CTRI/2010/091/000631CompletedPhase 3
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 RheinGermany15 sites in 1 country16,800 target enrollmentStarted: June 24, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 16,800
- Locations
- 15
- Primary Endpoint
- 1. Time to death (all-cause mortality)
Study Overview
Brief Summary
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® in patients with Chronic Obstructive Pulmonary Disease (COPD). The primary outcome measures will be Time to death (all-cause mortality) and Time to first COPD exacerbation. The secondary outcomes will be Time to first major adverse cardiovascular event, Number of COPD exacerbations, Time to first hospitalisation due to COPD exacerbation and Number of hospitalisations due to COPD exacerbations. Target Sample size for India-500 subjects
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
- •Male or female patients 40 years of age or older.
- •Patients must be current or ex-smokers with a smoking history of 10 pack-years.
- •(Patients who have never smoked cigarettes must be excluded)
- •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
- •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.
Outcomes
Primary Outcomes
1. Time to death (all-cause mortality)
Time Frame: 24 Months
Secondary Outcomes
- 2. Number of COPD exacerbations(24 Months)
- 3. Time to first hospitalization due to COPD exacerbation(24 Months)
- 4. Number of hospitalizations due to COPD exacerbation(24 Months)
- 1. Time to first major adverse cardiovascular event(24 Months)
Investigators
Study Sites (15)
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