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

NCT ID: NCT00422552

Last Updated: 2007-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Brief Summary

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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

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Indacaterol (QAB149)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigative site

Locations

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Novartis Investigative site

Horsham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CQAB149B2211

Identifier Type: -

Identifier Source: org_study_id