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

An Open-label, Multicenter, Single-group Study to Evaluate the Effects of Long-term Use of Mucinex® 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).

Study Overview

• Status: Completed
• Conditions: Chronic Bronchitis
• Intervention / Treatment: Drug: Guafenesin tablets

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • American Health Research
  • South Carolina
    • Rock Hill, South Carolina, United States, 29732
      • Clinical Research of Rock Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: N/A. Only one arm.; Single arm. 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.	Drug: Guafenesin tablets; 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe patient-reported real-world clinical use of Mucinex® (i.e., prior to study start) in patients with SCB.	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.	At baseline (week 0).
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment compliance) in patients with SCB.	Patient-reported quantitative data via "Treatment compliance" bespoke survey.	Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.	Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.	Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., symptoms) in patients with SCB.	Patient-reported quantitative data via "Symptoms" bespoke survey.	Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
Describe change in patient-reported real-world clinical use of Mucinex® (i.e., cough and sputum production and its impact) in patients with SCB.	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	Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment-emergent adverse events) in patients with SCB.	HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).	As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.	HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).	At final visit (week 14).
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., energy levels) in patients with SCB.	HCP-reported quantitative data via electronic case report forms ("Energy levels" survey).	At week 8, and at final visit (week 14).
Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., healthcare resource use) in patients with SCB.	HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).	At baseline visit (week 0), at week 8, and at final visit (week 14).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe the rate of patient-reported chronic bronchitis ePRO improvements while on treatment with Mucinex® compared to patient history or baseline.	Patient-reported quantitative data via the Cough and Sputum Assessment Questionnaire, CASA-Q (web- and app-based).	At baseline (week 0), and every 1 week during 14 week study period.
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.	HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).	As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
Describe the HCP-reported rate of healthcare resource utilization while on treatment with Mucinex® compared to patient history or baseline.	HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).	At baseline visit (week 0), at week 8, and at final visit (week 14).
Assess HCP-reported treatment satisfaction of patients while on treatment with Mucinex®.	HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).	At final visit (week 14).
Assess patient-reported treatment satisfaction while on treatment with Mucinex®.	Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.	Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of chronic bronchitis exacerbations in patients who use Mucinex® to manage symptoms of SCB.	HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).	As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
Change in patient-reported health-related quality of life in patients who use Mucinex® to manage symptoms of SCB	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	At baseline (week 0), and every 1 week during 14 week study period.
Change in HCP-reported health-related quality of life in patients who use Mucinex® to manage symptoms of SCB.	HCP-reported quantitative data via electronic case report forms ("Energy levels" survey).	At week 8, and at final visit (week 14).

Collaborators and Investigators

• Sponsor: American Health Research
• Collaborators: Vitaccess Ltd
• Investigators: Principal Investigator: Selwyn Spangenthal, MD, American Health Research; Clinical Research of Rock Hill

Publications and helpful links

General Publications

• Divel C, Spangenthal S, Shea T, Borecka O, Llewellyn S, Adeleke M, Patel P. Adjunctive long-term Mucinex® use leading to improvement in stable chronic bronchitis and decreased health care resource utilization - a case report. Am J Respir Crit Care Med 2025;211:A6293. https://doi.org/10.1164/ajrccm.2025.211.Abstracts.A6293
• Spangenthal S, Divel C, Borecka O, Fellows A, Llewellyn S. The interplay between CASA-Q domains: insights from a real-world study investigating the effects of extended-release guaifenesin in stable chronic bronchitis. Presented at the 10th American Cough Conference (ACC) 2025; Jun 2025; Dulles, VA, US. https://www.researchgate.net/publication/391522663
• Spangenthal S, Llewellyn S, Borecka O, Pollack C, Adeleke M, Kulasekaran A, Birring S, Mazzone S, Shea T. Real world effectiveness of guaifenesin ER in tackling mucus hypersecretion in stable chronic bronchitis. Presented at The Thirteenth London International Cough Symposium; Jul 18-19; London, UK https://www.researchgate.net/publication/382744095
• Divel C, Borecka O, Llewellyn S, Spangenthal S. Assessment of stable chronic bronchitis improvement with adjunctive long-term Mucinex® use via the cough and sputum assessment questionnaire (CASA-Q). Presented at The Annual Meeting of the American College of Chest Physicians (CHEST) 2025; Oct 19-22; Chicago, IL, US. https://journal.chestnet.org/article/S0012-3692(25)04707-5/fulltext
• Spangenthal S, Divel C, Borecka O, Llewellyn S. Real-world use of Vitaccess Real™ platform to assess quality of life impact with long-term use of Mucinex® in stable chronic bronchitis. Presented at the 32nd International Society of Quality of Life Research (ISOQOL) Annual Conference 2025; Oct 22-25; Milwaukee, WI, US. https://www.researchgate.net/publication/394966835
• Spangenthal S, Divel C, Borecka O, Llewellyn S. Adjunctive long-term use of Mucinex® leading to improvement in stable chronic bronchitis and patient's quality of life: A case report. Medical Reports 2025;14:100384. https://www.sciencedirect.com/science/article/pii/S2949918625002293

Helpful Links

• The Thirteenth London International Cough Symposium research poster
• ACC 2025 presentation
• ISOQOL 2025 research poster

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): November 13, 2024

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Real-world study; Stable chronic bronchitis; Mucinex; Guafenesin
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Pulmonary Disease, Chronic Obstructive; Pathological Conditions, Signs and Symptoms; Bronchitis, Chronic; Amino Acids, Peptides, and Proteins; Sulfur Compounds; Organic Chemicals; Amino Acids; Cysteine; Amino Acids, Sulfur; Acetylcysteine
• Other Study ID Numbers: 5132-02-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No