Tokyo Asthma Study; TOAST
- Conditions
- Severe asthma
- Registration Number
- JPRN-jRCTs031190237
- Lead Sponsor
- Fukunaga Koichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1) Asthma patients over 20 years old
2) Weight over 40kg
3) Compliance with inhaled steroid (ICS) is over 80% and fluticasone (FP) equivalent ICS has been taken over 1000 micro g/day since 3 months before.
4) In addition to take ICS since 3 months before, at least one long-term administration drug (long -acting beta2 inhalation stimulant (LABA), leukotriene receptor antagonist, inhaled anticholinergic or theophylline) taking.
5) Blood eosinophil count before treatment with benralizumab is over 150 / micro L
6) In addition to the above criteria, the patient must meet at least one of the following criteria.
(1) At least one asthma exacerbation has been diagnosed within two years.
The definition of exacerbation is as follows
(Deterioration requiring treatment with systemic steroids for at least 3 days (when be taken systemic steroids as a long-term medicine, it is defined as temporary increase from maintenance dose), or aggravation requiring emergency outpatient consultation or emergency hospitalization due to asthma)
(2) ACQ-5 score is under1.5 (control failure)
(3) Pre-bronchodilator FEV1 is <80% of predicted value
1) Patient who cannot obtain written consent by his/her own free will.
2) Patient complicated with bronchiectasis, diffuse pan bronchiolitis, collagen disease, pulmonary hypertension, sequelae of tuberculosis, interstitial pneumonia, allergic bronchopulmonary aspergilli / mycosis
3) Patient diagnosed with COPD
4) Patient who is smoking or have a history of smoking within 6 months
5) Malignant tumors: patient is in disease or within a year after remission
6) Patient was diagnosed with eosinophilia syndrome, eosinophilic polyangiitis granulomatous disease
7) Patient was diagnosed with parasitic helminth infection within 6 months
8) Patient have already received clinical trials or treatments of benralizumab
9) Patient received bronchial hyperthermia within a year
10) Have a history of anaphylaxis for biological products
11) Patient is being treated with other biologics and the last medication is less than a month
12) Pregnant or nursing woman
13) The condition is not stable because of cardiovascular or gastrointestinal tract, liver, kidney, nerve, musculoskeletal, infection, endocrine, metabolism, blood, mental disorder etc. and serious physical disorder. In addition, a principal investigator or sub-investigators judged that the following items may apply
(1)Affects the safety of the patient while the study period.
(2)Influence the study results and their interpretation
(3)The study will not able to be completed with the condition or situation of the patient
14) Patient diagnosed with acute upper or lower respiratory tract infection requiring administration of antibiotics or antivirals
15) Patient with a history of hypersensitivity for benralizumab and its components.
16) In addition, the attending physician judged the patient as inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from the baseline of ACQ-5 at 24 weeks after starting treatment.
- Secondary Outcome Measures
Name Time Method