Trial Outcomes & Findings for Montelukast for Early Life Wheezing (NCT NCT00115297)

NCT ID: NCT00115297

Last Updated: 2017-03-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 62 participants
• Primary outcome timeframe: First 56 days of study
• Results posted on: 2017-03-14

Participant Flow

Recruited from University hospital clinics and inpatient services

Specialist physician confirmed new onset wheezing and completion of study data gathering instruments.

Participant milestones

Measure	Monteluksat 5-mg montelukast tablets or 4 mg granules) Montelukast: Participants who are 2 to 3 years old will receive 5-mg montelukast tablets and participants who are 12 months to 2 years old will receive 4-mg montelukast granules.	Placebo Placebo (montelukast tablet or montelukast granules) Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old will receive placebo montelukast granules.
Overall Study STARTED	30	32
Overall Study COMPLETED	30	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Montelukast for Early Life Wheezing

Baseline characteristics by cohort

Measure	Montelukast n=30 Participants 5-mg montelukast tablets or 4 mg granules Montelukast: Participants who are 2 to 3 years old will receive 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules.	Placebo n=32 Participants Placebo (placebo tablets or granules) Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old received placebo montelukast granules.	Total n=62 Participants Total of all reporting groups
Age, Continuous	13 Months n=5 Participants	11.5 Months n=7 Participants	13.0 Months n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	32 Participants n=7 Participants	62 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	32 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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
Region of Enrollment Turkey	30 participants n=5 Participants	32 participants n=7 Participants	62 participants n=5 Participants

PRIMARY outcome

Timeframe: First 56 days of study

Outcome measures

Measure	Montelukast n=30 Participants 5-mg montelukast tablets Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules.	Placebo n=32 Participants Placebo (montelukast tablets) Placebo: Participants who are 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules.
Number of Wheezing-free Days of Infant (Observed by Primary Caregiver)	25.5 Days Interval 10.8 to 37.0	30.5 Days Interval 7.5 to 39.8

SECONDARY outcome

Timeframe: Study day 7

Outcome measures

Measure	Montelukast n=30 Participants 5-mg montelukast tablets Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules.	Placebo n=32 Participants Placebo (montelukast tablets) Placebo: Participants who are 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules.
Wheezing at Day 7	10 participants	22 participants

SECONDARY outcome

Timeframe: Measured during the daytime

Outcome measures

Measure	Montelukast n=30 Participants 5-mg montelukast tablets Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules.	Placebo n=32 Participants Placebo (montelukast tablets) Placebo: Participants who are 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules.
The Number of Participants Requiring Rescue Beta Agonist Use	15 participants	26 participants

Adverse Events

Montelukast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Craig M. Lilly, MD

UMass

Phone: 508-868-5106

Email: craig.lilly@umassmed.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place