Montelukast Use in Mild Asthmatic Children with Allergic Rhinitis

• Conditions: mild asthma and allergic rhinitis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-004748-37-Outside-EU/EEA
• Lead Sponsor: MSD Korea LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-03
• Last Update Posted: 13 April 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

a. Patients’ caregiver understands the study procedures and agrees to
participate by signing the appropriate informed consent form.
b. Patient is a male or female and between the ages of 2 and 14 years
(inclusive) at Visit 1.
c. Patients diagnosed with asthma, classified as mild persistent asthma
according to GINA guidelines at the time of inclusion.
d. Patients diagnosed with comorbid allergic rhinitis.

Are the trial subjects under 18? yes
Number of subjects for this age range: 191
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. Prior treatment with high dose ICS (i.e., requires a dose higher than beclomethasone dipropionate 400 µg per day, or equivalent), other medications used in severe cases.
b. Patients with suspected rhino-sinusitis (i.e., fetid breathing, mucopurulent nasal discharge, post nasal drip, X-ray finding etc.)
c. Patients with cystic fibrosis, congenital heart disease.
d. Patients with Chinese medication use at inclusion.
e. Inappropriate patients with investigator judgment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified