Health Condition 1: null- Pulmonary Disease, Chronic Obstructive
Conditions
Interventions
Intervention1: Tiotropium Inhalation solution 2.5 microgm: Substance (INN): Tiotropium
Pharmaceutical form: Inhalation solution
Unit strength: 2.5 microgm (1.25 microgm per puff)
Route of administr
device
Dosage regimen: 1 inhalation once daily (a.m. dosing)
Control Intervention3: Tiotropium placebo Inhalation solution: Substance (INN): Tiotropium placebo
Pharmaceutical form: Inhalation soluti
inhaler
Dosage regimen: 2 inhalations once daily (a.m. dosing)
Sponsors
Boehringer Ingelheim Pharma GmbH Co KGBinger Strasse Ingelheim am RheinGermany
Eligibility
Inclusion criteria
Inclusion criteria: 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%
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to death (all-cause mortality)Timepoint: 24 Months;1. Time to death (all-cause mortality)Timepoint: 24 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first major adverse cardiovascular eventTimepoint: 24 Months;2. Number of COPD exacerbationsTimepoint: 24 Months;3. Time to first hospitalization due to COPD exacerbationTimepoint: 24 Months;4. Number of hospitalizations due to COPD exacerbationTimepoint: 24 Months | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Denmark, Ecuador, Finland, France, Georgia, Germany, Greece, Guatemala, Hungary, India, Ireland, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United States of America
Contacts
Public ContactDr Shubhangi Desai
SIRO Clinpharm Pvt. Ltd.
Outcome results
None listed