EUCTR2013-004404-19-GB进行中（未招募）不适用
A Randomized, Double-blind, Placebo-controlled, Crossover Study toAssess the Effect of 28 Day Treatment with Fostair® pMDI 200/12 on biomarkers of platelet adhesion in Patients with Idiopathic pulmonary fibrosis. - Effect of Fostair® pMDI on biomarkers of platelet adhesion in IPF
Hull and East Yorkshire Hospitals NHS Trust0 个研究点开始时间: 2014年3月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Male or female subjects from 40 to 85 years of age
- •2. Diagnosis of definite IPF according to ATS/ERS Consensus Statement (2011) using either HRCT or surgical lung biopsy (SLB).
- •2.TLco of = 30 % predicted ( historical measure accepted as long as within the last year).
- •3. Able to maintain O2 saturation of = 89% while breathing room air at rest.
- •4. FVC of 50-80% predicted value
- •5. Negative serum pregnancy test at screening and negative urine pregnancy test at randomisation for female subjects of childbearing potential.
- •6. Competency to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form (ICF); subjects must sign the form prior to the initiation of any study procedures, unless the assessment is performed as standard of care for this disease.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Clinically significant respiratory diseases other than IPF, including asbestosis, other pneumoconiosis or hypersensitivity pneumonitis.
- •2. Clinically significant heart disease defined as a myocardial infarction documented by an ST elevation (STEMI) on electrocardiogram (ECG) within 6 months prior to screening, percutaneous coronary intervention or coronary artery bypass surgery within 6 months prior to screening, unstable angina pectoris, congestive heart failure (NYHA class III/IV or known left ventricular ejection fraction < 25%),ischaemic heart disease, right heart failure, significant right ventricular hypertrophy, or uncontrolled arrhythmia.
- •3. Current smokers
- •4. Use of any inhaled long acting beta-agonist or inhaled steroid within the 3 months prior to screening
- •5. Use of any medication to or possibly indicated in the treatment of IPF, such as pirfenidone, and oral corticosteroids.
- •6. Use of any Antiplatelet therapy which may alter assessment of study end points e.g. clopidogrel, Prasugrel, Dipyridamole etc.
- •7. History of cancer, precancerous state (eg, familial polyposis, BRCA1, BRCA2, carcinoma in-situ), other than non-melanomatous skin cancer, within 5 years prior to screening.
- •8. History or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion.
- •9. Participation in an investigational drug or device trial < 30 days prior to screening.
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