A clinical trial to study the effects and safety of 2.5 microgram and 5 microgram Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 microgram delivered by the HandiHaler in patients with Chronic Obstructive Pulmonary Disease (COPD).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- CTRI/2010/091/000631
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH Co KGBinger Strasse Ingelheim am RheinGermany
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 16800
- 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) 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Time to death (all-cause mortality) 24 Months
- Secondary Outcome Measures
Name Time Method 1. Time to first major adverse cardiovascular event 24 Months 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
Trial Locations
- Locations (15)
Allergy Asthma Associates
🇮🇳Mysore, KARNATAKA, India
Asthma Allergy Centre
🇮🇳Mumbai, MAHARASHTRA, India
Asthma Bhawan
🇮🇳Jaipur, RAJASTHAN, India
Cancer Care Clinic
🇮🇳Nagpur, MAHARASHTRA, India
Chennai Thoracic Research Institute,
🇮🇳Chennai, TAMIL NADU, India
Dayanand Medical College & Hospital (D M C & Hospital)
🇮🇳Ludhiana, PUNJAB, India
Dr. Khippals Clinic
🇮🇳Jaipur, RAJASTHAN, India
Getwell Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Kamineni Hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
Karthik Polyclinic - Asthma Allergy Respiratary Care
🇮🇳Coimbatore, TAMIL NADU, India
Scroll for more (5 remaining)Allergy Asthma Associates🇮🇳Mysore, KARNATAKA, IndiaDrMahesh P APrincipal investigator918212331546mahesh1971in@yahoo.com