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

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 & 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Formoterol Fumarate; 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

• 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