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

NCT01062256 | Completed Results

• 2 other identifiers: GG-09-06B4361001
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 2

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.

Conditions

Infection

Keywords

Cough assessment in upper respiratory infection; guaifenesin; honey

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Cough Bouts Over 2-hour Postdose Period

  0 to 2 hours postdose

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

  every 15 minutes postdose up to 240 minutes postdose

• Change From Baseline in Cough Severity Scale

  1, 2, 3, and 4 hours postdose

• Number of Participants With Global Evaluation of Study Medication

  4 hours postdose or early termination

Other Outcomes (1)

• Number of Participant With Cough Severity

  Baseline

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Guaifenesin

EXPERIMENTAL

Guaifenesin

Drug: Guaifenesin

Buckwheat Honey

EXPERIMENTAL

Buckwheat Honey

Other: Buckwheat Honey

Interventions

Placebo DRUG

One placebo tablet administered orally as a single dose

Placebo

Guaifenesin DRUG

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

Guaifenesin

Buckwheat Honey OTHER

10 mL administered orally as a single dose

Buckwheat Honey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.);

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Indianapolis, Indiana, 46240, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40509, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Infections

Interventions

Guaifenesin

Intervention Hierarchy (Ancestors)

Guaiacol; Methyl Ethers; Ethers; Organic Chemicals; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Pfizer Clinical Trials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquires@Pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 4, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 25, 2013
• Results First Posted: March 4, 2011

Record last verified: 2013-02

Locations

US (2)