A randomized, active controlled, double blind, double dummy, parallel group, design, multi-centre, trial to compare, the efficacy and safety of 2.5 microgm and 5 microgm Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 microgm delivered by the HandiHaler®

Boehringer Ingelheim Pharma GmbH Co KGBinger Strasse Ingelheim am RheinGermany0 个研究点目标入组 16,800 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
•2. Male or female patients 40 years of age or older.
•3. Patients must be current or ex-smokers with a smoking history of 10 pack-years. (Patients who have never smoked cigarettes must be excluded)
•4. All patients must have a diagnosis of COPD (P06-12085), and must meet the following criteria: Relatively stable airway obstruction with a post-bronchodilator FEV1 less than 70% of predicted normal and post-bronchodilator FEV1 / FVC less than 70%

•1.Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence the patients ability to participate in the study.
•2.Patients with a recent history (i.e., six months or less) of myocardial infarction.
•3.Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
•4.Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year.
•5.Known active tuberculosis.
•6.Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.

发起方

Boehringer Ingelheim Pharma GmbH Co KGBinger Strasse Ingelheim am RheinGermany