Dextromethorphan Pediatric Acute Cough Study (CHPA DXM)

• ClinicalTrials.gov Identifier: NCT02651116
• Recruitment Status: Terminated
• First Posted: January 8, 2016
• Last Update Posted: October 20, 2020
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: January 7, 2016
• First Posted Date: January 8, 2016
• Last Update Posted Date: October 20, 2020
• Actual Study Start Date: February 25, 2016
• Actual Primary Completion Date: March 19, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 17, 2016)

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

total cough count collected by the cough recording device in an ambulatory setting over a 24-hour interval post-first dose on Day 1

Original Primary Outcome Measures (submitted: January 7, 2016)

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

total cough count collected by the cough recording device in an ambulatory setting over the first dosing interval on Day 1

Current Secondary Outcome Measures (submitted: August 21, 2018)

• 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
• total cough count for first dosing interval (Day 1) and third dosing interval (Day 2) [ Time Frame: Day 1 to Day 2 ]
  total cough count collected by the cough recording device over the first dosing interval on Day 1 (Dose 1 to Dose 2) and the first dosing interval on Day 2 (Dose 3 to Dose 4). These 2 dose intervals approximately represent the daytime cough count.
• time accumulated over a 24-hour period when cough events occurred [ Time Frame: Day 1 to Day 2 ]
  time accumulated over a 24-hour period when cough events occurred

Original Secondary Outcome Measures (submitted: January 7, 2016)

• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dextromethorphan Pediatric Acute Cough Study
• 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 POPULATION
• 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 Description: 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
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Cough

Intervention

• Drug: Dextromethorphan Hydrobromide
  15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide
  Other Name: DXM
• Drug: Placebo
  10 mL Placebo
• Device: Cough recording device
  FDA approved device validated for use in adults and children
  Other Name: VitaloJAK

Study Arms

• Experimental: Dextromethorphan Hydrobromide
  15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide
  Interventions:

  • Drug: Dextromethorphan Hydrobromide
  • Device: Cough recording device
• Placebo Comparator: Placebo
  10 mL of Placebo
  Interventions:

  • Drug: Placebo
  • Device: Cough recording device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 17, 2020): 131
• Original Estimated Enrollment (submitted: January 7, 2016): 150
• Actual Study Completion Date: March 19, 2020
• Actual Primary Completion Date: March 19, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Generally healthy male or female children/adolescents ages 6 to 11 years, inclusive.
• Subject has an acute cough and other symptoms consistent with a common cold/acute upper respiratory tract infection (URTI) diagnosis as deemed by the investigator or qualified designee based on findings from medical history review, full physical examination and vital signs.
• The onset of symptoms must be no more than 3 days prior to Visit 1, as determined by the subject or parent/legally acceptable representative.
• Qualifying response on the Child Cold Symptom Checklist.
• Parent/legally acceptable representative, and subject agrees the subject will not use any other cough or cold treatments during the study.

Exclusion Criteria:

• A subchronic, or chronic cough due to any condition other than an URTI or common cold as established by the investigator, nurse practitioner, or physician's assistant, in accordance with the American College of Chest Physicians' (ACCP) Guidelines for Diagnosis and Management of Cough. Special attention should be paid to highly prevalent conditions commonly presenting with cough such as asthma, rhinitis, or gastroesophageal reflux disease (GERD).
• Symptoms of runny nose, stuffy nose, sore throat, or sneezing due to any condition other than URTI or common cold (eg, seasonal or perennial allergic rhinitis, sinusitis, strep throat, vasomotor rhinitis, etc.) as established by the investigator.
• An acute cough that occurs with excessive phlegm (mucus) or is chronic such as occurs with smoking, asthma, bronchitis, allergies, or a gastroesophageal condition (eg, acid reflux and GERD) or history of such a cough.
• Clinical features of a complication of the common cold during the physical examination at screening (eg, otitis media, sinusitis, or pneumonia) with or without the need for systematic antibiotics.
• Pneumonia (active or with a symptom-free period of <30 days), asthma (active or with a symptom-free period of <1 year), or other significant pulmonary diseases.
• Fever greater than 39ºC (102ºF oral temperature) at the time of screening if, in the judgment of the investigator, the individual is too ill to participate in the study or the fever is due to reasons other than URTI.
• Signs of dehydration (as may be due to vomiting, diarrhea, or lack of fluid intake) during the physical examination at screening.
• Diabetes or hypoglycemic disorders.
• Known contraindications to the investigational product or acetaminophen (APAP).
• Sitting blood pressure reading at or above the limits as documented in the protocol.
• Obstructive sleep apnea caused by enlarged tonsils and adenoids, low muscle tone, or allergies.
• History of known or suspected allergy or hypersensitivity to dextromethorphan (DXM) or APAP, or any of the non medicinal ingredients contained in the single-blind confection, double-blind investigational products, or APAP.
• History of taking any of the specified prohibited medications or products within the corresponding washout periods prior to taking the first dose of investigational product.
• History of taking a medication that is sedating within the past 24 hours prior to screening (eg sedatives, hypnotics, tranquilizers, anticonvulsants, benzodiazepines, and clonidine).
• Subject has a sibling contemporaneously participating in this study.

Randomization Criteria:

• Subjects must complete the 2 hour ambulatory cough counting baseline run-in recording period and must return to the study site for randomization at least 2 hours after the recording started.
• Subjects whose equipment failed, preventing collection of cough count data for at least 2 hours during the Baseline Run-in Period, or those who took off the device during this period will be excluded from further study participation.
• Subjects who do not return to the study site (before 3:30 pm) in time for the afternoon dose will not be randomized.
• Qualifying response on Child Global Question

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 11 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02651116
• Other Study ID Numbers: A6531002; CHPA DXM ( Other Identifier: Alias Study Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: October 2020