A Randomized, Double Blind, Chronic Dosing (24 Weeks), Placebo Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects with Moderate to Very Severe COPD, Compared with Placebo

Pearl Therapeutics, Inc.0 个研究点目标入组 1,614 人开始时间: 2015年9月1日最近更新: 2017年10月2日

适应症

试验速览

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•Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
•Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS).
•Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
•Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of <0.70.
•FEV1 must be <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms applicable to other regions).
•Please refer to the study protocol for the complete inclusion criteria list.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 888
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 726

•Significant diseases other than COPD, ie, disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
•Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.
•Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
•Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
•Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
•Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.
•Subjects who have a history of hypersensitivity to ß2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.
•Please refer to the study protocol for the complete exclusion criteria list.

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