Status:
COMPLETED
12-week Open-label Evaluation of Efficacy and Safety of Indacaterol
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
In this 12-week study, patients were randomized to either open-label indacaterol or standard of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were assessed.
Eligibility Criteria
Inclusion
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
- Post-bronchodilator forced expiratory volume in 1 second (FEV1) \<80% and ≥30% of the predicted normal value
- Post-bronchodilator FEV1/FVC (Forced Vital Capacity) \<70%
- Current COPD bronchodilator treatment that includes a LABA bronchodilator or a fixed dose combination of LABA and Inhaled Corticosteroid (ICS)
Exclusion
- Patients with a history of asthma
- Patients who are currently being treated for COPD with tiotropium (Spiriva®)
- Patients with diabetes Type I or uncontrolled diabetes Type II
- Patients with a history of certain cardiovascular comorbid conditions
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01232894
Start Date
March 1 2011
End Date
May 1 2012
Last Update
November 19 2013
Active Locations (8)
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1
Novartis Investigative Site
Afula, Israel
2
Novartis Investigative Site
Ashkelon, Israel
3
Novartis Investigative Site
Holon, Israel
4
Novartis Investigative Site
Jerusalem, Israel