Acute Cough Study In Children

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

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.

Study Overview

• Status: Terminated
• Conditions: Common Cold; Infections, Upper Respiratory Tract
• Intervention / Treatment: Drug: Dextromethorphan; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Pinellas, Florida, United States, 33782-4533
      • DMI Research
  • Indiana
    • Indianapolis, Indiana, United States, 46240
      • Concentrics Center for Research
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Cyn3rgy Research
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; A single 10 mL dose of matching placebo syrup
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Cough Count	Total cough count was done by trained assessors using continuous digital video and audio recordings.	Up to 6 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period	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.	Baseline, 1, 2, 3, 4, 5, 6 hours post-dose
Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6	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.	Baseline, 1, 2, 3, 4, 5, 6 hours
Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period	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.	Baseline, 1, 2, 3, 4, 5, 6 hour post-dose
Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6	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.	Baseline, 1, 2, 3, 4, 5, 6 hours
Participants' Global Assessment of Cough: Cough Severity	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.	Within 5 minutes after Hour 6
Participants' Global Assessment of Cough: Relief From Cough	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.	Within 5 minutes after Hour 6

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Novartis; Boehringer Ingelheim; Reckitt Benckiser LLC; Procter and Gamble; Perrigo Company; McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.; AccuDial Pharmaceutical, Inc.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: December 7, 2010
• First Submitted That Met QC Criteria: December 8, 2010
• First Posted (ESTIMATE): December 9, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 20, 2012
• Last Update Submitted That Met QC Criteria: August 21, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: safety; efficacy; cough; randomized; placebo-controlled; double-blind; dextromethorphan; parallel
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Picornaviridae Infections; Respiratory Tract Infections; Common Cold; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Respiratory System Agents; Antitussive Agents; Dextromethorphan
• Other Study ID Numbers: A6531001; RB-10-12