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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Chronic Bronchitis

Intervention / Treatment
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* Drug: Guafenesin tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Phase 4 real-world study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: N/A. Only one arm.<br>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<br>* During the 12-week period of receiving treatment, patient participants will take Mucinex® 12h, 2 x 600 mg (1200 mg total) twice daily.<br>* Other names: Mucinex®;|

What is the study measuring?
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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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mucinex, Stable chronic bronchitis, Real-world study, Guafenesin