UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000724 |
|---|---|
| Receipt number | 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 17:20:32 |
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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
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
harioka@imcj.hosp.go.jp
Sponsor or person
Institute
Asthma QOL Research Study Group
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
