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

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vitaccess Ltd
• Collaborator: American Health Research

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.