Trial Outcomes & Findings for Trial of Montelukast for Treatment of Acute Bronchiolitis (NCT NCT00863317)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

141 participants

Primary outcome timeframe

up to 4 weeks

Results posted on

2015-07-15

Participant milestones
Measure	Montelukast 4mg granules montelukast sodium: 4mg granules daily for 14 days	Placebo sucrose: table sugar as placebo daily for 14 days
Overall Study STARTED	68	73
Overall Study COMPLETED	60	64
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal
Measure	Montelukast 4mg granules montelukast sodium: 4mg granules daily for 14 days	Placebo sucrose: table sugar as placebo daily for 14 days
Overall Study Lost to Follow-up	8	9

Trial of Montelukast for Treatment of Acute Bronchiolitis

Baseline characteristics by cohort
Measure	Montelukast n=60 Participants 4mg granules montelukast sodium: 4mg granules daily for 14 days	Sucrose n=64 Participants sucrose: table sugar as placebo daily for 14 days	Total n=124 Participants Total of all reporting groups
Age, Categorical <=18 years	60 Participants n=5 Participants	64 Participants n=7 Participants	124 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	35 Participants n=7 Participants	67 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	64 participants n=7 Participants	124 participants n=5 Participants

Timeframe: up to 4 weeks

Outcome measures
Measure	Montelukast n=60 Participants 4mg granules montelukast sodium: 4mg granules daily for 14 days	Placebo n=64 Participants sucrose: table sugar as placebo daily for 14 days
Duration of Cough	13 days Interval 1.0 to 45.0	11 days Interval 2.0 to 63.0

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Montelukast n=68 participants at risk 4mg granules montelukast sodium: 4mg granules daily for 14 days	Placebo n=73 participants at risk sucrose: table sugar as placebo daily for 14 days
Gastrointestinal disorders Vomiting	5.9% 4/68 • Number of events 4 • 4 weeks Assessment was made via weekly follow up telephone interviews	4.1% 3/73 • Number of events 3 • 4 weeks Assessment was made via weekly follow up telephone interviews
Gastrointestinal disorders Diarrhea	4.4% 3/68 • Number of events 3 • 4 weeks Assessment was made via weekly follow up telephone interviews	2.7% 2/73 • Number of events 2 • 4 weeks Assessment was made via weekly follow up telephone interviews

Richmond Emergency Physicians Inc

Phone: 773 447-2489