Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease (INTRUST-2)
- Registration Number
- CTRI/2009/091/000564
- Lead Sponsor
- ovartis Health Care Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1126
* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
1.Smoking history of at least 10 pack-years
2.Post-bronchodilator FEV1 <=65% and >=30% of the predicted normal value
3. Post-bronchodilator FEV1/FVC (forced vital capacity) <70%
* Patients who have received systemic corticosteroids and/or antibiotics and/or was hospitalized 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 Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Standardized area under the curve (AUC) for forced expiratory volume in 1 second (FEV1) between 5 min - 8 h post-doseTimepoint: Time Frame: 12 weeks
- Secondary Outcome Measures
Name Time Method Trough FEV1 24h post-doseTimepoint: Time Frame: 12 weeks;FEV1 AUC 5 min - 4 hTimepoint: Time Frame: 12 weeks;FEV1 AUC 5 min - 4 hTimepoint: Time Frame: Day 1;FEV1 AUC 5 min - 8 hTimepoint: Time Frame: Day 1;Trough FEV1Timepoint: Time Frame: After 1 day