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

Chronic Bronchitis Clinical Trial

— AHR CB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05843669
• Other study ID #: 5132-02-2023
• Status: Recruiting
• Phase: Phase 4
• Start date: July 6, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: July 2023
• Source: American Health Research
• Contact: Selwyn Spangenthal, MD
• Phone: 704-926-8041
• Email: sspangenthal[@]charlottelung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis

Intervention

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.

Locations

Country	Name	City	State
United States	American Health Research	Charlotte	North Carolina
United States	Clinical Research of Rock Hill	Rock Hill	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
American Health Research	Vitaccess Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Other	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.
Other	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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).
Primary	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	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.
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).