Skip to main content
OpenTrials
Completed

NCT Number: NCT05843669

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

American Health Research, Charlotte, North Carolina, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guafenesin tablets

Drug

During the 12-week period of receiving treatment, patient participants will take Mucinex® 12h, 2 x 600 mg (1200 mg total) twice daily.

Other names: Mucinex®

Primary outcomes

  1. Describe patient-reported real-world clinical use of Mucinex® (i.e., prior to study start) in patients with SCB.

    Time frame: At baseline (week 0).

    Patient-reported quantitative data via "Prior usage of Mucinex®" bespoke survey. This comprises three questions regarding patients' previous use of Mucinex, the approximate timing of use, and the frequency of use.

  2. Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment compliance) in patients with SCB.

    Time frame: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).

    Patient-reported quantitative data via "Treatment compliance" bespoke survey.

  3. Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.

    Time frame: Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).

    Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.

  4. Describe change in patient-reported real-world clinical use of Mucinex® (i.e., symptoms) in patients with SCB.

    Time frame: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).

    Patient-reported quantitative data via "Symptoms" bespoke survey.

  5. Describe change in patient-reported real-world clinical use of Mucinex® (i.e., cough and sputum production and its impact) in patients with SCB.

    Time frame: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).

    Patient-reported quantitative data via the Cough and Sputum Assessment Questionnaire, CASA-Q (web- and app-based). This is a validated instrument to measure cough and sputum production, and their impact in patients with chronic obstructive pulmonary disease (COPD) and/or chronic bronchitis

  6. Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment-emergent adverse events) in patients with SCB.

    Time frame: As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).

    HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).

  7. Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.

    Time frame: At final visit (week 14).

    HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).

  8. Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., energy levels) in patients with SCB.

    Time frame: At week 8, and at final visit (week 14).

    HCP-reported quantitative data via electronic case report forms ("Energy levels" survey).

  9. Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., healthcare resource use) in patients with SCB.

    Time frame: At baseline visit (week 0), at week 8, and at final visit (week 14).

    HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).

Secondary outcomes

  1. Describe the rate of patient-reported chronic bronchitis ePRO improvements while on treatment with Mucinex® compared to patient history or baseline.

    Time frame: At baseline (week 0), and every 1 week during 14 week study period.

    Patient-reported quantitative data via the Cough and Sputum Assessment Questionnaire, CASA-Q (web- and app-based).

  2. Describe the rate of concomitant rescue and/or maintenance inhaler use while on treatment with Mucinex® compared to patient history/baseline established as part of Medication Record Log completed by HCP in the eCRF at baseline visit.

    Time frame: As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).

    HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).

  3. Describe the HCP-reported rate of healthcare resource utilization while on treatment with Mucinex® compared to patient history or baseline.

    Time frame: At baseline visit (week 0), at week 8, and at final visit (week 14).

    HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).

  4. Assess HCP-reported treatment satisfaction of patients while on treatment with Mucinex®.

    Time frame: At final visit (week 14).

    HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).

  5. Assess patient-reported treatment satisfaction while on treatment with Mucinex®.

    Time frame: Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).

    Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.

Other outcomes

  1. Rate of chronic bronchitis exacerbations in patients who use Mucinex® to manage symptoms of SCB.

    Time frame: As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).

    HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).

  2. Change in patient-reported health-related quality of life in patients who use Mucinex® to manage symptoms of SCB

    Time frame: At baseline (week 0), and every 1 week during 14 week study period.

    Patient-reported quantitative data via the Cough and Sputum Assessment Questionnaire, CASA-Q (web- and app-based). This is a validated instrument to measure cough and sputum production, and their impact in patients with chronic obstructive pulmonary disease (COPD) and/or chronic bronchitis

  3. Change in HCP-reported health-related quality of life in patients who use Mucinex® to manage symptoms of SCB.

    Time frame: At week 8, and at final visit (week 14).

    HCP-reported quantitative data via electronic case report forms ("Energy levels" survey).

Sponsors and collaborators

Lead sponsor

American Health Research

Other

Collaborators

  • Vitaccess Ltd

Registry information

Official study title

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

Acronym: AHR CB

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.