Phase 4
N=191
Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)
Asthma · Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00442559 ↗Enrolled (actual)
191
Serious AEs
3.7%
Results posted
Nov 2008
Primary outcome: Primary: Change From Baseline for Daytime Asthma Symptom Score — 0.32; 0.16; 0.29; 0.13 Units on scale — p=0.015
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- montelukast sodium (Drug); inhaled corticosteroid (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline for Daytime Asthma Symptom Score |
0.32; 0.16; 0.29; 0.13 | 0.015 sig |
| SECONDARY Change From Baseline for Daily Allergic Rhinitis Symptom Score |
0.45; 0.23; 0.31; 0.19 | 0.006 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00442559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.