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

Last updated on December 15, 2017

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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.
Show details

- 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.
Show details

- 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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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
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Infection
  • 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
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Guaifenesin
    Guaifenesin
    Intervention: Drug: Guaifenesin
  • Experimental: Buckwheat Honey
    Buckwheat Honey
    Intervention: Other: Buckwheat Honey
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
265
February 2010
February 2010   (Final data collection date for primary outcome measure)

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.);
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01062256
GG-09-06
B4361001
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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