A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 Î¼g / 5 Î¼g; 5 Î¼g / 5 Î¼g) (delivered by the RESPIMAT) compared with the individual components (2.5 Î¼g and 5 Î¼g tiotropium, 5 Î¼g olodaterol) (delivered by the RESPIMAT) in patients with Chronic Obstructive Pulmonary Disease (COPD) [TOnadoTM 2]

Boehringer Ingelheim India Pvt Ltd0 个研究点目标入组 2,500 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior
•to participation in the trial, which includes medication washout and restrictions.
•2. All patients must have a diagnosis of COPD [P10-01267] and must meet the
•following spirometric criteria:
•Patients must have relatively stable airway obstruction with a post-bronchodilator
•FEV1 < 80% of predicted normal (ECSC, [R94-1408]; GOLD II - IV, [P10-01267] and
•a post-bronchodilator FEV1/FVC <70% at Visit 1 (See Appendix 10.3 for ECSC
•predicted normal equations).
•3. Male or female patients, 40 years of age or older.
•4. Patients must be current or ex-smokers with a smoking history of more than 10 pack
•years. (see Appendix 10.3 for calculation):
•Patients who have never smoked cigarettes must be excluded.
•5. Patients must be able to
•perform technically acceptable pulmonary function tests ,
•perform technically acceptable PEF measurements,
•maintain records (Patient Daily e-Diary) during the study period ,
•perform all other assessments (e.g. complete self administed questionnaires),
•as required in the protocol.
•6. Patients must be able to inhale medication in a competent manner from the
•RESPIMAT inhaler

•Patients with a significant disease other than COPD
•Patients with a history of asthma.
•A diagnosis of thyrotoxicosis
•A diagnosis of paroxysmal tachycardia (100 beats per minute) (due to the known class side effect profile of Ã?2-agonists).
•A history of myocardial infarction within 1 year of screening visit (Visit 1).
•Unstable or life-threatening cardiac arrhythmia.
•Hospitalization for heart failure within the past year.
•Patients who regularly use daytime oxygen therapy for more than one hour per day
•Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1).
•Pregnant or nursing women.
•Women of childbearing potential not using a highly effective method of birth control.

发起方

Boehringer Ingelheim India Pvt Ltd