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

Pearl Therapeutics Inc.,0 个研究点目标入组 137 人开始时间: 2017年5月11日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•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 [Or reference norms applicable to other regions, e.g., for Japan, use JRS reference equations; (JRS, 2013)] as below:
•At Visit 1, FEV1/FVC ratio must be < 0.70 and FEV1 must be ≥ 50 to < 80% predicted normal value
•At Visit 2, post-bronchodilator FEV1/FVC ratio of < 0.70 and post-bronchodilator FEV1 must be ≥ 50% to < 80% predicted normal value
•At Visit 3, the average of the -60 min and -30 min pre-dose FEV1 assessments must be ≥ 50 to < 80% predicted normal value
•(please for more reference review page 25 of the protocol)

•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
•e.Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months [i.e., lobectomy, bronchoscopic lung volume reduction (endobronchial blockers, airway bypass, endobronchial valves, thermal vapor ablation, biological sealants, and airway implants)]
•(please for more reference review page 26 of the protocol)

发起方