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

Last updated: February 6, 2025
Sponsor: American Health Research
Overall Status: Completed

Phase

4

Condition

Bronchiectasis

Bronchitis

Chronic Bronchitis

Treatment

Guafenesin tablets

Clinical Study ID

NCT05843669
5132-02-2023
  • Ages 40-90
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients with a diagnosis of SCB at recruitment, male and female, over 40years of age

  • A Pulmonary Function Test with FEV1/FVC less than 0.7 (70%) at the time ofenrollment or at least a 10 year history of cigarette abuse.

  • Patients who have chronic sputum production 3 months out of the year for 2consecutive 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 thetime of study enrollment

  • Patients with 6 to 12 (ideally 12)-month historical data - retrieved from eitherelectronic medical records (EMR), electronic health records (EHRs), or provided bythe 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

Exclusion Criteria:

  • Patients who are pregnant or breastfeeding

  • Participation in another study involving an investigational product within 30 daysof the baseline visit

  • Pulmonary diagnosis other than CB, (such as cystic fibrosis, alpha-1 antitrypsindeficiency, bronchiectasis, or pulmonary fibrosis)

  • Active lung cancer or history of lung cancer if it has been less than 2 years sincelung resection or other treatment including chemotherapy or radiation. If thepatient 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 systemiccorticosteroids (e.g., prednisone at a dose of > 10 mg/day).

  • Patients on a chronic stable dose of macrolide antibiotics at the start of the studymay be included at the discretion of the Principal Investigator.

  • Patients who had an acute exacerbation of chronic bronchitis within a period of onemonth of starting the study that required systematic steroids or antibiotics

  • Hypersensitivity to guaifenesin, or any other excipient listed in the product.

Study Design

Total Participants: 82
Treatment Group(s): 1
Primary Treatment: Guafenesin tablets
Phase: 4
Study Start date:
July 17, 2023
Estimated Completion Date:
November 13, 2024

Study 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.

Connect with a study center

  • American Health Research

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.