Randomized, controlled trial of early intervention with pranlukast for prevention of bronchial asthma in infants with wheezy bronchitis and atopy

UMIN ID: UMIN000000634

Registered date:01/04/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Infants between 1 and 3 years old, who have severe atopy defined by class 2 and more of Ig E to food and/or environment allergens and history of wheezy bronchitis twice.
• Date of first enrollment: 2007/04/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

pranlukast
placebo

Outcome(s)

• Primary Outcome: occurence of intermittent asthma attack or shift to persistent ashtma

Key inclusion & exclusion criteria

• Age minimum: 1years-old
• Age maximum: 3years-old
• Gender: Male and Female
• Exclude criteria: 1. Diagnosed as bronchial asthma and treated with anti-inflammation drugs. 2. Treated with Pranlukast continuously in the past. 3. Treated with anti-histaminics (including anti-allergic drugs) for more than 6 months in the past.

Related Information

• Primary Sponsor: Japanese Society of Pediatric Allergy and Clinical Immunology
• Source(s) of Monetary Support: Japan Allergy Foundation