ISRCTN29148209进行中（未招募）2 期
An investigation into the effect of inhaled combined BUD/GLY/FORM on platelets in COPD as a potential cardioprotective mechanism: an exploratory, single-centre, investigator-blind, randomised controlled cross-over trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females aged =40 years old
- •2. Primary respiratory diagnosis of COPD
- •3. FEV-1 <80% predicted and FEV-1/FVC <0.7 at screening
- •4. Current or former smoker with at least 10 pack year smoking history
- •5. Able to demonstrate adequate inhaler technique with a pMDI inhaler and willing to take study medications as instructed
- •6. =2 moderate and/or =1 severe exacerbation of COPD (AECOPD) within the 12 months prior to recruitment*
- •7. Willing to undertake study procedures and assessments
- •8. Provided written informed consent
- •* A moderate exacerbation is classified as an AECOPD treated with oral antibiotics and/or corticosteroids without ED attendance and/or hospitalisation. A severe AECOPD is one that requires ED attendance and/or hospitalisation
排除标准
- •1. Other significant respiratory condition felt to be the primary cause for the patients symptoms and/or exacerbations (e.g. predominant asthma, bronchiectasis or interstitial lung disease)
- •2. Exacerbation of COPD requiring oral steroids and/or antibiotics within the 4 weeks prior to recruitment
- •3. Unstable vascular disease (e.g. unstable angina, acute myocardial infarction), cerebrovascular event (transient ischaemic attack or stroke), peripheral vascular disease (symptomatic intermittent claudication, critical limb ischaemia) within 3 months of screening.
- •4. Venous thromboembolic event (e.g. deep vein thrombosis or pulmonary embolism) within 3 months of screening
- •5. Treatment with 1 or more medication that will impact outcome measure assessment (e.g. clopidogrel, ticagrelor etc). *low dose Aspirin therapy will be permissible if taken at a stable dose throughout the study
- •6. Taking an inhaled corticosteroid (ICS) prior to study entry with a blood eosinophil count =0.3 x 10^9 per litre during the screening visit
- •7. (This criterium has been included to avoid risk to patients from ICS withdrawal during run-in and wash-out periods for patients considered to have required ICS by a clinician prior to study entry and with evidence of steroid responsive disease [Eos =0.3 x 10^9/L])
- •8. Known allergy/sensitivity to study medications
- •9. Current participation in another interventional clinical study within 30-days or, if involving an Investigational Product, 5-half-lives, whichever is longer
- •10. For women of child bearing potential only - currently pregnant, breast feeding, or planned pregnancy during the study or not using acceptable contraception, as judged by the investigator
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