A Phase 4 interventional study of Guafenesin tablets in Chronic Bronchitis, sponsored by American Health Research. Completed at 2 sites in United States. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by American Health Research · Phase 4, Interventional, and Treatment
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).
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.
209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.
This study's enrollment of 82 is below the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.
Browse Bronchitis, Chronic studies →This is the only study on the registry with American Health Research as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Rescue medicine:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Mucinex®
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: At baseline visit (week 0), at week 8, and at final visit (week 14).
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: At final visit (week 14).
Assess patient-reported treatment satisfaction while on treatment with Mucinex®.
Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.
Time frame: Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).
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).
Time frame: 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
Time frame: 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).
Time frame: At week 8, and at final visit (week 14).
Plan to share: No — There is not a plan to make IPD available.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Guaifenesin