Asthma, Allergic Rhinitis
Conditions
Brief summary
The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.
Interventions
DRUGmontelukast sodium
Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months
Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Between 2 and 14 years old * Diagnosed with asthma, classified as mild persistent asthma according to Global Initiative Asthma Guidelines (GINA) * Diagnosed with comorbid allergic rhinitis
Exclusion criteria
* Patients with suspected sinus infection * Prior treatment with high dose inhaled corticosteroid requiring a dose higher than beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in severe cases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Daytime Asthma Symptom Score | Baseline and Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Daily Allergic Rhinitis Symptom Score | Baseline and Week 12 | 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. |
Participant flow
Recruitment details
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.
Pre-assignment details
Up to 1 week for wash-out - prior to baseline randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 29 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 32 | 34 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Montelukast | Inhaled Corticosteroids (ICS) | Total |
|---|---|---|---|
| Age, Continuous | 5.4 years STANDARD_DEVIATION 3 | 6.1 years STANDARD_DEVIATION 2.6 | 5.8 years STANDARD_DEVIATION 2.8 |
| Allergic rhinitis Mild-intermittent | 14 participants | 17 participants | 31 participants |
| Allergic rhinitis Mild-persistent | 10 participants | 12 participants | 22 participants |
| Daily allergic rhinitis symptom score | 0.45 Units on scale STANDARD_DEVIATION 0.35 | 0.31 Units on scale STANDARD_DEVIATION 0.34 | 0.37 Units on scale STANDARD_DEVIATION 0.35 |
| Daytime asthma symptom score | 0.32 Units on scale STANDARD_DEVIATION 0.42 | 0.29 Units on scale STANDARD_DEVIATION 0.4 | 0.30 Units on scale STANDARD_DEVIATION 0.4 |
| Duration of allergic rhinitis | 0.4 Years STANDARD_DEVIATION 0.6 | 0.8 Years STANDARD_DEVIATION 1 | 0.6 Years STANDARD_DEVIATION 0.9 |
| Duration of asthma | 0.6 Years STANDARD_DEVIATION 0.7 | 1.1 Years STANDARD_DEVIATION 1.2 | 0.9 Years STANDARD_DEVIATION 1.1 |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 19 Participants | 20 Participants | 39 Participants |
| Type of allergic rhinitis Perennial | 11 Participants | 14 Participants | 25 Participants |
| Type of allergic rhinitis Seasonal | 13 Participants | 15 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 83 / 100 | 70 / 91 |
| serious Total, serious adverse events | 4 / 100 | 3 / 91 |
Outcome results
Primary
Change From Baseline for Daytime Asthma Symptom Score
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daytime Asthma Symptom Score at Baseline - Montelukast | Change From Baseline for Daytime Asthma Symptom Score | 0.32 Units on scale | Standard Deviation 0.42 |
| Daytime Asthma Symptom Score at 12 Weeks - Montelukast | Change From Baseline for Daytime Asthma Symptom Score | 0.16 Units on scale | Standard Deviation 0.35 |
| Daytime Asthma Symptom Score at Baseline - ICS | Change From Baseline for Daytime Asthma Symptom Score | 0.29 Units on scale | Standard Deviation 0.4 |
| Daytime Asthma Symptom Score at 12 Weeks - ICS | Change From Baseline for Daytime Asthma Symptom Score | 0.13 Units on scale | Standard Deviation 0.27 |
Comparison: Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.p-value: 0.01595% CI: [-0.29, -0.03]t-test, 2 sided
Comparison: Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daytime asthma symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=29 subjects for the within arm (single arm) comparison between BL and Week 12 scores.p-value: 0.02795% CI: [-0.3, -0.02]t-test, 2 sided
Secondary
Change From Baseline for Daily Allergic Rhinitis Symptom Score
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daytime Asthma Symptom Score at Baseline - Montelukast | Change From Baseline for Daily Allergic Rhinitis Symptom Score | 0.45 Units on scale | Standard Deviation 0.35 |
| Daytime Asthma Symptom Score at 12 Weeks - Montelukast | Change From Baseline for Daily Allergic Rhinitis Symptom Score | 0.23 Units on scale | Standard Deviation 0.26 |
| Daytime Asthma Symptom Score at Baseline - ICS | Change From Baseline for Daily Allergic Rhinitis Symptom Score | 0.31 Units on scale | Standard Deviation 0.34 |
| Daytime Asthma Symptom Score at 12 Weeks - ICS | Change From Baseline for Daily Allergic Rhinitis Symptom Score | 0.19 Units on scale | Standard Deviation 0.26 |
Comparison: Change from BL to Week 12 - Montelukast. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the Montelukast treatment group. Subjects in this analysis: N=24 subjects for the within arm (single arm) comparison between BL and Week 12 scores.p-value: 0.00695% CI: [-0.36, -0.07]t-test, 2 sided
Comparison: Change from BL to Week 12 - ICS. The difference in mean change from baseline to 12 weeks in daily allergic rhinitis symptom score was tested by paired t-test (H0: difference =0) for the ICS treatment group. Subjects in this analysis: N=28 subjects for the within arm (single arm) comparison between BL and Week 12 scores.p-value: 0.03295% CI: [-0.24, -0.01]t-test, 2 sided