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

• ClinicalTrials.gov Identifier: NCT01062256
• Recruitment Status: Completed
• First Posted: February 4, 2010
• Results First Posted: March 4, 2011
• Last Update Posted: February 25, 2013
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): Wyeth is now a wholly owned subsidiary of Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infection	Drug: Placebo; Drug: Guaifenesin; Other: Buckwheat Honey	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 265 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Methodology Study to Assess Cough Counts in Subjects With Acute Upper Respiratory Tract Infections
• Study Start Date: January 2010
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: February 2010

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo	Drug: Placebo; One placebo tablet administered orally as a single dose
Experimental: Guaifenesin; Guaifenesin	Drug: Guaifenesin; One 400 mg immediate release tablet administered orally as a single dose
Experimental: Buckwheat Honey; Buckwheat Honey	Other: Buckwheat Honey; 10 mL administered orally as a single dose

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.);

Contacts and Locations

Locations

United States, Indiana

Pfizer Investigational Site

Indianapolis, Indiana, United States, 46240

United States, Kentucky

Pfizer Investigational Site

Lexington, Kentucky, United States, 40509

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
• ClinicalTrials.gov Identifier: NCT01062256
• Other Study ID Numbers: GG-09-06; B4361001
• First Posted: February 4, 2010
• Results First Posted: March 4, 2011
• Last Update Posted: February 25, 2013
• Last Verified: February 2013

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Cough assessment in upper respiratory infection; guaifenesin; honey

Additional relevant MeSH terms:

Infections; Communicable Diseases; Respiratory Tract Infections; Disease Attributes; Pathologic Processes; Respiratory Tract Diseases; Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination; Expectorants; Respiratory System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Appetite Depressants; Anti-Obesity Agents; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Nasal Decongestants; Vasoconstrictor Agents