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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001635
Enrollment
100
Registered
2009-01-14
Start date
2008-03-01
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

Bronchial asthma

Interventions

Salmeterol/Montelukast Montelukast/Salmeterol

Sponsors

Hokkaido University Graduate School of Medicine Department of Internal Medicine ,Division or Respiratory Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with symptoms such as paroxymal cough or wheezing or dyspnea Patients with the reversibility of forced expiratory volume in 1 second or airway hyperresponsiveness or patients in an equivalent state judged by respirologists. Clinically stable patients taking inhaled corticosteroids with/without theophylline.

Exclusion criteria

Exclusion 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.

Design outcomes

Secondary

MeasureTime frame
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

Primary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactHironi Makita

Institute of Respiratory Cohort Study Division of bronchial asthma

maki@sa2.so-net.ne.jp011-207-6771

Outcome results

None listed

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