Effect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the change in inspiratory capacity and lung function in patients with chronic obstructive pulmonary disease when treated with indacaterol compared to placebo and formoterol.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Formoterol Fumarate

Criteria

Inclusion Criteria:

• Male and post-menopausal female adults aged 40-80 years inclusive.

• Patients with a clinical diagnosis of COPD according to the Global Initiative for Chronic Lung Disease (GOLD) Guidelines (2005)

• Smoking history of at least 10 pack years (either smokers or ex-smokers).

• Able to perform reproducible spirometry maneuvers.

• Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.

Exclusion Criteria:

• COPD exacerbations within 6 weeks prior to dosing

• Concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.

• Medical conditions that would interfere with the performance of spirometry or may pose a potential hazard from performing spirometry.

• Any other medical condition that in the opinion of the Investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease.

• Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.

Other protocol-defined inclusion/exclusion criteria may apply