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

Sponsor
Vitaccess Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05843669
Collaborator
American Health Research (Other)
150
2
1
12
75
6.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Guafenesin tablets
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Phase 4 real-world studyPhase 4 real-world study
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

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®
  • Outcome Measures

    Primary Outcome Measures

    1. Describe patient-reported real-world clinical use of Mucinex® (i.e., prior to study start) in patients with SCB. [At baseline (week 0).]

      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.

    2. Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment compliance) in patients with SCB. [Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).]

      Patient-reported quantitative data via "Treatment compliance" bespoke survey.

    3. Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB. [Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).]

      Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.

    4. Describe change in patient-reported real-world clinical use of Mucinex® (i.e., symptoms) in patients with SCB. [Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).]

      Patient-reported quantitative data via "Symptoms" bespoke survey.

    5. Describe change in patient-reported real-world clinical use of Mucinex® (i.e., cough and sputum production and its impact) in patients with SCB. [Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).]

      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

    6. Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment-emergent adverse events) in patients with SCB. [As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).]

      HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).

    7. Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB. [At final visit (week 14).]

      HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).

    8. Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., energy levels) in patients with SCB. [At week 8, and at final visit (week 14).]

      HCP-reported quantitative data via electronic case report forms ("Energy levels" survey).

    9. Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., healthcare resource use) in patients with SCB. [At baseline visit (week 0), at week 8, and at final visit (week 14).]

      HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).

    Secondary Outcome Measures

    1. 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.]

      Patient-reported quantitative data via the Cough and Sputum Assessment Questionnaire, CASA-Q (web- and app-based).

    2. 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).]

      HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).

    3. 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).]

      HCP-reported quantitative data via electronic case report forms ("Healthcare resource use" survey).

    4. Assess HCP-reported treatment satisfaction of patients while on treatment with Mucinex®. [At final visit (week 14).]

      HCP-reported quantitative data via electronic case report forms ("Treatment satisfaction" survey).

    5. Assess patient-reported treatment satisfaction while on treatment with Mucinex®. [Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).]

      Patient-reported quantitative data via "Treatment satisfaction" bespoke survey.

    Other Outcome Measures

    1. 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).]

      HCP-reported quantitative data via electronic case report forms ("Treatment-emergent adverse events" survey).

    2. 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.]

      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

    3. 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).]

      HCP-reported quantitative data via electronic case report forms ("Energy levels" survey).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 American Health Research Charlotte North Carolina United States 28270
    2 Clinical Research of Rock Hill Rock Hill South Carolina United States 29732

    Sponsors and Collaborators

    • Vitaccess Ltd
    • American Health Research

    Investigators

    • Principal Investigator: Selwyn Spangenthal, MD, American Health Research; Clinical Research of Rock Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mark Larkin, CEO, Vitaccess Ltd
    ClinicalTrials.gov Identifier:
    NCT05843669
    Other Study ID Numbers:
    • 5132-02-2023
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Mark Larkin, CEO, Vitaccess Ltd
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 6, 2023