Severe asthma
Conditions
Interventions
CTLA4-Ig is administered in 0, 2, 4, 8, 12, 16, and 20 wks.
Placebo is administered in 0, 2, 4, 8, 12, 16, and 20 wks.
Sponsors
National Hospital Organization, Sagamihara National Hospital
National Hospital Organization Minami-Okayama Medical Center, National Hospital Organization Tokyo National Hospital, Kyushu
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the mean FEV1 from baseline between two groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactAkio Mori, MD, PhD
National Hospital Organization, Sagamihara National Hospital Clinical Research Center
Outcome results
None listed