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COMPLETEDPHASE3

The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Phase III Randomized, Double-blind, Placebo-controlled, 2-period Crossover, Multicenter Study to Assess the Effect of Indacaterol (300 μg o.d.) on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT00620022•Novartis

View on ClinicalTrials.gov

Summary

This study compared the effect of indacaterol (300 μg once daily \[od\]) on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure.
•Co-operative outpatients with a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD), as classified by the GOLD Guidelines (2006), and:
•* Smoking history of at least 20 pack years.
•* Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value.
•* Post-bronchodilator FEV1/forced vital capacity (FVC) \< 70%.

Exclusion Criteria

•Pregnant or nursing (lactating) women.
•Women of child-bearing potential.
•Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period.
•Patients requiring oxygen therapy or who experience oxygen desaturation to \< 80% during cycle exercise on room air.
•Patients with a Wmax value \< 20 W (as determined by the incremental cycle endurance test) at screening.
•Patients who have had a respiratory tract infection within 6 weeks prior to screening.
•Patients with contra-indications of cardiopulmonary exercise testing.
•Patients with concomitant pulmonary disease.
•Patients with a history (up to and including the screening visit) of asthma.
•Patients with diabetes Type I or uncontrolled diabetes Type II.
+5 more criteria

Locations (20)

Novartis Investigator Site

Torrance, California, United States

Novartis Investigator Site

Lebanon, New Hampshire, United States

Novartis Investigator Site

Brussels, Belgium

Novartis Investigator Site

Gembloux, Belgium

Novartis Investigator Site

Jette, Belgium

Novartis Investigator Site

Liège, Belgium

Novartis Investigator Site

Edmonton, Canada

Novartis Investigator Site

Kingston, Canada

Novartis Investigator Site

Aarhus, Denmark

Novartis Investigative Site

Hellerup, Denmark

Key Dates

Start Date

April 1, 2008

Primary Completion Date

January 1, 2009

Completion Date

January 1, 2009

Last Updated

August 17, 2011

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Indacaterol 300 μg

DRUG

Placebo

DRUG

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RECRUITINGPHASE3

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Inclusion Criteria

Exclusion Criteria

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