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

NCT00442559 | Completed Phase 4 Results

• 2 other identifiers: 0476-3672007_003
• Study Type: interventional
• Target: 191
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline for Daytime Asthma Symptom Score

  The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.

  Baseline and Week 12

Secondary Outcomes (1)

• Change From Baseline for Daily Allergic Rhinitis Symptom Score

  Baseline and Week 12

Study Arms (2)

Montelukast

EXPERIMENTAL

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.

Drug: montelukast sodium

Inhaled Corticosteroids (ICS)

ACTIVE COMPARATOR

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.

Drug: inhaled corticosteroid

Interventions

montelukast sodium DRUG

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

Also known as: Singulair, MK0476

Montelukast

inhaled corticosteroid DRUG

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

Inhaled Corticosteroids (ICS)

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Limitations and Caveats

This was an open-label study. Only 53 patients had diary information with daytime asthma symptom score - thus, 138 cases were dropped from analysis due to lack of daytime asthma symptom score.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2007
• First Posted: March 2, 2007
• Study Start: January 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: May 13, 2024
• Results First Posted: November 18, 2008

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share