Trial Outcomes & Findings for Dextromethorphan Pediatric Acute Cough Study (NCT NCT02651116)

NCT ID: NCT02651116

Last Updated: 2021-04-28

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 131 participants
• Primary outcome timeframe: Over for 24 hours post-first dose on Day 1
• Results posted on: 2021-04-28

Participant Flow

Study was conducted in the United States from 25 February 2016 to 19 March 2020.

There was a run-in period of 2 hours where participants were administered 10 milliliter (mL) of non-medicinal liquid oral confection for once, and fitted with cough counting device VitaloJAKTM. Eligible participants who completed run-in period, were qualified for randomization to either dextromethorphan hydrobromide (DXM HBr) or placebo in a 4 day treatment period.

Participant milestones

Measure	Dextromethorphan Hydrobromide Participants were randomized to receive 9 doses of DXM HBr (15 milligram \[mg\] per 10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Overall Study STARTED	68	63
Overall Study Treated	68	63
Overall Study COMPLETED	67	62
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Dextromethorphan Hydrobromide Participants were randomized to receive 9 doses of DXM HBr (15 milligram \[mg\] per 10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Overall Study Adverse Event	0	1
Overall Study No Longer Willing To Participate In Study	1	0

Baseline Characteristics

Dextromethorphan Pediatric Acute Cough Study

Baseline characteristics by cohort

Measure	Dextromethorphan Hydrobromide n=68 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=63 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Total n=131 Participants Total of all reporting groups
Age, Continuous	8.3 Years STANDARD_DEVIATION 1.57 • n=5 Participants	8.0 Years STANDARD_DEVIATION 1.73 • n=7 Participants	8.2 Years STANDARD_DEVIATION 1.65 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	32 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants	56 Participants n=7 Participants	120 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Over for 24 hours post-first dose on Day 1

Population: The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data.

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.

Outcome measures

Measure	Dextromethorphan Hydrobromide n=67 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=61 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Mean of Total Cough Counts: Over 24 Hours Post-First Dose on Day 1	457.1 cough counts Standard Deviation 367.21 • Interval 367.21 to	676.8 cough counts Standard Deviation 814.33 • Interval 814.33 to

SECONDARY outcome

Timeframe: Between Dose 1 to Dose 2 on Day 1

Population: The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Dextromethorphan Hydrobromide n=66 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=61 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1	32.73 cough counts Standard Deviation 30.597 • Interval 30.597 to	47.03 cough counts Standard Deviation 57.729 • Interval 57.729 to

SECONDARY outcome

Timeframe: Between Dose 2 on Day 1 to Dose 3 on Day 2 (second dose of Day 1 to first dose of Day 2)

Population: The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Dextromethorphan Hydrobromide n=65 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=61 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Mean of Total Cough Counts: Between Dose 2 on Day 1 to Dose 3 on Day 2	9.70 cough counts Standard Deviation 8.877 • Interval 8.877 to	11.44 cough counts Standard Deviation 13.193 • Interval 13.193 to

SECONDARY outcome

Timeframe: Between Dose 3 to Dose 4 on Day 2 (between first and second dose of Day 2)

Population: The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Dextromethorphan Hydrobromide n=65 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=60 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Mean of Total Cough Counts: Between Dose 3 to Dose 4 on Day 2	19.32 cough counts Standard Deviation 16.752 • Interval 16.752 to	33.62 cough counts Standard Deviation 47.709 • Interval 47.709 to

SECONDARY outcome

Timeframe: 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)

Population: The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Dextromethorphan Hydrobromide n=66 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=61 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1, and Between Dose 3 to Dose 4 on Day 2	26.13 cough counts Standard Deviation 21.498 • Interval 21.498 to	40.39 cough counts Standard Deviation 49.896 • Interval 49.896 to

SECONDARY outcome

Timeframe: Over for 24 hours post-first dose on Day 1

Population: The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data.

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.

Outcome measures

Measure	Dextromethorphan Hydrobromide n=67 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=61 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Mean of Total Cough Time Accumulated Over a 24-Hour Period Post-First Dose on Day 1	350.5 seconds Standard Deviation 268.95 • Interval 268.95 to	502.7 seconds Standard Deviation 566.57 • Interval 566.57 to

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (morning screening visit on Day 1); Within 30 minutes of waking, before morning dose on Days 2, 3, and 4

Population: The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here 'number analyzed' signifies participants with available data for each specified category.

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.

