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

Asthma Clinical Trial

Official title:

Korean Study of "Real-World" Montelukast Use in Mild Asthmatic Children With Concomitant Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00442559
• Other study ID #: 0476-367
• Secondary ID: 2007_003
• Status: Completed
• Phase: Phase 4
• Start date: January 2005
• Est. completion date: October 2007

Study information

• Verified date: January 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Rhinitis
• Rhinitis, Allergic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline for Daily Allergic Rhinitis Symptom Score	The score is an ordinal scale from 0 (no symptoms) to 3 (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