Trial Outcomes & Findings for Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232) (NCT NCT00943397)
NCT ID: NCT00943397
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
PHASE3
Target enrollment
190 participants
Primary outcome timeframe
Up to 52 weeks of treatment
Results posted on
2022-02-03
Participant Flow
Patients were recruited at 27 sites in Africa, Europe, North America, and South America Therapy period: May 2001 to Mar 2003.
This was an open-label, controlled extended safety study. Patients were treated with either montelukast 4-mg oral granules or usual care. Patients who completed Protocol 176-01 had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol 176-01, could also enroll.
Participant milestones
| Measure |
Usual Care
Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
|
Montelukast
Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
158
|
|
Overall Study
COMPLETED
|
17
|
86
|
|
Overall Study
NOT COMPLETED
|
15
|
72
|
Reasons for withdrawal
| Measure |
Usual Care
Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
|
Montelukast
Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
|
Overall Study
Protocol Violation
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Site terminated and other
|
12
|
56
|
Baseline Characteristics
Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)
Baseline characteristics by cohort
| Measure |
Usual Care
n=32 Participants
Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
|
Montelukast
n=158 Participants
Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.69 Months
STANDARD_DEVIATION 7.22 • n=5 Participants
|
16.45 Months
STANDARD_DEVIATION 7.41 • n=7 Participants
|
16.49 Months
STANDARD_DEVIATION 7.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 52 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 |
Usual Care
n=32 Participants
Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
|
Montelukast
n=158 Participants
Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
|
|---|---|---|
|
Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment
With CAEs
|
31 Participants
|
156 Participants
|
|
Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment
Without CAEs
|
1 Participants
|
2 Participants
|
Adverse Events
Usual Care
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Montelukast
Serious events: 15 serious events
Other events: 155 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=32 participants at risk
Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
|
Montelukast
n=158 participants at risk
Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
|
|---|---|---|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
1.9%
3/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
0.63%
1/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
0.00%
0/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
0.63%
1/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
0.63%
1/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Gastrointestinal disorders
Parotitis
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
0.63%
1/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Respiratory, thoracic and mediastinal disorders
Laryngitis
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
1.3%
2/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
0.63%
1/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
General disorders
Tonsillar Disorder
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
1.3%
2/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
0.63%
1/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Nervous system disorders
Seizure
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
0.63%
1/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
1.9%
3/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
0.63%
1/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Respiratory, thoracic and mediastinal disorders
Laryngotracheitis
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
0.63%
1/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Infections and infestations
Pneumonia
|
0.00%
0/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
1.9%
3/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
Other adverse events
| Measure |
Usual Care
n=32 participants at risk
Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
|
Montelukast
n=158 participants at risk
Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
|
|---|---|---|
|
Infections and infestations
Bacterial Infection
|
6.2%
2/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
2.5%
4/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
General disorders
Fever
|
21.9%
7/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
16.5%
26/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
General disorders
Influenza-Like Disease
|
6.2%
2/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
12.7%
20/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Infections and infestations
Upper Respiratory Infection
|
46.9%
15/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
51.9%
82/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Infections and infestations
Viral Infection
|
28.1%
9/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
10.8%
17/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
8/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
19.0%
30/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Gastrointestinal disorders
Gastroenteritis
|
6.2%
2/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
5.7%
9/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
3/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
6.3%
10/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
3.1%
1/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
12.0%
19/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Eye disorders
Conjunctivitis
|
9.4%
3/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
9.5%
15/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngeal Disorder
|
3.1%
1/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
7.6%
12/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Ear and labyrinth disorders
Otitis
|
9.4%
3/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
0.63%
1/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Ear and labyrinth disorders
Otitis Media
|
21.9%
7/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
24.7%
39/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
43.8%
14/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
36.7%
58/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
9.4%
3/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
11.4%
18/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
6.2%
2/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
7.0%
11/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Infections and infestations
Tonsillitis
|
3.1%
1/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
5.7%
9/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
56.2%
18/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
48.7%
77/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
21.9%
7/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
13.9%
22/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Infections and infestations
Pneumonia
|
3.1%
1/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
5.7%
9/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Infections and infestations
Respiratory Infection
|
3.1%
1/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
5.7%
9/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
6.2%
2/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
0.63%
1/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Infections and infestations
Cutaneous Candidiasis
|
9.4%
3/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
3.8%
6/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Skin and subcutaneous tissue disorders
Eczematous Dermatitis
|
12.5%
4/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
7.6%
12/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
|
Infections and infestations
Varicella
|
9.4%
3/32 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
5.7%
9/158 • Over 52 weeks of treatment and including 14 days follow-up post-treatment AE
|
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