A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via the TWISTHALER® Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.

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

Details

• Lead Sponsor: Novartis
• Collaborator: Schering-Plough
• Treatments: Albuterol; Formoterol Fumarate

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 (which include any adjustment to their current COPD treatment)

• Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and:

• Smoking history of at least 10 pack years

• Post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% and ≥30% of the predicted normal value.

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

Exclusion Criteria:

• Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.

• Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.

• Patients with a history of asthma.

• Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.

• Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.

Other protocol-defined inclusion/exclusion criteria may apply.