Phase 4 Completed N=191 Randomized Treatment

Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)

Asthma · Allergic Rhinitis

Source: ClinicalTrials.gov NCT00442559 ↗

Enrolled (actual)

191

Serious AEs

3.7%

Results posted

Nov 2008

Primary outcomePrimary: Change From Baseline for Daytime Asthma Symptom Score — 0.32; 0.16; 0.29; 0.13 Units on scale — p=0.015

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.