Japanese asthma patient's beta2 adrenaline-receptor geno type Arg16Gly cross-over trial about the effect of Salmeterol or Montelukast

UMIN ID: UMIN000001635

Registered date:14/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Bronchial asthma
• Date of first enrollment: 2008/03/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Salmeterol/Montelukast
Montelukast/Salmeterol

Outcome(s)

• Primary Outcome: Comparison of the change in peak flow values over 4 months between the two groups who will be receiving salmeterol plus Inhaled corticosteroid (ICS) and who will be receiving montelukast plus ICS, based on stratification of beta2-adrenergic receptor gene pormorphism (Arg/Arg vs Gly/Gly)
• Secondary Outcome: Comparison of the change in peak flow values between the two groups, (Arg/Arg vs. Gly/Gly) in the period when receiving salmeterol plus ICS Comparison of the change in peak flow values between the two groups, (Arg/Arg vs. Gly/Gly) in the period when receiving montelukast plus ICS The other outcome measurements include asthma control test, peripheral eosinophil count, and pulmonary function parameters

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1 Patients with allergy to Montelukast or Salmeterol 2 Patients with active respiratory infections 3 Pregnant or lactating patients 4 Patients with smoking index 200 or more than 200,or current smokers 5 Patients with other pulmonary complications. 6 Patients judged to be inappropriate by respirologists.

Related Information

• Primary Sponsor: Hokkaido University Graduate School of Medicine Department of Internal Medicine ,Division or Respiratory Medicine
• Source(s) of Monetary Support: Japan Allergy Foundation