NCT02651116: CHPA DXM

Dextromethorphan Pediatric Acute Cough Study

Terminated Phase 4 Results posted Last updated 28 April 2021

What this trial tests

Phase 4 trial testing Dextromethorphan Hydrobromide in Cough in 131 participants. Terminated before completion.

Timeline

25 February 2016

Primary endpoint
19 March 2020

19 March 2020

Quick facts

Lead sponsor	Pfizer
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	131
Start date	25 February 2016
Primary completion	19 March 2020
Estimated completion	19 March 2020
Sites	18 locations across United States

Drugs / interventions tested

• Dextromethorphan Hydrobromide — full drug profile →
• Placebo
• Cough recording device

Conditions studied

• Cough — all drugs for Cough →

Sponsor

Pfizer — full company profile →

Who can join

Adults 6 to 11, any sex, with Cough. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean of Total Cough Counts: Over 24 Hours Post-First Dose on Day 1 Primary · 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.

Group	Value	95% CI
Dextromethorphan Hydrobromide	457.1	± 367.21
Placebo	676.8	± 814.33

Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1 Secondary · 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.

Group	Value	95% CI
Dextromethorphan Hydrobromide	32.73	± 30.597
Placebo	47.03	± 57.729

Mean of Total Cough Counts: Between Dose 2 on Day 1 to Dose 3 on Day 2 Secondary · 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.

Group	Value	95% CI
Dextromethorphan Hydrobromide	9.70	± 8.877
Placebo	11.44	± 13.193

Mean of Total Cough Counts: Between Dose 3 to Dose 4 on Day 2 Secondary · 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.

Group	Value	95% CI
Dextromethorphan Hydrobromide	19.32	± 16.752
Placebo	33.62	± 47.709

Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1, and Between Dose 3 to Dose 4 on Day 2 Secondary · 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

Group	Value	95% CI
Dextromethorphan Hydrobromide	26.13	± 21.498
Placebo	40.39	± 49.896

Mean of Total Cough Time Accumulated Over a 24-Hour Period Post-First Dose on Day 1 Secondary · 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.

Group	Value	95% CI
Dextromethorphan Hydrobromide	350.5	± 268.95
Placebo	502.7	± 566.57

Change From Baseline in Morning Cough Frequency Assessed in Morning at Day 2, 3, and 4 Secondary · 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.

Baseline

Group	Value	95% CI
Dextromethorphan Hydrobromide	3.4	± 0.65
Placebo	3.3	± 0.63

Change at Day 2

Group	Value	95% CI
Dextromethorphan Hydrobromide	-1.2	± 1.30
Placebo	-0.7	± 1.15

Change at Day 3

Group	Value	95% CI
Dextromethorphan Hydrobromide	-1.5	± 1.15
Placebo	-1.1	± 1.38

Change at Day 4

Group	Value	95% CI
Dextromethorphan Hydrobromide	-2.0	± 1.20
Placebo	-1.8	± 1.40

Change From Baseline in Morning Cough Severity Assessed in Morning at Day 2, 3, and 4 Secondary · 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.

Baseline

Group	Value	95% CI
Dextromethorphan Hydrobromide	3.1	± 0.54
Placebo	3.1	± 0.60

Change at Day 2

Group	Value	95% CI
Dextromethorphan Hydrobromide	-1.1	± 0.89
Placebo	-0.6	± 1.19

Change at Day 3

Group	Value	95% CI
Dextromethorphan Hydrobromide	-1.4	± 0.96
Placebo	-1.3	± 1.22

Change at Day 4

Group	Value	95% CI
Dextromethorphan Hydrobromide	-1.9	± 1.10
Placebo	-1.8	± 1.15

Change From Baseline in Impact of Cough on Sleep Assessed in Morning at Day 2, 3, and 4 Secondary · 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.

