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Completed

NCT Number: NCT01062256

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

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.

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Key information

Conditions

Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pfizer Investigational Site, Indianapolis, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.);

Treatment and study plan

Placebo

Drug

One placebo tablet administered orally as a single dose

Guaifenesin

Drug

One 400 mg immediate release tablet administered orally as a single dose

Buckwheat Honey

Other

10 mL administered orally as a single dose

Primary outcomes

  1. Number of Cough Bouts Over 4-hour Postdose Period

    Time frame: 0 to 4 hours 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 period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.

Secondary outcomes

  1. Number of Cough Bouts Over 2-hour Postdose Period

    Time frame: 0 to 2 hours 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 first 2 hours postdose. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts.

  2. Number of Cough Bouts Within Each 15-minute Time Interval Postdose

    Time frame: every 15 minutes postdose up to 240 minutes 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.

  3. Change From Baseline in Cough Severity Scale

    Time frame: 1, 2, 3, and 4 hours postdose

    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.

  4. Number of Participants With Global Evaluation of Study Medication

    Time frame: 4 hours postdose or early termination

    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

Other outcomes

  1. Number of Participant With Cough Severity

    Time frame: Baseline

    Participant's self-assessment of cough severity using 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). Participants were eligible for study if severity of cough at baseline was at least moderate.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 4, 2010
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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