NCT01062256

Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections

A Methodology Study to Assess Cough Counts in Subjects With Acute Upper Respiratory Tract Infections

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are: a) to assess the feasibility and sensitivity of manually count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and severity of acute cough due to upper respiratory tract infection and c) to evaluate the correlation between cough bout frequency and subjective assessments of cough severity. The hypotheses to be tested is that 10 ml of buckwheat honey and 400 mg of immediate release guaifenesin will significantly reduce the frequency and severity of cough compared to placebo over a 4-hour evaluation period.

Conditions

• Infection

Interventions

Type	Name	Description
DRUG	Placebo	One placebo tablet administered orally as a single dose
DRUG	Guaifenesin	One 400 mg immediate release tablet administered orally as a single dose
OTHER	Buckwheat Honey	10 mL administered orally as a single dose

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2010-02-04
• Last updated: 2013-02-25
• Results posted: 2011-03-04

Locations

2 sites across 1 country: United States