Comparison of Indacaterol and Tiotropium on Lung Function and Related Outcomes in Patients With Chronic Obstructive Pulmonary Disease (COPD) (INVIGORATE)
- Conditions
- Health Condition 1: null- Chronic Obstructive Pulmonary Disease
- Registration Number
- CTRI/2009/091/000277
- Lead Sponsor
- ovartis HealthCare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3500
Male and female adults aged greater than or equal to 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including:
1. Smoking history of at least 10 pack years, both current and ex-smokers are eligible
2. A documented history of at least 1 moderate or severe exacerbation in the previous 12 months
Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
Patients who have had a respiratory tract infection within 6 weeks prior to screening
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of indacaterol 150 µg once daily (o.d.) versus tiotropium 18 µg o.d. with respect to trough forced expiratory volume in 1 second (FEV1)Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Comparison of indacaterol 150 µg o.d. vs tiotropium 18 µg o.d. with regard to the rate of COPD exacerbationsTimepoint: 52 weeks