Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Salmeterol Xinafoate

Criteria

Inclusion Criteria:

1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) and:

• Smoking history of at least 20 pack-years

• Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value

• Post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

1. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period

2. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1

3. Patients with concomitant pulmonary disease

4. Patients with a history of asthma

5. Patients with diabetes Type I or uncontrolled diabetes Type II

6. Any patient with lung cancer or a history of lung cancer

7. Patients with a history of certain cardiovascular comorbid conditions

8. Patients who have been exposed to indacaterol previously. (Except for any patient who enrolled in Study CQAB149B1302)

Other protocol-defined inclusion/exclusion criteria may apply