EUCTR2018-004381-33-BE进行中（未招募）1 期
Randomized, subject and investigator blinded, placebo-controlled study to demonstrate the anti-inflammatory effect of fevipiprant (QAW039) in moderate-severe asthma patients with high sputum and blood eosinophils
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 58
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
入选标准
- •All Subjects (Asthma patients, Healthy volunteers):
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Male and female subjects aged = 18 years at screening
- •3. Able to communicate well with the investigator, to understand and comply with the requirements of the study.
- •Moderate-to-severe asthma patients (Asthma patients):
- •1. Patients with a diagnosis of asthma currently treated with at least medium dose of ICS, alone or with any other asthma controller therapy, except those listed as prohibited medications. Patients must be on stable doses of asthma medications for at least 4 weeks prior to screening.
- •2. A clinical diagnosis of asthma supported by at least one of the following within five years prior to screening :
- •- Reversible airway obstruction defined as an increase of = 12% and = 200 ml in FEV1 or FVC over the patient’s pre-bronchodilator value within 30 minutes after inhaling a
- •total of 360 µg of albuterol or 400 µg salbutamol via metered dose inhaler
- •(reversibility test).
- •- A positive airway hyper-reactivity (AHR) test result 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.
- •- A change in FEV1 of = 12% over two measurements within 12 months.
- •3. ACQ7 score = 1.25 at screening and baseline visits, which may be repeated once at each visit.
- •4. Demonstrate ability to produce a good quality induced-sputum sample at baseline visits.
- •Note: Sputum induction test may be repeated once at each applicable visit.
- •5. Sputum eosinophil count = 2% and blood eosinophil count = 250 cells/µL at applicable screening (visit 1) and baseline visits (visit 20 and visit 30).
- •Note: Re-testing is allowed once to qualify patient at that visit.
- •Healthy volunteers (Healthy volunteers):
- •1. Subject must be in good health as determined by past medical history, current medications, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- •Note: Subjects with well-controlled, mild, non-respiratory diseases can participate as long as they are considered healthy and stable in the investigator's judgement.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •All Subjects (Asthma patients, Healthy volunteers):
- •1. Use of other investigational drugs at the time of screening, or within 5 half-lives of experimental drug at the time of screening, or within 30 days of last dose of experimental drug at the time of screening, whichever is longer; or longer if required by local regulations.
- •2. Cirrhosis, hepatic failure, chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV). At screening, a positive HBV surface antigen (HBsAg) test, or if standard local practice, a positive HBV core antigen test, excludes a subject. Subjects with a positive HCV antibody test should have HCV RNA levels measured. Subjects with positive (detectable) HCV RNA should be excluded.
- •3. At screening, a positive HIV test or is taking anti-retroviral medications, as determined by medical history and/or subject’s verbal report.
- •4. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases.
- •5. Donation or loss of 450 mL or more of blood within eight weeks prior to screening visit or longer if required by local regulation.
- •6. Plasma donation (>150 mL) within 30 days prior to screening visit.
- •7. History of drug or alcohol abuse within the 12 months prior to screening visit.
- •8. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless using basic methods of contraception
- •9. At screening, pregnant or nursing (lactating) women.
- •10. History of parasitic infestation within 6 months prior to screening
- •Moderate-to-severe asthma patients (Asthma patients):
- •1. Patients with a current or past medical history of conditions other than asthma or allergic rhinitis that could result in elevated blood or sputum eosinophils (e.g., hypereosinophilic syndrome, chronic eosinophilic pneumonia, Churg-Strauss Syndrome).
- •2. History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes
- •3. Patients with history of concomitant chronic or severe pulmonary disease other than asthma (e.g., COPD, bronchiectasis, sarcoidosis, interstitial lung disease, cystic fibrosis, active tuberculosis).
- •4. Patients on statin therapy with a CK level >2 X ULN at screening.
- •5. Patients on prohibited treatment listed in Table 6-2.
- •6. Patients who have had an asthma exacerbation requiring systemic corticosteroids, hospitalization, or emergency room visit within 4 weeks prior to and/or during screening or baseline.
- •7. Patients who have had a respiratory tract infection or asthma worsening within 4 weeks of screening.
- •8. Subjects who have smoked or inhaled any foreign substance (marijuana, etc.) other than asthma medications within the 4 week period prior to screening, or who have a cigarette
- •smoking history of greater than 10 pack years (Note: 10 pack years = 1 pack/day during 10 yrs., or ½ pack/day during 20 yrs.) or positive test for continine at the time of screening.
- •9. Patients with a history of myocardial infarct
研究者
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