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

Phase 1

Completed

• Conditions: COPD

• Registration Number: NCT00422552
• Lead Sponsor: Novartis

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-01-16
• Study First Submitted QC: 2007-01-16
• Study First Posted: 2007-01-17
• Status Verified: 2007-06
• Last Update Submitted: 2007-06-21
• Last Update Posted: 2007-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change from baseline in IC and percent predicted FEV1 at various timepoints over 24 hours

Secondary Outcome Measures

Name	Time	Method
Percent predicted FEV1 time course change over 24 hours
Mean maximal change in IC time course change over 24 hours

Trial Locations

Locations (1)

Novartis Investigative site; 🇬🇧 Horsham, United Kingdom