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

Organon

Status and phase: Completed; Phase 4

Conditions: Asthma; Allergic Rhinitis

Treatments: Drug: inhaled corticosteroid; Drug: montelukast sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00442559

0476-367

2007_003

Details and patient eligibility

About

The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.

Enrollment: 191 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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191 participants in 2 patient groups

Montelukast

Experimental group

Description:

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.

Treatment:

Drug: montelukast sodium

Inhaled Corticosteroids (ICS)

Active Comparator group

Description:

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.

Treatment:

Drug: inhaled corticosteroid