Phase 4
N=1,179
Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI
Acute Upper Respiratory Track Infection
Bottom Line
View on ClinicalTrials.gov: NCT01202279 ↗Enrolled (actual)
1,179
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Antibiotic Sparing — 89; 121 Participants — p=0.025
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Guaifenesin (Drug); Placebo (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Reckitt Benckiser Inc.
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibiotic Sparing |
89; 121 | 0.025 sig |
| PRIMARY Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21). |
-14.2; -13.4 | 0.022 sig |
Summary
The purpose of this study is to determine if treatment with Mucinex D lowers the use of antibiotics in the treatment of upper respiratory infection when compared to placebo
Eligibility Criteria
Inclusion Criteria
- patients aged 18 to 75 yrs of age presenting at a clinical site with symptoms diagnostic for an acute upper respiratory tract infection within the last 5 days
Exclusion Criteria
- patients who had chronic, recurring respiratory signs and symptoms due to conditions such as chronic allergic rhinitis, chronic sinusitis or chronic bronchitis which in the investigator's opinion, confounded interpretation of symptom ratings for the acute upper respiratory infection. Also excluded were patients with a fever greater than 101 degrees F.
Data sourced from ClinicalTrials.gov (NCT01202279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.