EUCTR2012-003995-38-BE进行中（未招募）1 期
A double-blind, placebo-controlled, study examining the effect of orally administered QAW039 (450 mg QD) on FEV1 and ACQ in non-atopic, asthmatic patients with a baseline, pre-bronchodilator FEV1 of 40-80% predicted, inadequately controlled with low dose ICS therapy
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 530
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent must be obtained before any assessment is performed
- •2. Males and females of any race who are aged =18 years
- •3. Patients with a diagnosis of persistent asthma (according to GINA2011) for a period of at least 6 months prior to screening
- •4. Patients with a pre-bronchodilator FEV1 value of 40% to 80% of individual predicted value at screening and prior to treatment. The FEV1 results should meet the ATS/ERS criteria for acceptability and repeatability (in case of screening failure due to ATS/ERS criteria, rescreening is allowed once)
- •5. Patients must be either non-atopic as defined by:
- •a. A history of perennial symptoms with no clear inhaled allergic trigger AND
- •b. A negative skin prick test (< 3mm diameter above background) either historically or at Screening AND
- •c. A negative specific IgE (e.g. RAST/CAP) test (<0.35 IU eq./ml)either historically or against a defined panel of common aeroallergens
- •atopic/allergic as diagnosed historically or at Screening by either a skin prick test (= 3mm diameter above background) or a positive specific IgE (e.g. RAST/CAP) test (=0.35 IU eq./ml)
- •6. Patients who are demonstrated to have reversible airway obstruction or airways hyper-reactivity or have shown either of such responses in previous test(s) within the last year
- •Reversible airway obstruction demonstrated at Screening is defined as either:
- •a. an increase of =12% and =200 ml in FEV1 over the patient’s pre-bronchodilator value in liters or
- •b. an increase of =10% in % of predicted FEV1 over the patient’s pre-bronchodilator % of predicted FEV1 within 10-15 minutes after inhaling a total of 360 µg of albuterol or 400 µg salbutamol via MDI (reversibility test). The administration of albuterol or salbutamol for the reversibility test is to be within 30 minutes after pre-bronchodilator spirometry.
- •A positive airways hyper-reactivity (AHR) test result is defined as a provoked fall in FEV1 of 20% (PC20) by methacholine at =8 mg/ml when not on ICS or =16 mg/ml on ICS therapy. The use of either histamine < 10mg/ml or acetylcholine < 20mg/ml in place of methacholine is also acceptable.
- •7. An ACQ7 score = 1.5 prior to treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 420
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- •2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (CRTH2 antagonists)
- •3. History of long QT syndrome or whose current QTc measured at runin (Fridericia’s) is prolonged > 450 msec for males and females and confirmed by a central assessor
- •4. Pregnant or nursing (lactating) women
- •5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
- •6. Acute illness other than asthma at the start of the study
- •7. History of life-threatening asthma, including a history of significant hypercarbia (pCO2>45mmHg), prior intubation, respiratory arrest, or seizures as a result of asthma
- •8. Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening
- •9. Patients who have a clinically significant abnormality on a 12 lead ECG recorded within one month prior to screening. Patients who have a clinically significant abnormality on a 12-lead ECG recorded at run-in
- •10. Patients with serious co-morbidities including, but not limited to, uncontrolled diabetes (HbA1c =8%), heart failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune diseases
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