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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002367
Receipt No. R000002285
Scientific Title Efficacy of the additional effect of LTRA to the asthmatics who has taken both ICS and LABA.
Date of disclosure of the study information 2009/08/21
Last modified on 2011/08/26

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Basic information
Public title Efficacy of the additional effect of LTRA to the asthmatics who has taken both ICS and LABA.
Acronym Efficacy of the additional effect of LTRA to the asthmatics who has taken both ICS and LABA.
Scientific Title Efficacy of the additional effect of LTRA to the asthmatics who has taken both ICS and LABA.
Scientific Title:Acronym Efficacy of the additional effect of LTRA to the asthmatics who has taken both ICS and LABA.
Region
Japan

Condition
Condition bronchial asthma
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy of the additional effect of LTRA to the asthmatics who has taken both ICS and LABA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of change of ACT number (for four weeks)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 inhalation corticosteroid + long-acting beta-2 agonist as treatment continues for eight weeks.
Interventions/Control_2 10mg of montelukast sodium added for inhalation corticosteroid + long-acting beta-2 agonist as treatment and it continues for eight weeks.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patient to whom ICS 200-400 microgram (FP conversion) is administered.
2)Patient to whom LABA is administered.
3)The patient according to ACT who is not Total control though it is Well control.
4)Patient who was able to acquire agreement by document.
Key exclusion criteria 1)Patient who has previous history of side effect or hypersensitivity serious compared with element of research medicine
2)Patient judged to be improper according to doctor when targeting it
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Tohda
Organization Graduate School of Medicine Kinki University
Division name Department of Respiratory Medicine and Allegology
Zip code
Address 377-02 Ohnohigashi, Osaka-sayama, Osaka 589-0014,Japan.
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine Kinki University
Division name Department of Respiratory Medicine and Allegology
Zip code
Address 377-02 Ohnohigashi, Osaka-sayama, Osaka 589-0014,Japan.
TEL 072-366-0221
Homepage URL
Email iwanaga@med.kindai.ac.jp

Sponsor
Institute Kansai Asthma Research Network:KARN
Institute
Department

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 08 Month 21 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 Terminated
Date of protocol fixation
2008 Year 07 Month 29 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2009 Year 12 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 08 Month 21 Day
Last modified on
2011 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002285

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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