Trial Outcomes & Findings for Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367) (NCT NCT00442559)
NCT ID: NCT00442559
Last Updated: 2024-05-13
Results Overview
The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
191 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2024-05-13
Participant Flow
Conducted at 5 sites in Korea, Jan2005\~ Oct2007 in pediatric participants with comorbid mild asthma and allergic rhinitis. Participant's caregiver understands the study procedures and agrees to participate, signing the informed consent form.
Up to 1 week for wash-out - prior to baseline randomization.
Participant milestones
| Measure |
Montelukast
Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
Inhaled Corticosteroids (ICS)
Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
91
|
|
Overall Study
12 Weeks After Randomization
|
68
|
60
|
|
Overall Study
COMPLETED
|
66
|
56
|
|
Overall Study
NOT COMPLETED
|
34
|
35
|
Reasons for withdrawal
| Measure |
Montelukast
Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
Inhaled Corticosteroids (ICS)
Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
32
|
34
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)
Baseline characteristics by cohort
| Measure |
Montelukast
n=24 Participants
Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
Inhaled Corticosteroids (ICS)
n=29 Participants
Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.4 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
6.1 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
5.8 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Allergic rhinitis
Mild-intermittent
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Allergic rhinitis
Mild-persistent
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Type of allergic rhinitis
Seasonal
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Type of allergic rhinitis
Perennial
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Daily allergic rhinitis symptom score
|
0.45 Units on scale
STANDARD_DEVIATION 0.35 • n=5 Participants
|
0.31 Units on scale
STANDARD_DEVIATION 0.34 • n=7 Participants
|
0.37 Units on scale
STANDARD_DEVIATION 0.35 • n=5 Participants
|
|
Daytime asthma symptom score
|
0.32 Units on scale
STANDARD_DEVIATION 0.42 • n=5 Participants
|
0.29 Units on scale
STANDARD_DEVIATION 0.40 • n=7 Participants
|
0.30 Units on scale
STANDARD_DEVIATION 0.40 • n=5 Participants
|
|
Duration of allergic rhinitis
|
0.4 Years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
0.8 Years
STANDARD_DEVIATION 1 • n=7 Participants
|
0.6 Years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Duration of asthma
|
0.6 Years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
1.1 Years
STANDARD_DEVIATION 1.2 • n=7 Participants
|
0.9 Years
STANDARD_DEVIATION 1.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.
The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.
Outcome measures
| Measure |
Daytime Asthma Symptom Score at Baseline - Montelukast
n=24 Participants
Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
Daytime Asthma Symptom Score at 12 Weeks - Montelukast
n=24 Participants
Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
Daytime Asthma Symptom Score at Baseline - ICS
n=29 Participants
Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
Daytime Asthma Symptom Score at 12 Weeks - ICS
n=29 Participants
Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline for Daytime Asthma Symptom Score
|
0.32 Units on scale
Standard Deviation 0.42 • Interval -0.29 to -0.03
|
0.16 Units on scale
Standard Deviation 0.35 • Interval -0.3 to -0.02
|
0.29 Units on scale
Standard Deviation 0.4
|
0.13 Units on scale
Standard Deviation 0.27
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: The secondary efficacy parameter was a mean change from baseline to treatment for daily allergic rhinitis symptom score. Therefore 139 participants who didn't have a daily allergic rhinitis symptom score from the participant diary were not included.
The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.
Outcome measures
| Measure |
Daytime Asthma Symptom Score at Baseline - Montelukast
n=24 Participants
Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
Daytime Asthma Symptom Score at 12 Weeks - Montelukast
n=24 Participants
Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
Daytime Asthma Symptom Score at Baseline - ICS
n=28 Participants
Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
Daytime Asthma Symptom Score at 12 Weeks - ICS
n=28 Participants
Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
|---|---|---|---|---|
|
Change From Baseline for Daily Allergic Rhinitis Symptom Score
|
0.45 Units on scale
Standard Deviation 0.35 • Interval -0.36 to -0.07
|
0.23 Units on scale
Standard Deviation 0.26 • Interval -0.24 to -0.01
|
0.31 Units on scale
Standard Deviation 0.34
|
0.19 Units on scale
Standard Deviation 0.26
|
Adverse Events
Montelukast
Serious events: 4 serious events
Other events: 83 other events
Deaths: 0 deaths
Inhaled Corticosteroids (ICS)
Serious events: 3 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Montelukast
n=100 participants at risk
Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
Inhaled Corticosteroids (ICS)
n=91 participants at risk
Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/100 • Up to 12 months
|
1.1%
1/91 • Number of events 1 • Up to 12 months
|
|
General disorders
PYREXIA
|
0.00%
0/100 • Up to 12 months
|
1.1%
1/91 • Number of events 1 • Up to 12 months
|
|
Infections and infestations
CHRONIC SINUSITIS
|
0.00%
0/100 • Up to 12 months
|
1.1%
1/91 • Number of events 1 • Up to 12 months
|
|
Infections and infestations
PNEUMONIA
|
1.0%
1/100 • Number of events 1 • Up to 12 months
|
1.1%
1/91 • Number of events 1 • Up to 12 months
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/100 • Up to 12 months
|
1.1%
1/91 • Number of events 1 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
3.0%
3/100 • Number of events 3 • Up to 12 months
|
2.2%
2/91 • Number of events 2 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.0%
1/100 • Number of events 1 • Up to 12 months
|
0.00%
0/91 • Up to 12 months
|
Other adverse events
| Measure |
Montelukast
n=100 participants at risk
Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
Inhaled Corticosteroids (ICS)
n=91 participants at risk
Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
VOMITING
|
6.0%
6/100 • Number of events 6 • Up to 12 months
|
7.7%
7/91 • Number of events 7 • Up to 12 months
|
|
General disorders
PYREXIA
|
31.0%
31/100 • Number of events 41 • Up to 12 months
|
26.4%
24/91 • Number of events 34 • Up to 12 months
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.0%
6/100 • Number of events 6 • Up to 12 months
|
2.2%
2/91 • Number of events 2 • Up to 12 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
9.0%
9/100 • Number of events 9 • Up to 12 months
|
7.7%
7/91 • Number of events 10 • Up to 12 months
|
|
Nervous system disorders
HEADACHE
|
9.0%
9/100 • Number of events 9 • Up to 12 months
|
11.0%
10/91 • Number of events 11 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
56.0%
56/100 • Number of events 88 • Up to 12 months
|
51.6%
47/91 • Number of events 92 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
7.0%
7/100 • Number of events 10 • Up to 12 months
|
5.5%
5/91 • Number of events 6 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DISCOMFORT
|
15.0%
15/100 • Number of events 21 • Up to 12 months
|
8.8%
8/91 • Number of events 9 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
7.0%
7/100 • Number of events 8 • Up to 12 months
|
8.8%
8/91 • Number of events 10 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
12.0%
12/100 • Number of events 12 • Up to 12 months
|
13.2%
12/91 • Number of events 17 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
27.0%
27/100 • Number of events 36 • Up to 12 months
|
23.1%
21/91 • Number of events 30 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
21.0%
21/100 • Number of events 29 • Up to 12 months
|
19.8%
18/91 • Number of events 26 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
UPPER AIRWAY OBSTRUCTION
|
30.0%
30/100 • Number of events 42 • Up to 12 months
|
33.0%
30/91 • Number of events 43 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
9.0%
9/100 • Number of events 10 • Up to 12 months
|
14.3%
13/91 • Number of events 15 • Up to 12 months
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
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