Efficacy of JPGL-based controller therapy with montelukast for early mild asthma

UMIN ID: UMIN000002219

Registered date:19/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Bronchial asthma
• Date of first enrollment: 2009/08/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Montelukast + on demand use of beta2 agonists
on demand use of beta2 agonists

Outcome(s)

• Primary Outcome: Number of asthma exacerbation episodes
• Secondary Outcome: 1) Time to first asthma exacerbation 2) Time to loss of asthma control that needs inhaled corticosteroids 3) Symptom-free days

Key inclusion & exclusion criteria

• Age minimum: 1years-old
• Age maximum: 6years-old
• Gender: Male and Female
• Exclude criteria: 1 use of anti-allergics within 6 months before enrollment (cromolyns, anti-histamines, suplatast, montelukast, pranlukast) 2 use of inhaled and systemic corticosteroids within 6 months before enrollment 3 use of theophylline within 6 months before enrollment 4 hypersensitivity to montelukast 5 use of long-acting beta2 agonists within 6 months before enrollment (permit short-term use of tuloburol patch) 6 conditions that a responsible investigator judges inapproriate

Related Information

• Primary Sponsor: Le-PAT study group
• Secondary Sponsor: The Waksman Foundation of Japan, INC
• Source(s) of Monetary Support: The Waksman Foundation of Japan, INC,The Waksman Foundation of Japan, INC