A 52-week Treatment, Randomized, Double-blind, Placebo-controlled, With Open-label Tiotropium, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Patients With Chronic Obstructive Pulmonary Disease

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 17 人开始时间: 2009年10月30日最近更新: 2023年9月4日

试验速览

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•Male or female adults> 40 years of age, who have signed an Informed Consent Form before the start of any procedure related to the study.
•Patients with moderate to severe stable COPD (Stage II or Stage III) in accordance with the GOLD 2008 Guidelines.
•Current smokers or former smokers who have a smoking history of at least 10 packages per year. (Ten packages per year are defined as 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years, etc.)
•Patients with a post-bronchodilator FEV1> 30% and <80% of the normal predictive, and a post-bronchodilator FEVVFVC <0.7 at Visit 2 (day * 14)
•Patients with, according to electronic journal data between Visit 2 (-14) and Visit 3 (day 1), a total score of 1 or more in at least 4 of the 7 days prior to Visit 3 (For information on score see Section 7.4,3,1.)

•Pregnant or breastfeeding women (pregnancy confirmed with a positive urine pregnancy test).
•Women with reproductive potential, unless they use an approved method of medical or surgical contraception.
•Patients who require long-term oxygen therapy (> 15 h per day) daily for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airway disease in the 6 weeks prior to Visit 1 or between Visit 1 ( day -21) and Visit 3 (day 1).
•Patients who have had an infection of the lower respiratory tract within 6 weeks prior to Visit 1 (day -21). Patients who develop a lower respiratory tract infection or an exacerbation of COPD during the selection period (until Visit 3 (day 1)) will not be eligible, but will be allowed to be re-selected later (at least 6 weeks). after resolution of the lower respiratory tract infection)
•Patients who, in the opinion of the researcher or staff responsible for Novartis, have a clinically relevant laboratory abnormality or a clinically significant condition
•Patients with a history of asthma, suggested by (among others, but not in a restrictive way) a blood eosinophil count> 600 / mm3 (at visit 1) or a start of symptoms before the age of 40
•Patients with a history of prolonged QT syndrome or whose QTc measured on Visit 1 (day -21) (Fridericia Method) is prolonged (> 450 ms for men or> 470 for women).
•Treatments for COPD and associated conditions

发起方

OVARTIS BIOSCIENSES PERU S.A.,