Assessment of stable chronic bronchitis improvement with adjunctive long-term MUCINEX® use via the Cough and Sputum Assessment Questionnaire (CASA-Q)

Spangenthal S, et al.

Presented at CHEST Annual Meeting 2025.

Purpose:

To evaluate the long-term use of MUCINEX® in patients with stable chronic bronchitis (SCB)

Methods:

  • Open-label, multicenter, single-cohort study of adults aged ≥40 years with SCB (N=75)
  • 90.7% (n=68) had both SCB and COPD, with chronic bronchitis recognized as a primary form of COPD
  • Patients received MUCINEX® extended-release twice daily (2 x 1200 mg) over a 12-week period, following a 2-week run-in period of no treatment (baseline)
  • From Week 2 onward, patients received MUCINEX® in addition to their other prescribed medications
  • The CASA-Q was self-administered weekly during the treatment period to assess the impact of cough and sputum on patients’ quality of life

Key Findings:

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Sustained improvement in sputum, cough and QoL†

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Minimal clinically important difference (MCID) surpassed by Week 5 across all CASA-Q domains†

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>90% compliance with MUCINEX® maintained each treatment week

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Well tolerated over 12 weeks with no significant drug-related adverse events or treatment discontinuations


Results

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Consistent CASA-Q improvement across all domains† suggests that daily
MUCINEX® use addresses the mucus burden of SCB1

BID=twice daily; COPD=chronic obstructive pulmonary disease; MCID=minimal clinically important difference; QoL=quality of life.

  • Analysis of 75 patients who completed 12 weekly assessments of the CASA-Q by the end of the 12-week treatment period.
  • Higher scores indicate fewer or less severe symptoms and less impact.
  • MCID refers to the smallest change in a patient-reported outcome measure that is considered either beneficial or meaningful for a patient. It helps the doctor recognize that the patient improved in an important way, which can potentially lead to an adjustment in the patient’s treatment plan or a change to patient management.

Reference: Spangenthal S, et al. Assessment of stable chronic bronchitis improvement with adjunctive long-term MUCINEX® use via the cough and sputum assessment questionnaire (CASA-Q). CHEST Annual Meeting 2025 abstract.

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-cohort study evaluated long-term MUCINEX® use in 75 adults aged 40 or older with stable chronic bronchitis (SCB); 90.7% also had COPD. After a 2-week run-in, patients took MUCINEX® extended-release twice daily for 12 weeks in addition to their other prescribed medications and completed the Cough and Sputum Assessment Questionnaire (CASA-Q) weekly. Sputum, cough and quality of life improved in a sustained way, the minimal clinically important difference was surpassed by Week 5 across all CASA-Q domains, compliance stayed above 90% each treatment week, and MUCINEX® was well tolerated.²

Source:

U.S. Food and Drug Administration. Over-the-Counter Medicines: What's Right for You?
https://www.fda.gov/drugs/understanding-over-counter-medicines/over-counter-medicines-whats-right-you

ClinicalTrials.gov. Study NCT05843669.
https://clinicaltrials.gov/study/NCT05843669#study-overview

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