An open-label, multicenter, single-group study to evaluate the effects of long-term use of MUCINEX® in patients with stable chronic bronchitis

Spangenthal S, et al.

Presented at 13th International London Cough Symposium, 18–19 July 2024, in press: Journal of Thoracic Disease (JTD)

Purpose:

To determine the real-world effectiveness of MUCINEX^® (including dose, duration, and tolerability) when used by patients with stable chronic bronchitis (SCB).

Methods:

Single-group study of adults ≥40 years with SCB* (N=71)
Patients received MUCINEX^® extended-release tablets (2 x 600 mg guaifenesin) twice daily over a 12-week period following a 2-week run-in period of no treatment (baseline)
Patients received MUCINEX^® from Week 3 onwards in addition to their other prescribed medications
Cough and sputum assessment questionnaire (CASA-Q) assesses degree to which cough and phlegm affects the day-to-day quality of life of the surveyed patients

Key Findings (interim data):

	Majority of patients had high medication adherence throughout the treatment period
	Most patients were extremely or somewhat satisfied with MUCINEX^® in treating their SCB symptoms
	Majority of patients reported improvement in their cough and sputum symptoms, as well as their health-related quality of life
	MUCINEX^® extended-release tablets were well tolerated with minimal adverse events reported and no long-term side effects

Results (interim analysis):^†

Twice daily MUCINEX^®extended-release tablets improved cough and sputum domains‡

In patients with SCB, MUCINEX^® provided:

• effective relief from cough and sputum symptoms
• clinically meaningful change in health-related quality of life

Defined as chronic productive cough for at least 3 months in 2 consecutive years and no acute exacerbations in the previous 4 weeks.
Analysis of 71 patients who completed 6 weekly assessments of the CASA-Q by the interim timepoint of 6 weeks. Further data up to 12 weeks will be published in 2025.
Higher scores indicate fewer or less severe symptoms and less impact.

Reference: Spangenthal S, et al. Presented at 13th International London Cough Symposium, 18–19 July 2024, in press: Journal of Thoracic Disease (JTD).

The FDA defines OTC drugs as medicines it decides are “safe and effective for use without a doctor's prescription.”¹ This open-label, multicenter, single-group study (13th International London Cough Symposium, 2024) evaluated long-term, real-world MUCINEX® use in 71 adults aged 40 or older with stable chronic bronchitis (SCB; chronic productive cough for at least 3 months in 2 consecutive years and no acute exacerbations in the previous 4 weeks). From Week 3, patients took MUCINEX® extended-release (two 600 mg tablets) twice daily for 12 weeks in addition to their other prescribed medications. Interim 6-week data showed high adherence for most patients, most were extremely or somewhat satisfied, the majority reported improved cough, sputum and health-related quality of life, and MUCINEX® was well tolerated with minimal adverse events and no long-term side effects.²