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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000634

Enrollment

200

Registered

2007-04-01

Start date

2007-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

pranlukast placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. >= class 2 Ig E RAST to food and/or environmental antigens 2. recurrent wheezes twice in the past

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
occurence of intermittent asthma attack or shift to persistent ashtma	—

Countries

Japan

Contacts

Public ContactMotohiro Ebisawa

National Hospital Organization Clinical Research Center for Allergy and Rheumatology

m-ebisawa@sagamihara-hosp.gr.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026