Title
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
Phase
Phase 4Lead Sponsor
PfizerStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Common Cold Infections, Upper Respiratory TractIntervention/Treatment
dextromethorphan ...Study Participants
14015 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.
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.
A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg)
A single 10 mL dose of matching placebo syrup
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
| Event Type | Organ System | Event Term | Placebo | Dextromethorphan Hydrobromide |
|---|
Total cough count was done by trained assessors using continuous digital video and audio recordings.
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.
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.
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.
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.
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.
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.
