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Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 µg o.d. Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 µg b.i.d. as Active Control

NCT00615030•Novartis

View on ClinicalTrials.gov

Summary

This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second \[FEV1\]) over the full 24-h time period

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 chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:
•Smoking history of at least 20 pack years
•Post-bronchodilator FEV1 \< 80% and ≥30% of the predicted normal value
•Post-bronchodilator FEV1/forced vital capacity (FVC) \< 70%

Exclusion Criteria

•Pregnant or lactating females
•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 (\>15 h a day)
•Patient who have had a respiratory tract infection 6 weeks prior to V2 (with further criteria)
•Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
•Patients with history of asthma (with further criteria)
•Patients with Type I or uncontrolled type II diabetes.
•Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
•Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
•Patient with a history with long QT syndrome or whose QTc interval is prolonged
+5 more criteria

Locations (7)

Novartis Investigative Site

Beuvry, France

Novartis Investigative Site

Nantes, France

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Hamburg, Germany

Novartis Investigative Site

Leipzig, Germany

Novartis Investigative Site

Mainz, Germany

Novartis Investigative Site

Barcelona, Spain

Key Dates

Start Date

January 1, 2008

Primary Completion Date

July 1, 2008

Completion Date

August 1, 2008

Last Updated

August 17, 2011

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Indacaterol

DRUG

Salmeterol

DRUG

Placebo to Indacaterol

DRUG

Placebo to Salmeterol

DRUG

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Chronic Obstructive Pulmonary Disease (COPD)

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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

Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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