Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI (Wait and See)

Reckitt Benckiser

Status and phase: Completed; Phase 4

Conditions: Acute Upper Respiratory Track Infection

Treatments: Device: Placebo; Drug: Guaifenesin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01202279

2009-MUCD-001

Details and patient eligibility

About

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

Enrollment: 1,179 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,179 participants in 2 patient groups, including a placebo group

Mucinex D

Active Comparator group

Description:

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

Treatment:

Drug: Guaifenesin

Placebo

Placebo Comparator group

Description:

Placebo given bid with a full glass of water for 7 days

Treatment:

Device: Placebo