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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016283
Receipt No. 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

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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
Email 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
Email moriakiojp@yahoo.co.jp

Sponsor
Institute National Hospital Organization, Sagamihara National Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018891

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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