Outcome measures

Measure	Dextromethorphan Hydrobromide n=67 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=61 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Change From Baseline in Morning Cough Frequency Assessed in Morning at Day 2, 3, and 4 Baseline	3.4 units on a scale Standard Deviation 0.65	3.3 units on a scale Standard Deviation 0.63
Change From Baseline in Morning Cough Frequency Assessed in Morning at Day 2, 3, and 4 Change at Day 2	-1.2 units on a scale Standard Deviation 1.30	-0.7 units on a scale Standard Deviation 1.15
Change From Baseline in Morning Cough Frequency Assessed in Morning at Day 2, 3, and 4 Change at Day 3	-1.5 units on a scale Standard Deviation 1.15	-1.1 units on a scale Standard Deviation 1.38
Change From Baseline in Morning Cough Frequency Assessed in Morning at Day 2, 3, and 4 Change at Day 4	-2.0 units on a scale Standard Deviation 1.20	-1.8 units on a scale Standard Deviation 1.40

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (morning screening visit on Day 1); Within 30 minutes of waking, before morning dose on Days 2, 3, and 4

Population: The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here 'number analyzed' signifies participants with available data for each specified category.

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.

Outcome measures

Measure	Dextromethorphan Hydrobromide n=67 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=61 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Change From Baseline in Morning Cough Severity Assessed in Morning at Day 2, 3, and 4 Baseline	3.1 units on a scale Standard Deviation 0.54	3.1 units on a scale Standard Deviation 0.60
Change From Baseline in Morning Cough Severity Assessed in Morning at Day 2, 3, and 4 Change at Day 2	-1.1 units on a scale Standard Deviation 0.89	-0.6 units on a scale Standard Deviation 1.19
Change From Baseline in Morning Cough Severity Assessed in Morning at Day 2, 3, and 4 Change at Day 3	-1.4 units on a scale Standard Deviation 0.96	-1.3 units on a scale Standard Deviation 1.22
Change From Baseline in Morning Cough Severity Assessed in Morning at Day 2, 3, and 4 Change at Day 4	-1.9 units on a scale Standard Deviation 1.10	-1.8 units on a scale Standard Deviation 1.15

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (morning screening visit on Day 1); Within 30 minutes of waking, before morning dose on Days 2, 3, and 4

Population: The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here 'number analyzed' signifies participants with available data for each specified category.

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.

Outcome measures

Measure	Dextromethorphan Hydrobromide n=67 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=61 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Change From Baseline in Impact of Cough on Sleep Assessed in Morning at Day 2, 3, and 4 Baseline	2.8 units on a scale Standard Deviation 1.15	3.0 units on a scale Standard Deviation 1.19
Change From Baseline in Impact of Cough on Sleep Assessed in Morning at Day 2, 3, and 4 Change at Day 2	-0.8 units on a scale Standard Deviation 1.56	-0.7 units on a scale Standard Deviation 1.45
Change From Baseline in Impact of Cough on Sleep Assessed in Morning at Day 2, 3, and 4 Change at Day 3	-1.3 units on a scale Standard Deviation 1.59	-1.4 units on a scale Standard Deviation 1.67
Change From Baseline in Impact of Cough on Sleep Assessed in Morning at Day 2, 3, and 4 Change at Day 4	-1.8 units on a scale Standard Deviation 1.57	-1.9 units on a scale Standard Deviation 1.74

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (afternoon visit on Day 1 before first dose); Before the afternoon dose on Day 2, and 3; Anytime in afternoon of Day 4

Population: The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here 'number analyzed' signifies participants with available data for each specified category.

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.

Outcome measures

Measure	Dextromethorphan Hydrobromide n=67 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=61 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Change From Baseline in Afternoon Cough Frequency Assessed at Afternoon on Day 2, 3, and 4 Baseline	3.2 units on a scale Standard Deviation 0.80	3.4 units on a scale Standard Deviation 0.73
Change From Baseline in Afternoon Cough Frequency Assessed at Afternoon on Day 2, 3, and 4 Change at Day 2	-0.7 units on a scale Standard Deviation 1.25	-0.6 units on a scale Standard Deviation 1.06
Change From Baseline in Afternoon Cough Frequency Assessed at Afternoon on Day 2, 3, and 4 Change at Day 3	-1.5 units on a scale Standard Deviation 1.30	-1.4 units on a scale Standard Deviation 1.27
Change From Baseline in Afternoon Cough Frequency Assessed at Afternoon on Day 2, 3, and 4 Change at Day 4	-1.9 units on a scale Standard Deviation 1.22	-1.8 units on a scale Standard Deviation 1.41

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (afternoon visit on Day 1 before first dose); Before the afternoon dose on Day 2, and 3; Anytime in afternoon of Day 4

Population: The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here 'number analyzed' signifies participants with available data for each specified category.

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.

Outcome measures

Measure	Dextromethorphan Hydrobromide n=67 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=61 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Change From Baseline in Afternoon Cough Severity Assessed at Afternoon on Day 2, 3, and 4 Baseline	2.8 units on a scale Standard Deviation 0.83	3.1 units on a scale Standard Deviation 0.84
Change From Baseline in Afternoon Cough Severity Assessed at Afternoon on Day 2, 3, and 4 Change at Day 2	-0.7 units on a scale Standard Deviation 1.16	-0.6 units on a scale Standard Deviation 0.98
Change From Baseline in Afternoon Cough Severity Assessed at Afternoon on Day 2, 3, and 4 Change at Day 3	-1.4 units on a scale Standard Deviation 1.15	-1.4 units on a scale Standard Deviation 1.24
Change From Baseline in Afternoon Cough Severity Assessed at Afternoon on Day 2, 3, and 4 Change at Day 4	-1.7 units on a scale Standard Deviation 1.08	-1.6 units on a scale Standard Deviation 1.45

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (afternoon visit on Day 1 before first dose); Before the afternoon dose on Day 2, and 3; Anytime in afternoon of Day 4

Population: The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here 'number analyzed' signifies participants with available data for each specified category.

