Clinical trial NCT01062256: Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections
Official title: A Methodology Study to Assess Cough Counts in Subjects With Acute Upper Respiratory Tract Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: Cough assessment in upper respiratory infection
guaifenesin
honey
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-04
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects at least 18 years of age and in generally good health who are experiencing an acute upper respiratory infection of 10 days or less in duration;
* Subjects currently have acute cough self-rated as at least moderate due to an acute Upper Respiratory Infection (URTI) (i.e., cold or flu) as established by a study physician, nurse practitioner, or physician's assistant;
* Subjects who have \> 5 cough bouts during the 30 minute baseline assessment period

Exclusion Criteria:

* Subjects who have acute, subchronic, or chronic cough due to any condition other than a URTI as established by the Investigator, nurse practitioner, or physician's assistant, in accordance with the American College of Chest Physicians (ACCP) Guidelines for Diagnosis and Management of Cough. Special attention should be paid to highly prevalent conditions commonly presenting with cough such as asthma, Chronic Obstructive Pulmonary Disease (COPD), and Gastroesophageal Reflux Disease (GERD) (N.B. Subjects with exercise-induced asthma may be eligible for the study as long as they have not experienced an episode of asthma within 24 hours of enrollment)
* In the opinion of a study physician, nurse practitioner, or physician's assistant, subjects with sinusitis or who have a history of (within the past 2 years) frequent clinically significant sinusitis;
* Subjects with a history (within the last 3 years) of alcohol abuse (i.e., consuming greater than or equal to 3 alcoholic drinks/day on a regular basis) or substance abuse (i.e., ingesting/smoking marijuana more than once a week at any time during the past 6 months or using any other recreational drug more than once during the past 6 months). (Note: One "drink" of alcohol=1 oz. liquor, 6 oz wine, 12 oz. beer.);

Primary outcomes:
measure: Number of Cough Bouts Over 4-hour Postdose Period
timeFrame: 0 to 4 hours postdose
Secondary outcomes:
measure: Number of Cough Bouts Over 2-hour Postdose Period
timeFrame: 0 to 2 hours postdose
measure: Number of Cough Bouts Within Each 15-minute Time Interval Postdose
timeFrame: every 15 minutes postdose up to 240 minutes postdose
measure: Change From Baseline in Cough Severity Scale
timeFrame: 1, 2, 3, and 4 hours postdose
measure: Number of Participants With Global Evaluation of Study Medication
timeFrame: 4 hours postdose or early termination
Other outcomes:
measure: Number of Participant With Cough Severity
timeFrame: Baseline
Locations:
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: