Exacerbation Study

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Tiotropium Bromide

Criteria

Inclusion Criteria:

• Male and female adults aged ≥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

Exclusion Criteria:

• 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

Other protocol-defined inclusion/exclusion criteria may apply