Acute Cough Study In Children

Phase 4

Terminated

• Conditions: Common Cold; Infections, Upper Respiratory Tract
• Interventions: Drug: Dextromethorphan; Drug: Placebo

• Registration Number: NCT01257542
• Lead Sponsor: Pfizer

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.

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 Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Disposition First Submitted: 2012-02-15
• Disposition First Submitted QC: 2012-02-28
• Disposition First Posted: 2012-03-01
• Status Verified: 2012-08
• Results First Submitted: 2012-08-21
• Results First Submitted QC: 2012-08-21
• Last Update Submitted: 2012-08-21
• Results First Posted: 2012-09-20
• Last Update Posted: 2012-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Dextromethorphan	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period	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	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	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	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	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	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.

Trial Locations

Locations (4)

DMI Research; 🇺🇸 Pinellas, Florida, United States

Cyn3rgy Research; 🇺🇸 Gresham, Oregon, United States

Clinical Research Associates Incorporated; 🇺🇸 Nashville, Tennessee, United States

Concentrics Center for Research; 🇺🇸 Indianapolis, Indiana, United States