NCT05843669CompletedPhase 4
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.
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 82 (actual)
- First submitted
- 6 Apr 2023
- Start date
- 17 Jul 2023
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- American Health Research
- Diseases
- COPD
- NCT number
- NCT05843669
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 82
- From 17 Jul 2023 to the primary completion date, 30 Sept 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another study involving an investigational product within 30 days of the baseline visit
- Patients taking intermittent antibiotics and patients taking oral and systemic corticosteroids (e.g., prednisone at a dose of \> 10 mg/day).
- 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
Other illness
- 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
- Hypersensitivity to guaifenesin, or any other excipient listed in the product.
Other
- Patients who are pregnant or breastfeeding
- Pulmonary diagnosis other than CB, (such as cystic fibrosis, alpha-1 antitrypsin deficiency, bronchiectasis, or pulmonary fibrosis)
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| American Health Research Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Clinical Research of Rock Hill Coordinator of this site? Confirm its status | Rock Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.