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

COMPLETEDPHASE4

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

An Open-label, Multicenter, Single-group Study to Evaluate the Effects of Long-term Use of Mucinex® in Patients With Stable Chronic Bronchitis.

NCT05843669•American Health Research

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 90 years

Sex

ALL

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.

Locations (2)

American Health Research

Charlotte, North Carolina, United States

Clinical Research of Rock Hill

Rock Hill, South Carolina, United States

Key Dates

Start Date

July 17, 2023

Primary Completion Date

September 30, 2024

Completion Date

November 13, 2024

Last Updated

March 20, 2026

Enrollment

ACTUAL participants

Conditions

Chronic Bronchitis

Interventions

Guafenesin tablets

DRUG

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COMPLETEDPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of COPD Subgroups and Biomarkers

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