A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, MULTI-CENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF PT009 COMPARED TO PT005 ON COPD EXACERBATIONS OVER A 52-WEEK TREATMENT PERIOD IN SUBJECTS WITH MODERATE TO VERY SEVERE COPD (SOPHOS)

Pearl Therapeutics Inc.,0 个研究点目标入组 0 人开始时间: 2017年1月19日最近更新: 2023年9月4日

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•Each subject must meet the following criteria, in relationship to Visit 1, unless otherwise noted, to be enrolled in this study:
•1.Give their signed written informed consent to participate
•2.Are at least 40 years of age and no older than 80 years
•3.COPD Diagnosis: subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) [Celli, 2004] or by locally applicable guidelines, e.g., JRS Guidelines [JRS, 2013] characterized by progressive airflow limitation associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking
•4. COPD Severity: subjects with established COPD clinical history and who are symptomatic (CAT ≥ 10) and severity defined and calculated using NHANES III reference equations

•Subjects who meet any of the following criteria, in relationship to Visit 1, will be excluded from the study unless otherwise stated.
•1.Respiratory
•a.Current diagnosis of asthma, in the opinion of the Investigator
•b.COPD due to α1-Antitrypsin Deficiency
•c.Sleep apnea that, in the opinion of the Investigator, is uncontrolled
•d.Other Respiratory Disorders: known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary thromboembolic disease
•Note: allergic rhinitis is not exclusionary)

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