Acute Cough Study In Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Common Cold, Infections, Upper Respiratory Tract

Intervention / Treatment
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* Drug: Dextromethorphan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Drug: Dextromethorphan<br>* A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* A single 10 mL dose of matching placebo syrup<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized, parallel, double-blind, placebo-controlled, cough, efficacy, safety, dextromethorphan