Overview

Efficacy and Safety of Indacaterol in Adults (40 Years and Above) With Chronic Obstructive Pulmonary Disease (COPD)

Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
0
Participant gender:
All
Summary
This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Criteria
Inclusion Criteria:

- Adults aged ≥ 40 years

- 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:

1. Smoking history of at least 10 pack years

2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30%
of the predicted normal value

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

Exclusion Criteria:

- Patients who have received systemic corticosteroids for a COPD exacerbation in the 6
weeks prior to screening or during the run-in period

- Patients requiring long-term oxygen therapy (> 15 hours a day) for chronic hypoxemia

- 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

- Any patient with active cancer or a history of cancer with less than 5 years
disease-free survival time

- Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured
at screening is prolonged

- Patients who have been vaccinated with live attenuated vaccines within 30 days prior
to screening or during the run-in period

- Patients unable to successfully use a dry powder inhaler device or perform spirometry
measurements

Other protocol-defined inclusion/exclusion criteria applied to the study.