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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000724
Receipt No. R000000866
Scientific Title Research study of QOL with leukotriene receptor antagonist ,pranlukast in asthmatic patients by use of Asthma Health Questionnaire-Japan QOL (AHQ-JAPAN QOL)
Date of disclosure of the study information 2007/06/01
Last modified on 2007/05/25

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Basic information
Public title Research study of QOL with leukotriene receptor antagonist ,pranlukast in asthmatic patients by use of Asthma Health Questionnaire-Japan QOL
(AHQ-JAPAN QOL)
Acronym Asthma QOL Research Study by use of
Asthma Health Questionnaire-Japan QOL (AHQ-JAPAN QOL)
Scientific Title Research study of QOL with leukotriene receptor antagonist ,pranlukast in asthmatic patients by use of Asthma Health Questionnaire-Japan QOL
(AHQ-JAPAN QOL)
Scientific Title:Acronym Asthma QOL Research Study by use of
Asthma Health Questionnaire-Japan QOL (AHQ-JAPAN QOL)
Region
Japan

Condition
Condition Asthma
Classification by specialty
Medicine in general Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of Pranlukast in the improvementof of QOL with asthmatic patients and the usefulness of Asthma Health Questionnaire-Japan QOL (AHQ-JAPAN QOL).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes QOL Questionnaire of asthmatic patients by use of AHQ-JAPAN QOL and AQLQ.
Key secondary outcomes Pulmonary functions test((PEF,FVC and FEV)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pranlukast
2 tablets x 2 / day (112.5mg/tablet)
8 weeks
Interventions/Control_2
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Asthmatic patients with mild-to-severe asthma (as defined by the Japanese Society of Allergology) that were not well controlled by daily treatment.
Key exclusion criteria Asthmatic patients with leukotoriene antagonists other than pranlukast.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Terumasa Miyamoto
Organization Professor Emeritus, University of Tokyo
Division name Department of internal medicine
Zip code
Address 7-3-1 ,Hongo, Bunkyo-ku, Tokyo,113-8655,JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Arioka
Organization International Medical Center of Japan
Division name Department of Respiratory Disease
Zip code
Address 1-21-1,Toyama,Shinjuku-ku ,Tokyo,162-8655,Japan
TEL 03-3202-7181
Homepage URL
Email harioka@imcj.hosp.go.jp

Sponsor
Institute Asthma QOL Research Study Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2007 Year 06 Month 01 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
2004 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2004 Year 10 Month 01 Day
Last follow-up date
2005 Year 03 Month 01 Day
Date of closure to data entry
2005 Year 06 Month 01 Day
Date trial data considered complete
2005 Year 09 Month 01 Day
Date analysis concluded
2006 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 05 Month 25 Day
Last modified on
2007 Year 05 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000866

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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