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A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

A Phase III, Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, 3-period Incomplete Block, Multidose Crossover Study to Determine the Effect on Lung Function of Indacaterol (150 and 300 μg o.d.) in Patients With Moderate to Severe COPD, Using Tiotropium (18 μg o.d.) as an Active Control

NCT00615459•Novartis

View on ClinicalTrials.gov

Summary

The study compared the 24-hour spirometry profile of indacaterol with that of placebo and with tiotropium as an active control in patients with 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 out patients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:
•1. Smoking history of at least 10 pack years (current or previous smokers)
•2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥30% of the predicted normal value.
•3. Post-bronchodilator FEV1/Forced vital capacity (FVC) \< 70%

Exclusion Criteria

•Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
•Patients requiring long-term oxygen therapy for chronic hypoxemia
•Patients who have had a respiratory tract infection within 6 weeks prior to Visit
•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
•Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
•Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at Visit 1 or randomization is prolonged
•Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
+1 more criteria

Locations (20)

Novartis Investigative site

Camperdown, Australia

Novartis Investigator Site

Gauting, Germany

Novartis Investigator Site

Großhansdorf, Germany

Novartis Investigator Site

Mainz, Germany

Novartis Investigator site

Marburg, Germany

Novartis Investigator Site

Wiesbaden, Germany

Novartis Investigator Site

Almelo, Netherlands

Novartis Investigator Site

Breda, Netherlands

Novartis Investigator Site

Eindhoven, Netherlands

Novartis Investigator Site

Harderwijk, Netherlands

Key Dates

Start Date

February 1, 2008

Primary Completion Date

December 1, 2008

Completion Date

December 1, 2008

Last Updated

August 17, 2011

Enrollment

169

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Indacaterol

DRUG

Tiotropium

DRUG

Placebo

DRUG

cfMSC Stem Cell Therapy Targeting COPD

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A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

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Chronic Obstructive Pulmonary Disease (COPD)

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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

A Crossover Study to Determine the Effect on Lung Function of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A