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

COMPLETEDPHASE3

Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A 12-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (150 and 300 µg Once Daily [od]) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00794157•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily \[od\]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and:
•1. Smoking history of at least 20 pack-years.
•2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value.
•3. Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%.

Exclusion Criteria

•Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the 14 day run-in period prior to randomization.
•Patients requiring long-term oxygen therapy (\> 15 hours a day) for chronic hypoxemia.
•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.
•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 screening 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 (60)

Novartis Investigator Site

Hong Kong, Hong Kong

Novartis Investigator Site

New Territories, Hong Kong

Novartis Investigative Site

Ahmedabad, India

Novartis Investigator Site

Bangalore, India

Novartis Investigative Site

Coimbatore, India

Novartis Investigator Site

Coimbatore, India

Novartis Investigator Site

India, India

Novartis Investigative Site

Mumbai, India

Novartis Investigative Center

Panjim, India

Novartis Investigative Site

Asahikawa, Japan

Key Dates

Start Date

November 1, 2008

Primary Completion Date

October 1, 2009

Completion Date

October 1, 2009

Last Updated

August 17, 2011

Enrollment

347

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Indacaterol 150 μg capsules

DRUG

Indacaterol 300 μg capsules

DRUG

Placebo capsules

DRUG

cfMSC Stem Cell Therapy Targeting COPD

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RECRUITINGNA

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NCT07382258

Chronic Obstructive Pulmonary Disease (COPD)

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Mindful-Breath for People With 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

Confirmatory Study of Indacaterol 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