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

Last updated on February 20, 2019

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Study Location
Pfizer Investigational Site
Indianapolis, Indiana, 46240 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.);

NCT01062256
Pfizer
Completed
Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections

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