Trial Outcomes & Findings for Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176) (NCT NCT00943683)
NCT ID: NCT00943683
Last Updated: 2022-02-03
Results Overview
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
256 participants
Primary outcome timeframe
During the 6 weeks of treatment
Results posted on
2022-02-03
Participant Flow
Patients were recruited at 65 study centers in Africa, Asia, Europe, North America, and South America Therapy period: Aug 2000 to Feb 2001
Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit. Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines
Participant milestones
| Measure |
Placebo
Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
|
Montelukast
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
175
|
|
Overall Study
COMPLETED
|
74
|
169
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
Placebo
Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
|
Montelukast
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Patient Moved
|
1
|
0
|
Baseline Characteristics
Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)
Baseline characteristics by cohort
| Measure |
Placebo
n=81 Participants
Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
|
Montelukast
n=175 Participants
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.05 Months
STANDARD_DEVIATION 5.22 • n=93 Participants
|
14.90 Months
STANDARD_DEVIATION 4.70 • n=4 Participants
|
14.63 Months
STANDARD_DEVIATION 4.87 • n=27 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=93 Participants
|
116 Participants
n=4 Participants
|
175 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: During the 6 weeks of treatmentPopulation: All patients who took study medication were included in the analysis.
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Outcome measures
| Measure |
Placebo
n=81 Participants
Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
|
Montelukast
n=175 Participants
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
|
|---|---|---|
|
Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment
With CAEs
|
62 Participants
|
132 Participants
|
|
Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment
Without CAEs
|
19 Participants
|
43 Participants
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Montelukast
Serious events: 7 serious events
Other events: 112 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=81 participants at risk
Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
|
Montelukast
n=175 participants at risk
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/81 • During the 6 weeks of treatment and including 14 days following treatment
|
0.57%
1/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Injury, poisoning and procedural complications
Drug Overdose
|
0.00%
0/81 • During the 6 weeks of treatment and including 14 days following treatment
|
0.57%
1/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Musculoskeletal and connective tissue disorders
Inguinal Hernia
|
0.00%
0/81 • During the 6 weeks of treatment and including 14 days following treatment
|
0.57%
1/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/81 • During the 6 weeks of treatment and including 14 days following treatment
|
0.57%
1/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration (Condition)
|
0.00%
0/81 • During the 6 weeks of treatment and including 14 days following treatment
|
0.57%
1/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/81 • During the 6 weeks of treatment and including 14 days following treatment
|
0.57%
1/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis
|
1.2%
1/81 • During the 6 weeks of treatment and including 14 days following treatment
|
0.00%
0/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Infections and infestations
Pneumonia
|
0.00%
0/81 • During the 6 weeks of treatment and including 14 days following treatment
|
0.57%
1/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/81 • During the 6 weeks of treatment and including 14 days following treatment
|
0.57%
1/175 • During the 6 weeks of treatment and including 14 days following treatment
|
Other adverse events
| Measure |
Placebo
n=81 participants at risk
Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
|
Montelukast
n=175 participants at risk
Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
|
|---|---|---|
|
General disorders
Fever
|
13.6%
11/81 • During the 6 weeks of treatment and including 14 days following treatment
|
13.1%
23/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Infections and infestations
Upper Respiratory Infection
|
21.0%
17/81 • During the 6 weeks of treatment and including 14 days following treatment
|
32.0%
56/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Gastrointestinal disorders
Diarrhea
|
12.3%
10/81 • During the 6 weeks of treatment and including 14 days following treatment
|
10.3%
18/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
9/81 • During the 6 weeks of treatment and including 14 days following treatment
|
8.6%
15/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Eye disorders
Conjunctivitis
|
6.2%
5/81 • During the 6 weeks of treatment and including 14 days following treatment
|
2.3%
4/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Ear and labyrinth disorders
Otitis Media
|
6.2%
5/81 • During the 6 weeks of treatment and including 14 days following treatment
|
8.6%
15/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
7.4%
6/81 • During the 6 weeks of treatment and including 14 days following treatment
|
8.0%
14/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
22.2%
18/81 • During the 6 weeks of treatment and including 14 days following treatment
|
18.3%
32/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
6.2%
5/81 • During the 6 weeks of treatment and including 14 days following treatment
|
4.0%
7/175 • During the 6 weeks of treatment and including 14 days following treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
5/81 • During the 6 weeks of treatment and including 14 days following treatment
|
5.1%
9/175 • During the 6 weeks of treatment and including 14 days following treatment
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER