UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002367 |
|---|---|
| Receipt number | 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 11:24:14 |
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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
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
iwanaga@med.kindai.ac.jp
Sponsor or person
Institute
Kansai Asthma Research Network:KARN
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002285
