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

Phase 4CompletedNCT01202279

Reckitt Benckiser Inc.1,179 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,179

Conditions

Acute Upper Respiratory Track Infection

Interventions

GuaifenesinDRUG

1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days

PlaceboDEVICE

Placebo bid for 7 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (24)

Outcomes

Primary Outcomes

Antibiotic Sparing

Number of patients who received an antibiotic

Time frame: Day 7

Change From Baseline in Total Symptom Score of the Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21).

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.

Time frame: Baseline and 7 Days

Data from ClinicalTrials.gov

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