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.

Outcome measures

Measure	Dextromethorphan Hydrobromide n=67 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=61 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Change From Baseline in Child Global Question Assessed at Afternoon on Day 2, 3, and 4 Baseline	3.2 units on a scale Standard Deviation 0.42	3.3 units on a scale Standard Deviation 0.46
Change From Baseline in Child Global Question Assessed at Afternoon on Day 2, 3, and 4 Change at Day 2	-1.1 units on a scale Standard Deviation 1.02	-0.9 units on a scale Standard Deviation 1.01
Change From Baseline in Child Global Question Assessed at Afternoon on Day 2, 3, and 4 Change at Day 3	-1.6 units on a scale Standard Deviation 0.93	-1.6 units on a scale Standard Deviation 1.13
Change From Baseline in Child Global Question Assessed at Afternoon on Day 2, 3, and 4 Change at Day 4	-2.1 units on a scale Standard Deviation 0.87	-1.7 units on a scale Standard Deviation 1.26

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Population: The full analysis set included all participants who were randomized, took Dose 1, had a valid baseline cough count assessment, and provided any post-dosing efficacy data. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.

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.

Outcome measures

Measure	Dextromethorphan Hydrobromide n=66 Participants Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=61 Participants Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Pediatric Global Assessment of Satisfaction With Study Medication: By Participant, and Caregiver By Participant:	1.7 units on a scale Standard Deviation 1.20	1.6 units on a scale Standard Deviation 1.26
Pediatric Global Assessment of Satisfaction With Study Medication: By Participant, and Caregiver By Caregiver:	1.8 units on a scale Standard Deviation 1.07	1.9 units on a scale Standard Deviation 1.16

Adverse Events

Dextromethorphan Hydrobromide

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Dextromethorphan Hydrobromide n=68 participants at risk Participants were randomized to receive 9 doses of DXM HBr (15 mg/10 mL) over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of DXM HBr syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of DXM HBr syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of DXM HBr syrup in morning. Participants were followed up for 14 days after last dose of study medication.	Placebo n=63 participants at risk Participants were randomized to receive 9 doses of placebo matched to 15 mg/10 mL DXM HBr over the course of 4 day study treatment and were fitted with the cough recording device VitaloJAKTM for the first 24 hours of treatment. On Day 1, participants received a single 10 mL oral dose of placebo syrup each in afternoon and evening. On Day 2 and 3, participants received a single 10 mL oral dose of placebo syrup each in morning, afternoon and evening. On Day 4, participants received a single 10 mL oral dose of placebo syrup in morning. Participants were followed up for 14 days after last dose of study medication.
Blood and lymphatic system disorders Lymphadenopathy	1.5% 1/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Ear and labyrinth disorders Tympanic membrane hyperaemia	1.5% 1/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	0.00% 0/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Gastrointestinal disorders Lip dry	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
General disorders Malaise	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
General disorders Pain	1.5% 1/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	0.00% 0/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Infections and infestations Bronchiolitis	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Infections and infestations Influenza	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Infections and infestations Nasopharyngitis	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Infections and infestations Otitis media	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	3.2% 2/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Infections and infestations Otitis media acute	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Infections and infestations Urinary tract infection	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Infections and infestations Viral infection	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Injury, poisoning and procedural complications Joint injury	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Nervous system disorders Headache	1.5% 1/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	4.8% 3/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Skin and subcutaneous tissue disorders Dennie-Morgan fold	2.9% 2/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	0.00% 0/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Skin and subcutaneous tissue disorders Photosensitivity reaction	1.5% 1/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	0.00% 0/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Nervous system disorders Psychomotor hyperactivity	1.5% 1/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	0.00% 0/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Respiratory, thoracic and mediastinal disorders Cough	1.5% 1/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Respiratory, thoracic and mediastinal disorders Nasal oedema	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Respiratory, thoracic and mediastinal disorders Nasal turbinate abnormality	4.4% 3/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	1.5% 1/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	1.6% 1/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.5% 1/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	0.00% 0/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.9% 2/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	4.8% 3/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Respiratory, thoracic and mediastinal disorders Rhonchi	1.5% 1/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	0.00% 0/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/68 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.	3.2% 2/63 • Day 1 up to 14 days after last dose of study medication (up to 18 days) Same event may appear as Adverse Event and Serious Adverse Events, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety was evaluated on all participants who received the study drug.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER