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

NCT ID: NCT00442559

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2007-10-31

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.

Conditions

Asthma; Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

montelukast sodium

Intervention Type: DRUG

Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months

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.

Group Type: ACTIVE_COMPARATOR

inhaled corticosteroid

Intervention Type: DRUG

Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months

Interventions

montelukast sodium

Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months

Intervention Type: DRUG

inhaled corticosteroid

Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months

Intervention Type: DRUG

Other Intervention Names

Singulair, MK0476

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2007_003

Identifier Type: -

Identifier Source: secondary_id

0476-367

Identifier Type: -

Identifier Source: org_study_id