UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016283 |
|---|---|
| Receipt number | R000018891 |
| Scientific Title | Effect of CTLA4-Ig on severe asthma (ECSA) study ; Double blind, placebo controlled, phase IIa trial of CTLA4-Ig (abatacept) on severe asthma |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2016/07/22 11:50:14 |
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Basic information
Public title
Effect of CTLA4-Ig on severe asthma (ECSA) study ; Double blind, placebo controlled, phase IIa trial of CTLA4-Ig (abatacept) on severe asthma
Acronym
Effect of CTLA4-Ig on severe asthma (ECSA) study
Scientific Title
Effect of CTLA4-Ig on severe asthma (ECSA) study ; Double blind, placebo controlled, phase IIa trial of CTLA4-Ig (abatacept) on severe asthma
Scientific Title:Acronym
Effect of CTLA4-Ig on severe asthma (ECSA) study
Region
| Japan |
Condition
Condition
Severe asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine efficacy of CTLA4-Ig on adult severe asthma patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The difference in the mean FEV1 from baseline between two groups
Key secondary outcomes
The difference and the change in FEV1, V25, V50, FEF25-75%, PEF and FCV from baseline.
The number of clinically significant exacerbation of asthma.
The change in the cytokine production and the proliferation of peripheral blood T-cell.
The number of the use of rescue drug.
PEF Values in the early morning.
ACQ score.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CTLA4-Ig is administered in 0, 2, 4, 8, 12, 16, and 20 wks.
Interventions/Control_2
Placebo is administered in 0, 2, 4, 8, 12, 16, and 20 wks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Poor asthma control notwithstanding high-dose inhaled steroid, defined by Japanese asthma guideline 2012.
More than twice/year or once/6 months clinically significant asthma exacerbation.
Meet at least one of the following criteria,
-sputum eosinophilia more than 3%.
-FeNO more than 50ppb.
-peripheral blood eosinophils more than 3x108/L(last 12 months) or 1.5x108/L (observation period).
-asthma deteriorated after 25% decrease in inhaled steroid dose.
Prescribed high-dose inhaled steroid (more than 800 microgram BDP equivalent/day) plus more than one controller.
Can perform spirometry.
Can keep asthma diary.
Key exclusion criteria
Administration of abatacept in the past.
Rheumatoid arthritis.
Respiratory disorders other than asthma.
Current malignancy or past history of (within 5 years) malignancy.
Other clinically serious health problems.
Active infectious diseases or psoriasis.
Those who are pregnant, under-lactation, or desire pregnancy.
Administration of live vaccine within past 3 months or during the trial period or those who desire live vaccine within 3 months from the end of the trial.
Omalizumab use within past 3 months.
History or suspicion of alcohol or drug abuse within past 2 years.
Enrollment in other clinical trials within past 3 months.
Other conditions that doctors consider not eligible.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Mori, MD, PhD |
Organization
National Hospital Organization, Sagamihara National Hospital
Division name
Clinical Research Center
Zip code
Address
18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa, 252-0392 JAPAN
TEL
042-742-8311
moriakiojp@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Mori, MD, PhD |
Organization
National Hospital Organization, Sagamihara National Hospital
Division name
Clinical Research Center
Zip code
Address
18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa, 252-0392 JAPAN
TEL
042-742-8311
Homepage URL
moriakiojp@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization, Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Science Research Grants for Research on Rare and Intractable Diseases from Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization Minami-Okayama Medical Center, National Hospital Organization Tokyo National Hospital, Kyushu
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
九州大学病院（福岡県） Kyushu University Hospital
国立病院機構南岡山医療センター（岡山県）National Hospital Organization Minami-Okayama Medical Center
国立病院機構東京病院（東京）National Hospital Organization Tokyo National Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | 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
| 2014 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 20 | Day |
Last modified on
| 2016 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018891
