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 - NA

OVARTIS PHARMA SERVICES AG0 个研究点目标入组 752 人开始时间: 2018年2月23日最近更新: 2018年3月12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: 1
•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.

发起方