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

Completed · Phase 4

Conditions studied: Chronic Bronchitis

In brief

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).

Key facts

Study ID

NCT05843669

Run by

American Health Research

People needed

82

Starts

2023-07-17

Expected to finish

2024-11-13

Last updated by the study team

2026-03-20

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• American Health Research — Charlotte, North Carolina, United States
• Clinical Research of Rock Hill — Rock Hill, South Carolina, United States

Full record on ClinicalTrials.gov

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