Acute Cough Study In Children

• ClinicalTrials.gov Identifier: NCT01257542
• Recruitment Status: Terminated
• First Posted: December 9, 2010
• Results First Posted: September 20, 2012
• Last Update Posted: September 20, 2012
• Sponsor: Pfizer
• Collaborators: AccuDial Pharmaceutical, Inc.; Boehringer Ingelheim; McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.; Novartis; Perrigo Company; Procter and Gamble; Reckitt Benckiser LLC
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.

Condition or disease	Intervention/treatment	Phase
Common Cold; Infections, Upper Respiratory Tract	Drug: Dextromethorphan; Drug: Placebo	Phase 4

Detailed Description:

In light of protocol changes required due to methodological and operational issues, including background noise in cough recordings which could impact data interpretation, the study has been terminated.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Single-Dose, Pilot Study To Evaluate Efficacy Of Dextromethorphan Hydrobromide On Acute Cough In A Pediatric Population
• Study Start Date: December 2010
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active	Drug: Dextromethorphan; A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg)
Placebo Comparator: Placebo	Drug: Placebo; A single 10 mL dose of matching placebo syrup

Outcome Measures

Primary Outcome Measures :

1. Total Cough Count [ Time Frame: Up to 6 hours post-dose ]
   Total cough count was done by trained assessors using continuous digital video and audio recordings.

Secondary Outcome Measures :

1. Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6 hours post-dose ]
   Perceived verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline over the 6-hour post-dosing period calculated as the average of change from baseline [that is (i.e.) baseline value minus the post baseline value] measurements of Hour 1 to Hour 6, thus the change from baseline ranged from -4 to 4; higher score indicated a better improvement.
2. Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6 [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6 hours ]
   Verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline values were derived by subtracting each post baseline value from the baseline value, and ranged from -4 to 4; higher score indicated a better improvement.
3. Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6 hour post-dose ]
   Perceived numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = did not cough at all and 10 = cough a lot. The change from baseline for the 6-hour post-dosing period was calculated as the average of change from baseline (i.e. baseline value minus the post baseline value) measurements of Hour 1 to Hour 6, thus the change from baseline values ranged from -10 to 10; higher score indicated a better improvement.
4. Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6 [ Time Frame: Baseline, 1, 2, 3, 4, 5, 6 hours ]
   Numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", wherein 0 = did not cough at all and 10 = cough a lot. The change from baseline was derived by subtracting the post baseline value from the baseline value and ranged from -10 to 10; higher score indicated a better improvement.
5. Participants' Global Assessment of Cough: Cough Severity [ Time Frame: Within 5 minutes after Hour 6 ]
   Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question " How much have you coughed in the past 6 hours?" where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot.
6. Participants' Global Assessment of Cough: Relief From Cough [ Time Frame: Within 5 minutes after Hour 6 ]
   Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question "From when you woke up this morning until now, how much better is your cough?" where 0 = not at all better, 1 = a tiny bit better, 2 = a little better, 3 = better and 4 = a lot better.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Male or female healthy children ages 6 to under 12 years who are symptomatic with a cough due to a cold or acute URTI characterized by:

• Onset of cold/URTI symptoms occurring no more than 10 days prior to Visit 1;
• At least 5 coughs during the second 30-minute period of the 60-minute baseline period.

General good health, aside from a common cold, and has no contraindications to the study or rescue medication

Exclusion Criteria:

• Acute, subchronic, or chronic cough due to any other condition other than a common cold

History of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, hematological, autoimmune, psychiatric, metabolic, gastro-intestinal or endocrine disease

Contacts and Locations

Locations

United States, Florida

DMI Research

Pinellas, Florida, United States, 33782-4533

United States, Indiana

Concentrics Center for Research

Indianapolis, Indiana, United States, 46240

United States, Oregon

Cyn3rgy Research

Gresham, Oregon, United States, 97030

United States, Tennessee

Clinical Research Associates Incorporated

Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Pfizer

AccuDial Pharmaceutical, Inc.

Boehringer Ingelheim

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Novartis

Perrigo Company

Procter and Gamble

Reckitt Benckiser LLC

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: Pfizer
• ClinicalTrials.gov Identifier: NCT01257542
• Other Study ID Numbers: A6531001; RB-10-12
• First Posted: December 9, 2010
• Results First Posted: September 20, 2012
• Last Update Posted: September 20, 2012
• Last Verified: August 2012

Keywords provided by Pfizer:

randomized; parallel; double-blind; placebo-controlled; cough; efficacy; safety; dextromethorphan

Additional relevant MeSH terms:

Common Cold; Respiratory Tract Infections; Respiratory Tract Diseases; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Dextromethorphan; Antitussive Agents; Respiratory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs