Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI

Overview

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

Full Title of Study: “A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Safety and Efficacy of Mucinex D for Symptomatic Therapy in Patients With Acute Upper Respiratory Tract Who Seek Treatment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2010

Interventions

  • Drug: Guaifenesin
    • 1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days
  • Device: Placebo
    • Placebo bid for 7 days

Arms, Groups and Cohorts

  • Active Comparator: Mucinex D
    • Mucinex D (1200 mg guaifenesin and 120 mg pseudoephedrine HCl) extended release bilayer tablet twice a day (bid) with a full glass of water for 7 days
  • Placebo Comparator: Placebo
    • Placebo given bid with a full glass of water for 7 days

Clinical Trial Outcome Measures

Primary Measures

  • Antibiotic Sparing
    • Time Frame: Day 7
    • Number of patients who received an antibiotic
  • Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey – 21 (WURSS-21).
    • Time Frame: Baseline and 7 Days
    • WURSS-21 is made up of 21 questions with a scoring from 0 = no symptom to 7 = severe symptom. With a minimum score of 0 to a maximum score of 147.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Reckitt Benckiser Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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