UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001635
Receipt number R000001965
Scientific Title Japanese asthma patient's beta2 adrenaline-receptor geno type Arg16Gly cross-over trial about the effect of Salmeterol or Montelukast
Date of disclosure of the study information 2009/01/14
Last modified on 2011/01/14 09:47:04

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Basic information

Public title

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

Acronym

J-BLOSSOM

Scientific Title

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

Scientific Title:Acronym

J-BLOSSOM

Region

Japan


Condition

Condition

Bronchial asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To compare the efficacy and side effects between long-acting beta2-agonist (salmeterol) and leucotrien receptor antagonist (montelukast) as a role of additional drug to an inhaled corticosteroid (ICS) in Japanese patients with bronchial asthma, based on classification of beta2-adrenergic receptor gene pormorphism (Arg16 Gly), in a prospective, randomized, and cross-over design

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

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)

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Salmeterol/Montelukast

Interventions/Control_2

Montelukast/Salmeterol

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key 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.

Key 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.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaharu Nishimura

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Internal Medicine ,Division or Respiratory Medicine

Zip code


Address

North 15, West 7, Kitaku, Sapporo, Hokkaido, 060-8638

TEL

011-706-5911

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hironi Makita

Organization

Institute of Respiratory Cohort Study

Division name

Division of bronchial asthma

Zip code


Address

Kogin Building,North 1, West 5, Kitaku, Sapporo, 060-0001

TEL

011-207-6771

Homepage URL


Email

maki@sa2.so-net.ne.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



Funding Source

Organization

Japan Allergy Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2009 Year 01 Month 14 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2008 Year 01 Month 05 Day

Date of IRB


Anticipated trial start date

2008 Year 03 Month 01 Day

Last follow-up date

2010 Year 11 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 01 Month 14 Day

Last modified on

2011 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001965


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name