Assessing the relationship between cardiovascular and small airway disease and acute events in COPD: the ARCADIA study protocol

niversity of Rome Tor Vergata0 个研究点目标入组 500 人开始时间: 2023年3月15日最近更新: 2023年7月18日

适应症

试验速览

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37414133/ (added 07/07/2023)

•1. Clinical and functional diagnosis of COPD
•2. Forced expiratory volume in the 1st second (FEV1)/forced vital capacity (FVC) ratio <0.7 and/or FEV1/FVC (or FEV1/vital capacity [VC]) < lower limit of normal (LLN)
•3. Clinical stability =3 months (no mild moderate or severe exacerbations)
•4. Both genders
•5. Age =40 years
•6. Smoking history =10 p/y

•1. Previous or current history of bronchial asthma
•2. Restrictive lung disease or interstitial lung disease
•3. Active or under treatment neoplasms
•4. Shift of inhalation therapy in the 3 months prior to study entry
•5. Inability to perform reliable and repeatable pulmonary function tests
•6. Oxygen therapy >18 hours a day
•7. Diagnosed with clinically significant bronchiectasis (overt diagnosis of bronchiectasis on chest computed tomography [CT] which is the patient's primary diagnosis)
•8. Severe obstructive sleep apnea syndrome (apnea/hypopnea index >30/h)
•9. Pregnancy

发起方

niversity of Rome Tor Vergata