A randomised, double-blind, placebo-controlled, parallel group study to determine the effect of 12 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg, 5/5 µg) delivered by the Respimat® Inhaler, on exercise endurance time during constant work rate cycle ergometry in patients with Chronic Obstructive Pulmonary Disease (COPD) (TorractoTM) - TorractoTM

Boehringer Ingelheim Limited0 sites544 target enrollmentMarch 28, 2012

Overview

No summary available.

Registry

who.int

Start Date

March 28, 2012

End Date

September 26, 2013

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 chronic obstructive pulmonary disease and must meet the following spirometric criteria:
•Patients must have relatively stable airway obstruction with, at visit 1:
•\- a post\-bronchodilator 30% \= FEV1 \<80% of predicted normal (ECSC) and
•\- a post\-bronchodilator FEV1/FVC \<70% at Visit 1
•3\. Male or female patients, between 40 and 75 years (inclusive) of age on day of signing informed consent.
•4\. Patients must be current or ex\-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
•5\. Patients must be able to perform technically acceptable pulmonary function tests (spirometry), must be able to complete multiple symptom\-limited cycle ergometry tests (and for a subset also shuttle walk tests), as required in the protocol.
•6\. Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).
•Are the trial subjects under 18? no

•1\. Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of
•participation in the study, (ii) influence the results of the study, or (iii) cause concern
•regarding the patient’s ability to participate in the study
•2\. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or
•3\. Patients with a history of asthma.
•Patients with any of the following conditions:
•4\. A diagnosis of thyrotoxicosis
•5\. A diagnosis of paroxysmal tachycardia (\>100 beats per minute)
•6\. A history of myocardial infarction within 1 year of screening visit
•7\. Unstable or life\-threatening cardiac arrhythmia