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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infection

Intervention / Treatment
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* Drug: Placebo
* Drug: Guaifenesin
* Other: Buckwheat Honey


Participation Criteria
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Eligibility Criteria
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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.);

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* One placebo tablet administered orally as a single dose<br>|
| Experimental: Guaifenesin<br>Guaifenesin | Drug: Guaifenesin<br>* One 400 mg immediate release tablet administered orally as a single dose<br>|
| Experimental: Buckwheat Honey<br>Buckwheat Honey | Other: Buckwheat Honey<br>* 10 mL administered orally as a single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cough Bouts Over 4-hour Postdose Period | Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts. | 0 to 4 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cough Bouts Over 2-hour Postdose Period | Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during first 2 hours postdose. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts. | 0 to 2 hours postdose | 
| Number of Cough Bouts Within Each 15-minute Time Interval Postdose | Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour (240-minute) period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts in 15 minute intervals. | every 15 minutes postdose up to 240 minutes postdose | 
| Change From Baseline in Cough Severity Scale | Participant's self-assessment of cough severity using a 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Change from baseline derived by subtracting post baseline cough severity from baseline cough severity. Change from baseline values could have ranged from -1.0 to 3.0 with higher values indicative of greater improvement. | 1, 2, 3, and 4 hours postdose | 
| Number of Participants With Global Evaluation of Study Medication | Participant-rated evaluation of study product; Participants responded to the following question: How would you rate this product as a cough reliever? 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent | 4 hours postdose or early termination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cough assessment in upper respiratory infection, guaifenesin, honey