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

NCT05843669 | Completed Phase 4 FDA Drug

• 1 other identifier: 5132-02-2023
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Chronic Bronchitis

Keywords

Stable chronic bronchitis; Real-world study; Mucinex; Guafenesin

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (5)

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

  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.

  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.

  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®.

  At final visit (week 14).

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

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

Other Outcomes (3)

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

  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

  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.

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

Study Arms (1)

N/A. Only one arm.

EXPERIMENTAL

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

Interventions

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.

Also known as: Mucinex®

N/A. Only one arm.

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vitaccess Ltd: collaborator
• American Health Research: lead

Study Sites (2)

American Health Research

Charlotte, North Carolina, 28277, United States

Location

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

Location

Related Publications (6)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Bronchitis, Chronic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Selwyn Spangenthal, MD

  American Health Research; Clinical Research of Rock Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 4 real-world study

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 6, 2023
• Study Start: July 17, 2023
• Primary Completion: September 30, 2024
• Study Completion: November 13, 2024
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)