Baseline

Group	Value	95% CI
Dextromethorphan Hydrobromide	2.8	± 1.15
Placebo	3.0	± 1.19

Change at Day 2

Group	Value	95% CI
Dextromethorphan Hydrobromide	-0.8	± 1.56
Placebo	-0.7	± 1.45

Change at Day 3

Group	Value	95% CI
Dextromethorphan Hydrobromide	-1.3	± 1.59
Placebo	-1.4	± 1.67

Change at Day 4

Group	Value	95% CI
Dextromethorphan Hydrobromide	-1.8	± 1.57
Placebo	-1.9	± 1.74

Change From Baseline in Afternoon Cough Frequency Assessed at Afternoon on Day 2, 3, and 4 Secondary · 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.

Baseline

Group	Value	95% CI
Dextromethorphan Hydrobromide	3.2	± 0.80
Placebo	3.4	± 0.73

Change at Day 2

Group	Value	95% CI
Dextromethorphan Hydrobromide	-0.7	± 1.25
Placebo	-0.6	± 1.06

Change at Day 3

Group	Value	95% CI
Dextromethorphan Hydrobromide	-1.5	± 1.30
Placebo	-1.4	± 1.27

Change at Day 4

Group	Value	95% CI
Dextromethorphan Hydrobromide	-1.9	± 1.22
Placebo	-1.8	± 1.41

Change From Baseline in Afternoon Cough Severity Assessed at Afternoon on Day 2, 3, and 4 Secondary · 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.

Baseline

Group	Value	95% CI
Dextromethorphan Hydrobromide	2.8	± 0.83
Placebo	3.1	± 0.84

Change at Day 2

Group	Value	95% CI
Dextromethorphan Hydrobromide	-0.7	± 1.16
Placebo	-0.6	± 0.98

Change at Day 3

Group	Value	95% CI
Dextromethorphan Hydrobromide	-1.4	± 1.15
Placebo	-1.4	± 1.24

Change at Day 4

Group	Value	95% CI
Dextromethorphan Hydrobromide	-1.7	± 1.08
Placebo	-1.6	± 1.45

Change From Baseline in Child Global Question Assessed at Afternoon on Day 2, 3, and 4 Secondary · 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.

Baseline

Group	Value	95% CI
Dextromethorphan Hydrobromide	3.2	± 0.42
Placebo	3.3	± 0.46

Change at Day 2

Group	Value	95% CI
Dextromethorphan Hydrobromide	-1.1	± 1.02
Placebo	-0.9	± 1.01

Change at Day 3

Group	Value	95% CI
Dextromethorphan Hydrobromide	-1.6	± 0.93
Placebo	-1.6	± 1.13

Change at Day 4

Group	Value	95% CI
Dextromethorphan Hydrobromide	-2.1	± 0.87
Placebo	-1.7	± 1.26

Adverse events — posted to ClinicalTrials.gov

Time frame: Day 1 up to 14 days after last dose of study medication (up to 18 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dextromethorphan Hydrobromide

Serious: 0/68 (0%)

Deaths: 0/68

Placebo

Serious: 0/63 (0%)

Deaths: 0/63

Other adverse events (30 terms — click to expand)

Reaction	System	Dextromethorphan Hydrobrom…	Placebo
Headache	Nervous system disorders	—	—
Nasal turbinate abnormality	Respiratory, thoracic and mediastinal disorders	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—
Otitis media	Infections and infestations	—	—
Dennie-Morgan fold	Skin and subcutaneous tissue disorders	—	—
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—
Tympanic membrane hyperaemia	Ear and labyrinth disorders	—	—
Lip dry	Gastrointestinal disorders	—	—
Malaise	General disorders	—	—
Pain	General disorders	—	—
Bronchiolitis	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Nasopharyngitis	Infections and infestations	—	—
Otitis media acute	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Viral infection	Infections and infestations	—	—
Joint injury	Injury, poisoning and procedural complications	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—
Photosensitivity reaction	Skin and subcutaneous tissue disorders	—	—
Psychomotor hyperactivity	Nervous system disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Nasal dryness	Respiratory, thoracic and mediastinal disorders	—	—
Nasal mucosal disorder	Respiratory, thoracic and mediastinal disorders	—	—
Nasal oedema	Respiratory, thoracic and mediastinal disorders	—	—
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—
Rhonchi	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT02651116 adverse events section.

Sponsor's own 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 on Day 4 (+ 2 days) to complete the final visit. A review of any reported adverse events will also be completed.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.