A real-world, open-label, multicenter, single-group study to evaluate patient's reactions to MUCINEX®

W. W. Storms, M. A. Kaliner, M. Javidi, J. R. Farrar, C. S. Efessiou

J Allergy Clin Immunol 119(1): S229, 2007

Purpose:

To assess the efficacy of 12-hr MUCINEX^® for mucus-related respiratory conditions

Methods:

• Open-label, multicenter, single-group trial
• N=791 patients, ages 14 to 92 completed the interview
• 87 physicians enrolled patients with upper or lower respiratory conditions, including chest congestion, sinusitis, nasal congestion, rhinitis, bronchitis, asthma, and congestion (non-specific)
• Patient enrollment questionnaire evaluated pre-treatment respiratory symptoms and medication usage
• Patients treated 7 days with two 600 mg guaifenesin tablets BID plus usual care

Key Findings:

Patients rated how they felt as good to excellent (8-10)

All patients; scale for overall feeling: 0 = poor to 10 = excellent

Adapted from Storms WW, et al. A real-world, open-label, multicenter, single-group study to evaluate patients’ reactions to MUCINEX^®. J Allergy Clin Immunol 119(1): S229, 2007.

• Patients consistently improved; the mean score increased from 5.23 (enrollment) to 7.91 (day 7, P ≤ 0.05)
• The mean score for each day differed significantly from every other day (P ≤ 0.05), with a statistically significant trend across days (Regression analysis: r=0.31; P ≤ 0.05)
• Regression analysis indicated an average improvement of 0.36 per day across the 7 days

Results:

One week’s treatment of respiratory illnesses with MUCINEX^® significantly improved mucus-related symptoms and overall feelings of health

• >93% of patients took MUCINEX^® as directed
• >91% reported that MUCINEX^® helped their condition
• 83% reported that MUCINEX^® helped them “return to normal” faster
• Significant improvements (P ≤ 0.05) observed by day 2
• All patients improved within a few days
• Adverse events were recorded independently

This real-world, open-label study asked 791 patients (ages 14 to 92) how they felt after 7 days of MUCINEX® (two 600 mg tablets BID) plus usual care. Overall feeling scores rose from 5.23 at enrollment to 7.91 by day 7, with significant improvement seen by day 2, and one week of MUCINEX® significantly improved mucus-related symptoms.