You are here

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

Last updated on December 12, 2019

FOR MORE INFORMATION
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Descriptive Information
Brief Title  ICMJE Study of Count Coughs in Subjects With Acute Upper Respiratory Tract Infections
Official Title  ICMJE A Methodology Study to Assess Cough Counts in Subjects With Acute Upper Respiratory Tract Infections
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Guaifenesin
    Guaifenesin
    Intervention: Drug: Guaifenesin
  • Experimental: Buckwheat Honey
    Buckwheat Honey
    Intervention: Other: Buckwheat Honey
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2010)
265
Original Estimated Enrollment  ICMJE
 (submitted: February 2, 2010)
250
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.);
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01062256
Other Study ID Numbers  ICMJE GG-09-06
B4361001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now