EUCTR2016-004140-10-BG进行中（未招募）1 期
A randomised, double-blind, placebo- and active-controlled, parallel-arm, multicentre study to assess efficacy, pharmacokinetics, safety and tolerability of multiple dose levels of abediterol administered once daily for four weeks, in patients with asthma symptomatic on inhaled corticosteroids
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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. Patient or patient’s parents/legal guardians who provided written informed consent (assent for underage patients) prior to any study-specific procedures.
- •2. Men and non-pregnant, non-lactating women between 12 and 95 years of age, inclusive.
- •3. Non-smoker or former smoker who quit =6 months prior to Visit 1 and have a total smoking history of =10 pack-years.
- •4. Patient with documented clinical diagnosis of asthma for =6 months before Visit 1 according to GINA guidelines.
- •5. Patient with normal or controlled blood pressure (defined as systolic blood pressure [SBP] between 90 and 150 mm Hg, and diastolic blood pressure [DBP] between 40 and 90 mm Hg) at Screening, measured after resting in the supine position for 5 min. Patients stable on anti-hypertensive can be included.
- •6. Patient with no relevant clinical laboratory findings at Screening (Visits 1 or 2) as judged by the Investigator.
- •7. Patient on stable dose of ICSs or ICS/LABA FDC, for at least 1 month prior to Visit 1, at the doses approved in the country of enrolment.
- •8. Patient with a compliance with their ICS with inhalation treatment during Run-in Period of at least 75%, as measured with the eDiary.
- •9. Patient with pre-bronchodilator FEV1at Visit 2 =40% and =90% of predicted (mean of 2 pre-bronchodilator measurements taken 30 min apart).
- •10. Patient who fulfils reversibility criteria to salbutamol/albuterol at Visit 2, with reversibility as defined per the 2005 American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria, ie, =12% and =200 mL after administration of 4 puffs of salbutamol/albuterol.
- •11. Patient with an asthma symptom score >0 as recorded on eDiary on at least 3 out of the last 7 days of Run-in Period.
- •12. Patient who demonstrates the ability to use the study inhalation device properly.
- •13. Patient able to perform acceptable pulmonary function testing for FEV1according to ATS/ERS acceptability criteria.
- •14. Negative pregnancy test (serum pregnancy test at Screening) for female patients.
- •15. Female patients must be 1 year post-menopausal, surgically sterile, or must be able to adhere to the conditions of contraceptive requirements as described in the protocol. Male patients must be surgically sterile or must be able to adhere to the conditions of contraceptive requirements as described in the protocol.
- •16. Patients willing not to donate blood during the study and for 3 months following their last dose of IP for patients participating in the PK sub-study and for 8 weeks for other patients.
- •17. Patient willing and able to follow study directions and restrictions.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 455
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 85
排除标准
- •1. Patient has known or suspected hypersensitivity to the IP or excipients, including lactose (Note: lactose intolerance is not an exclusion criterion).
- •2. Patient who has used systemic steroid in the 6 weeks before Visit 1.
- •3. Patient with a history of hospitalisation due to asthma in the 6 months prior to Visit 1 or a history of intubation because of asthma at any time in their lifetime.
- •4. Patient with any active pulmonary disease other than asthma.
- •5. Patient non-compliant with study procedures in the Run-in Period – as judged by the Investigator.
- •6. Patient under treatment with biologicals such as monoclonal antibodies or chimeric biomolecules including omalizumab, mepolizumab, and reslizumab within 6 months or 5 half-lives before Visit 1, whichever is longer.
- •7. Patient treated with any investigational drug within 30 days (or 5 half-lives, whichever is longer) prior to Visit 1.
- •8. Patient on treatment with strong cytochrome P450 (CYP)3A4 inhibitors such as ketoconazole or itraconazole or CYP3A4 inducers such as rifampin at Visit 1 or within 14 days prior to administration of IP.
- •9. Patient with a history, laboratory abnormality, or clinical suspicion of any clinically relevant disease or disorder, including uncontrolled hypertension or uncontrolled diabetes, which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient’s ability to participate in the study, or any other safety concerns in the opinion of the Investigator.
- •10. Patient with diagnosis of any kind of chronic hepatitis or know human immunodeficiency virus (HIV) infections at the time of enrolment.
- •11. Patient with any active malignancy or treatment thereof within the five years prior to enrolment.
- •12. Patient with any clinically important abnormalities in rhythm, conduction, or morphology of the screening 12-lead ECG as judged by the Investigator on the screening ECG.
- •13. Patient with prolonged QT interval using Fridericia’s correction =450 msec on the screening ECG or family history of long QT syndrome.
- •14. Patient with PR (PQ) interval prolongation (>240 msec), intermittent second or third degree atrio-ventricular (AV) block or AV dissociation on the screening ECG.
- •15. Patient with heart rate (HR) <45 beat per minute (bpm) or >90 bpm at Screening ECG.
- •16. Patient with implanted cardiac defibrillator and patients with sustained symptomatic ventricular and/or atrial tachyarrhythmia.
- •17. Patient with any contraindication against the use of sympathomimetic drugs as judged by the Investigator.
- •18. Patient with unstable angina pectoris or stable angina pectoris classified higher than Canadian Cardiovascular Society Class II, or a myocardial infarction, or stroke within 6 months before Visit 1.
- •19. Patient with a history of hospitalisation within 12 months caused by heart failure or a diagnosis of heart failure higher than New York Heart Association (NYHA) Class II.
- •20. Patient with previous participation or prior screen failure in the current study.
- •21. Patient with a history of or current alcohol or drug abuse (including marijuana), as judged by the Investigator.
- •22. Patient with planned in-patient surgery, major dental procedure or hospitalisation during the study.
- •23. Patient involved in the planning and/or conduct of the study (applies to both AstraZeneca staff, contract research organisation (CRO) staff and/or staff at the study site).
- •24. Vulnerable p
研究者
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