Clinical trial NCT05843669: A Study to Explore if Long-term Use of Mucinex Can Help With Symptoms in Patients With Stable Chronic Bronchitis.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Bronchitis
Keywords: Stable chronic bronchitis
Real-world study
Mucinex
Guafenesin
Lead sponsor: American Health Research
Sponsor class: OTHER
Collaborators: name: Vitaccess Ltd
First posted: 2023-05-06
Enrollment: 82
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase 4 real-world study
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Describe patient-reported real-world clinical use of Mucinex® (i.e., prior to study start) in patients with SCB.
timeFrame: At baseline (week 0).
measure: Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment compliance) in patients with SCB.
timeFrame: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
measure: Describe change in patient-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.
timeFrame: Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).
measure: Describe change in patient-reported real-world clinical use of Mucinex® (i.e., symptoms) in patients with SCB.
timeFrame: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
measure: Describe change in patient-reported real-world clinical use of Mucinex® (i.e., cough and sputum production and its impact) in patients with SCB.
timeFrame: Every 1 week during 12 week period of receiving Mucinex® (week 2 to 14).
measure: Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment-emergent adverse events) in patients with SCB.
timeFrame: As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
measure: Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., treatment satisfaction) in patients with SCB.
timeFrame: At final visit (week 14).
measure: Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., energy levels) in patients with SCB.
timeFrame: At week 8, and at final visit (week 14).
measure: Describe change in HCP-reported real-world clinical use of Mucinex® (i.e., healthcare resource use) in patients with SCB.
timeFrame: At baseline visit (week 0), at week 8, and at final visit (week 14).
Secondary outcomes:
measure: Describe the rate of patient-reported chronic bronchitis ePRO improvements while on treatment with Mucinex® compared to patient history or baseline.
timeFrame: At baseline (week 0), and every 1 week during 14 week study period.
measure: 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.
timeFrame: As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
measure: Describe the HCP-reported rate of healthcare resource utilization while on treatment with Mucinex® compared to patient history or baseline.
timeFrame: At baseline visit (week 0), at week 8, and at final visit (week 14).
measure: Assess HCP-reported treatment satisfaction of patients while on treatment with Mucinex®.
timeFrame: At final visit (week 14).
measure: Assess patient-reported treatment satisfaction while on treatment with Mucinex®.
timeFrame: Every 2 weeks during 12 week period of receiving Mucinex® (week 2 to 14).
Other outcomes:
measure: Rate of chronic bronchitis exacerbations in patients who use Mucinex® to manage symptoms of SCB.
timeFrame: As many times as needed during 12 week period of receiving Mucinex® (week 2 to 14).
measure: Change in patient-reported health-related quality of life in patients who use Mucinex® to manage symptoms of SCB
timeFrame: At baseline (week 0), and every 1 week during 14 week study period.
measure: Change in HCP-reported health-related quality of life in patients who use Mucinex® to manage symptoms of SCB.
timeFrame: At week 8, and at final visit (week 14).
Locations:
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
Study officials:
affiliation: American Health Research; Clinical Research of Rock Hill
name: Selwyn Spangenthal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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