A randomized, double-blind, parallel group, 26-week study evaluating the efficacy, safety and tolerability of NVA237 given once or twice daily, in patients with moderate and severe chronic obstructive pulmonary disease

ovartis Pharma Services AG0 个研究点目标入组 752 人开始时间: 2015年5月18日最近更新: 2017年2月20日

研究概览

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•Written informed consent must be obtained before any assessment is performed.
•Male and female adults aged =40 years
•Patients with stable COPD according to the current GOLD strategy (GOLD 2014).
•Current or ex-smokers who have a smoking history of at least 10 pack years. An ex-smoker may be defined as a subject who has not smoked for = 6 months at screening.
•mMRC grade of at least 2 at Visit 101.
•Patients with airflow limitation indicated by a post-bronchodilator FEV1 = 30 % and <80 % of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at Visit 101.
•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 376
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 376

•Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
•Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
•Patients with Type I or uncontrolled Type II diabetes.
•Patients with a history of long QT syndrome or whose QTc measured at run-in (Fridericia method) is prolonged (>450 ms for males and >460 for females) and confirmed by a central assessor.
•Patients requiring long term oxygen therapy prescribed for >12 h per day.
•Patients with any history of asthma.

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