Acute Cough Study In Children

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2011

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.

Interventions

  • 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)
  • Drug: Placebo
    • A single 10 mL dose of matching placebo syrup

Arms, Groups and Cohorts

  • Experimental: Active
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 11 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Collaborator
    • AccuDial Pharmaceutical, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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