NIPH Clinical Trials Search

UMIN ID: UMIN000001635

Registered date:14/01/2009

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedBronchial asthma
Date of first enrollment2008/03/01
Target sample size100
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Salmeterol/Montelukast Montelukast/Salmeterol


Primary OutcomeComparison 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 OutcomeComparison 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 minimum20years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteria1 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


public contact
Name Hironi Makita
Address Kogin Building,North 1, West 5, Kitaku, Sapporo, 060-0001 Japan
Telephone 011-207-6771
Affiliation Institute of Respiratory Cohort Study Division of bronchial asthma
scientific contact
Name Masaharu Nishimura
Address North 15, West 7, Kitaku, Sapporo, Hokkaido, 060-8638 Japan
Telephone 011-706-5911
Affiliation Hokkaido University Graduate School of Medicine Department of Internal Medicine ,Division or Respiratory Medicine