Conditions: Asthma Allergic Rhinitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 191
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: montelukast sodium intervention 2: inhaled corticosteroid
Intervention descriptions: intervention 1: Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months intervention 2: Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months

Protocol document: