Clinical Trial: Dextromethorphan Pediatric Acute Cough Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Placebo-controlled, Double-blind, Randomized, Parallel Group Pilot Study To Evaluate The Efficacy Of Dextromethorphan Hydrobromide On Acute Cough In A Pediatric Populati

Brief Summary: This is a placebo-controlled, double-blind, randomized, parallel group pilot study in approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide (DXM) on acute cough in a pediatric population. Subjects will be otherwise healthy males and females aged 6-11 inclusive who are experiencing acute cough as a symptom of common cold or upper respiratory tract infection. Subjects must have had onset of symptoms within 3 days of screening and qualify based on physical exam and symptom questionnaire. Eligible subjects will be given a single-blind placebo, and fitted with a cough counting device for a 2 hour run-in period. Qualifying subjects will be stratified by age and then randomized to either DXM or placebo in a 1:1 ratio and fitted with the cough recording device for the first 24 hours of treatment. Subjects will receive approximately 9 doses of investigational product over the course of the 4 day study and will complete patient reported outcome questions before the morning and afternoon doses. Subjects will return to the study site on Day 2 to remove the cough recorder and on Day 4 (+ 2 days) to complete the final visit. A review of any reported adverse events will also be completed.

Detailed Summary: This is a placebo-controlled, double-blind, randomized, parallel group pilot study in approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide DXM) on acute cough in a pediatric population. Subjects will be otherwise healthy males and females aged 6-11 inclusive who are experiencing acute cough as a symptom of common cold or upper respiratory tract infection. Subjects must have had onset of symptoms within 3 days of screening and qualify based on physical exam and symptom questionnaire. Eligible subjects will be given a single-blind placebo, and fitted with a cough counting device for a 2 hour run-in period. Qualifying subjects will be stratified by age and then randomized to either DXM or placebo in a 1:1 ratio and fitted with the cough recording device for the first 24 hours of treatment. Subjects will receive approximately 9 doses of investigational product over the course of the 4 day study and will complete patient reported outcome questions before the morning and afternoon doses. Subjects will return to the study site on Day 2 to remove the cough recorder and Day 4 (+2 days) to complete the final visit. A review of any reported adverse events will also be completed. Validated Patient Reported Outcomes (PRO) used in the study include morning cough assessment, afternoon cough assessment, Child Global Question, and Child Cold Symptom Checklist
Sponsor: Pfizer

Current Primary Outcome: total cough count for 24 hours [ Time Frame: Day 1 ]

Original Primary Outcome: total cough count in the first dosing interval on Day 1 [ Time Frame: Day 1 ]

Current Secondary Outcome:

• total cough count for first dosing interval [ Time Frame: Day1 to Day 2 ]
  total cough count collected by the cough recording device during the first dosing interval (Dose 1 to Dose 2) on Day 1
• total cough count overnight [ Time Frame: Day1 to Day 2 ]
  total cough count collected by the cough recording device over the dosing interval from evening dose (Dose 2) on Day 1 to morning dose (Dose 3) on Day 2 (i.e. night time cough count)
• total cough count in the third dosing interval (Day 2) [ Time Frame: Day 2 ]
  total cough count collected by the cough recording device over the first dosing interval on Day 2 (interval between morning dose and afternoon dose on Day 2, ie, Dose 3 to Dose 4)
• change from screening in Patient Reported Outcomes (PRO) response [ Time Frame: Day 1 to 4 ]
  change from screening evaluation (assessed in the morning) in morning cough frequency ("from when you woke up this morning until now, how much have you been coughing"), cough severity ("how bad is your cough this morning"), and impact on sleep ("last night in bed, how much did your cough keep you awake"), assessed by subject
• change from baseline in PRO responses [ Time Frame: Day 1 to 4 ]
  change from baseline evaluation (assessed at afternoon) in afternoon cough frequency ("how much have you been coughing this afternoon") and severity ("how bad is your cough this afternoon") in the afternoon of Days 2-4, assessed by subject
• change from baseline in PRO responses [ Time Frame: Day 1 to Day 4 ]
  change from baseline evaluation (assessed at afternoon) in daily assessment of the cold in the Child Global Question ("how bad is your cold today"), assessed by subject
• subject and caregiver satisfaction with study medication [ Time Frame: Day 1 to Day 4 ]
  subject and parent/legally acceptable representative global assessment of satisfaction with study medication at the end of the study

Original Secondary Outcome:

• total cough count for 24 hours [ Time Frame: Day1 to Day 2 ]
  total cough count collected by the cough recording device during the 24-hour interval post first dose on Day 1
• total cough count overnight [ Time Frame: Day1 to Day 2 ]
  total cough count collected by the cough recording device over the dosing interval from evening dose (Dose 2) on Day 1 to morning dose (Dose 3) on Day 2 (i.e. night time cough count);
• total cough count in the third dosing interval (Day 2) [ Time Frame: Day 2 ]
  total cough count collected by the cough recording device over the first dosing interval on Day 2 (interval between morning dose and afternoon dose on Day 2)
• change from screening in PRO response [ Time Frame: Day 1 to 4 ]
  change from screening evaluation (assessed in the morning) in morning cough frequency ("from when you woke up this morning until now, how much have you been coughing"), cough severity ("how bad is your cough this morning"), and impact on sleep ("last night in bed, how much did your cough keep you awake"), assessed by subject
• change from baseline in PRO responses [ Time Frame: Day 1 to 4 ]
  change from baseline evaluation (assessed at afternoon) in afternoon cough frequency ("how much have you been coughing this afternoon") and severity ("how bad is your cough this afternoon") in the afternoon of Days 2-4, assessed by subject;
• change from basliene in PRO responses [ Time Frame: Day 1 to Day 4 ]
  change from baseline evaluation (assessed at afternoon) in daily assessment of the cold in the child global question ("how bad is your cold today"), assessed by subject;
• subject and caregiver satisfaction with study medication [ Time Frame: Day 1 to Day 4 ]
  subject and parent/legally acceptable representative global assessment of satisfaction with study medication at the end of the study.

Information By: Pfizer

Dates:
Date Received: January 7, 2016
Date Started: February 2016
Date Completion: April 2018
Last Updated: April 21, 2017
Last Verified: April 2017