patients taking intermittent antibiotics and patients taking oral and systemic corticosteroids (e.g., prednisone at a dose of > 10 mg/day). Patients on a chronic stable dose of macrolide antibiotics at the start of the study may be included at the discretion of the Principal Investigator. Patients who had an acute exacerbation of chronic bronchitis within a period of one month of starting the study that required systematic steroids or antibiotics Hypersensitivity to guaifenesin, or any other excipient listed in the product.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Selwyn Spangenthal, MD
Phone
704-926-8041
Email
sspangenthal@charlottelung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Connie Divel, BSc
Phone
704-926-8041
Email
cdivel@ahres.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selwyn Spangenthal, MD
Organizational Affiliation
American Health Research; Clinical Research of Rock Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28270
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Connie Divel, BSc
Phone
704-926-8041
Email
cdivel@ahres.com
First Name & Middle Initial & Last Name & Degree
Selwyn Spangenthal, MD
Facility Name
Clinical Research of Rock Hill
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Reynolds
Phone
803-251-9501
Email
creynolds@cresrh.com
First Name & Middle Initial & Last Name & Degree
Selwyn Spangenthal, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

A Study to Explore if Long-term Use of Mucinex Can Help With Symptoms in Patients With Stable Chronic Bronchitis.

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