26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) | NCT00463567 | Trialant

26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) | NCT00463567 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility 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

Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and:

Smoking history of at least 20 pack years

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

Post-bronchodilator FEV1/FVC < 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol)

Exclusion Criteria:

Pregnant or lactating females

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

Patients requiring long term oxygen therapy (> 15 h a day)

Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria)

Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis

Patients with a history of asthma (with further criteria)

Patients with Type I or uncontrolled Type II diabetes

Patients with contraindications for tiotropium

Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality

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 is prolonged

Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures

Patients who have had treatment with the investigational drug (with further criteria)

Patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period

Patients with known history of non compliance to medication

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

Other protocol-defined inclusion/exclusion criteria may apply