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NCT00845728

Exacerbation Study

Last Updated: 2013-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3439 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-07-31

Brief Summary

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This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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Indacaterol Tiotropium COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Indacaterol

Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)

Group Type EXPERIMENTAL

Indacaterol 150 µg

Intervention Type DRUG

Indacaterol 150 µg o.d. delivered via SDDPI

Tiotropium

Tiotropium 18 µg o.d. delivered via the handihaler®

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

Tiotropium 18 µg o.d. delivered via handihaler®

Interventions

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Indacaterol 150 µg

Indacaterol 150 µg o.d. delivered via SDDPI

Intervention Type DRUG

Tiotropium

Tiotropium 18 µg o.d. delivered via handihaler®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
* Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including:

1. Smoking history of at least 10 pack years, both current and ex-smokers are eligible
2. A documented history of at least 1 moderate or severe exacerbation in the previous 12 months

Exclusion Criteria

* Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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