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Dextromethorphan Pediatric Acute Cough Study (CHPA DXM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02651116
Recruitment Status : Terminated (The study was prematurely discontinued due to slow enrollment during the 2019/2020 cold season. No safety or efficacy concerns led to the decision to terminate)
First Posted : January 8, 2016
Results First Posted : April 28, 2021
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Cough Drug: Dextromethorphan Hydrobromide Drug: Placebo Device: Cough recording device Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 25, 2016
Actual Primary Completion Date : March 19, 2020
Actual Study Completion Date : March 19, 2020


Arm Intervention/treatment
Experimental: Dextromethorphan Hydrobromide
15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide
Drug: Dextromethorphan Hydrobromide
15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide
Other Name: DXM

Device: Cough recording device
FDA approved device validated for use in adults and children
Other Name: VitaloJAK

Placebo Comparator: Placebo
10 mL of Placebo
Drug: Placebo
10 mL Placebo

Device: Cough recording device
FDA approved device validated for use in adults and children
Other Name: VitaloJAK




Primary Outcome Measures :
  1. Mean of Total Cough Counts: Over 24 Hours Post-First Dose on Day 1 [ Time Frame: Over for 24 hours post-first dose on Day 1 ]
    Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated cough counts.


Secondary Outcome Measures :
  1. Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1 [ Time Frame: Between Dose 1 to Dose 2 on Day 1 ]
    Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated cough counts.

  2. Mean of Total Cough Counts: Between Dose 2 on Day 1 to Dose 3 on Day 2 [ Time Frame: Between Dose 2 on Day 1 to Dose 3 on Day 2 (second dose of Day 1 to first dose of Day 2) ]
    Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated cough counts.

  3. Mean of Total Cough Counts: Between Dose 3 to Dose 4 on Day 2 [ Time Frame: Between Dose 3 to Dose 4 on Day 2 (between first and second dose of Day 2) ]
    Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated cough counts.

  4. Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1, and Between Dose 3 to Dose 4 on Day 2 [ Time Frame: Duration between Dose 1 to Dose 2 on Day 1 (between first and second dose of Day 1) plus duration between Dose 3 to Dose 4 on Day 2 (between first and second dose of Day 2) ]
    Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated cough counts. In this outcome measure, as planned combined data is reported for first dosing interval (Dose 1 to Dose 2) on Day 1 and first dosing interval (Dose 3 to Dose 4) on Day 2.

  5. Mean of Total Cough Time Accumulated Over a 24-Hour Period Post-First Dose on Day 1 [ Time Frame: Over for 24 hours post-first dose on Day 1 ]
    Time (in seconds) accumulated over a 24-hour period when cough events occurred was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated total cough time accumulated.


Other Outcome Measures:
  1. Change From Baseline in Morning Cough Frequency Assessed in Morning at Day 2, 3, and 4 [ Time Frame: Baseline (morning screening visit on Day 1); Within 30 minutes of waking, before morning dose on Days 2, 3, and 4 ]
    Participants on specified time points were asked to respond to the following question: "from when you woke up this morning until now, how much have you been coughing", on a 5-point scale: 0= not at all, 1= a tiny bit, 2= a little, 3= some and 4= a lot. Higher scores indicated higher frequency of cough in morning time.

  2. Change From Baseline in Morning Cough Severity Assessed in Morning at Day 2, 3, and 4 [ Time Frame: Baseline (morning screening visit on Day 1); Within 30 minutes of waking, before morning dose on Days 2, 3, and 4 ]
    Participants on specified time points were asked to respond to the following question: "how bad is your cough this morning", on a 5-point scale: 0= no cough, 1= a tiny bit bad, 2= a little bad, 3= bad and 4= very bad. Higher scores indicated more severe cough in morning time.

  3. Change From Baseline in Impact of Cough on Sleep Assessed in Morning at Day 2, 3, and 4 [ Time Frame: Baseline (morning screening visit on Day 1); Within 30 minutes of waking, before morning dose on Days 2, 3, and 4 ]
    Participants on specified time points were asked to respond to the following question: "last night in bed, how much did your cough keep you awake", on a 5-point scale: 0= not at all, 1= a tiny bit, 2= a little, 3= some and 4= a lot. Higher scores indicated worse impact of cough on sleep.

  4. Change From Baseline in Afternoon Cough Frequency Assessed at Afternoon on Day 2, 3, and 4 [ Time Frame: Baseline (afternoon visit on Day 1 before first dose); Before the afternoon dose on Day 2, and 3; Anytime in afternoon of Day 4 ]
    Participants on specified time points were asked to respond to the following question: "how much have you been coughing this afternoon" on a 5-point scale: 0= not at all, 1= a tiny bit, 2= a little, 3= some and 4= a lot. Higher scores indicated higher frequency of cough in afternoon time.

  5. Change From Baseline in Afternoon Cough Severity Assessed at Afternoon on Day 2, 3, and 4 [ Time Frame: Baseline (afternoon visit on Day 1 before first dose); Before the afternoon dose on Day 2, and 3; Anytime in afternoon of Day 4 ]
    Participants on specified time points were asked to respond to the following question: "how bad is your cough this afternoon" on a 5-point scale: 0= no cough, 1= a tiny bit bad, 2= a little bad, 3= bad and 4= very bad. Higher scores indicated more severe cough in afternoon time.

  6. Change From Baseline in Child Global Question Assessed at Afternoon on Day 2, 3, and 4 [ Time Frame: Baseline (afternoon visit on Day 1 before first dose); Before the afternoon dose on Day 2, and 3; Anytime in afternoon of Day 4 ]
    Participants on specified time points were asked to respond to the following question: "how bad is your cold today", on a 5-point scale; 0= no cold, 1= a tiny bit bad, 2= a little bad, 3= bad, and 4= very bad. Higher scores indicated worse cold.

  7. Pediatric Global Assessment of Satisfaction With Study Medication: By Participant, and Caregiver [ Time Frame: For participants: at the end of the study on Day 4; For parents/legally acceptable representatives: within 20 minutes after participant completed assessment at the end of the study on Day 4 ]
    Participants at the end of the study were asked to respond to the following question: "How would you rate the study medication for taking away your cough?" on a 7-point scale: 0= excellent, 1= very good, 2= good, 3= fair, 4= poor, 5= very poor, and 6= terrible. Higher scores indicated poorer satisfaction with study medication. Within 20 minutes after participants completed the assessment parents/legally acceptable representative were asked to respond to the question: "How would you rate the study medication for taking away your child's cough?" on a 7-point scale: 0= excellent, 1= very good, 2= good, 3= fair, 4= poor, 5= very poor, and 6= terrible. Higher scores indicated poorer satisfaction with study medication.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651116


Locations
Show Show 18 study locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] July 18, 2018
Statistical Analysis Plan  [PDF] August 23, 2018

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02651116    
Other Study ID Numbers: A6531002
CHPA DXM ( Other Identifier: Alias Study Number )
First Posted: January 8, 2016    Key Record Dates
Results First Posted: April 28, 2021
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (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
Keywords provided by Pfizer:
cough, acute cough, pediatric, Dextromethorphan Hydrobromide, antitussive, ambulatory cough recording device
Additional relevant MeSH terms:
Layout table for MeSH terms
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs