This is 9 month, placebo-controlled, double blind, randomised trial using the oral
leucotrienes receptor antagonist montelukast (5 mg) in 160 children with mild and moderate
asthma age 6-14 year old, sensitive to house dust mite. There are two study groups:
montelukast group 80 patients and placebo group 80 patients. All patients will receive
budesonide in dose sufficient to control asthma symptoms and short-acting beta agonist as
needed. Medication used in the study: montelukast 5mg, budesonide. There are 7 doctor's
visits - one initial visit (June) and 6 follow-up visits. First visit is on the first day of
asthma symptom and each follow-up visit is every 6 weeks. Children with full asthma control
(as measured by exhaled NO) had administered 100 mcg lower dose of budesonide and children
with not fully control asthma had administered 100 mcg higher dose of budesonide.
Phase:
Phase 3
Details
Lead Sponsor:
Medical University of Lodz Medical Universtity of Lodz