UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of CTLA4-Ig on severe asthma (ECSA) study ; Double blind, placebo controlled, phase IIa trial of CTLA4-Ig (abatacept) on severe asthma
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Akio Mori, MD, PhD
Organization	National Hospital Organization, Sagamihara National Hospital
Division name	Clinical Research Center
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	Akio Mori, MD, PhD
Organization	National Hospital Organization, Sagamihara National Hospital
Division name	Clinical Research Center
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000018891