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Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease | Clinical Trials | Clareo Health

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Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease

NCT00846586•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2007) and:
•1. Smoking history of at least 10 pack-years
•2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
•3. Post-bronchodilator FEV1/FVC (force vital capacity) \< 70%

Exclusion Criteria

•Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization 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 or during the run-in period
•Patients with a body mass index less than 15 or more than 40 kg/m\^2
•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

Locations (137)

Novartis Investigator Site

Birmingham, Alabama, United States

Novartis Investigator Site

Mobile, Alabama, United States

Novartis Investigative Site

Scottsdale, Arizona, United States

Novartis Investigative Site

Tucson, Arizona, United States

Novartis Investigative Site

Tucson, Arizona, United States

Novartis Investigator Site

Pine Bluff, Arkansas, United States

Novartis Investigator Site

Fountain Valley, California, United States

Novartis Investigator Site

Long Beach, California, United States

Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigator Site

National City, California, United States

Key Dates

Start Date

March 1, 2009

Primary Completion Date

March 1, 2010

Completion Date

March 1, 2010

Last Updated

August 18, 2011

Enrollment

1,134

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Indacaterol 150 μg

DRUG

Tiotropium 18 μg

DRUG

Placebo to indacaterol

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

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

NCT07382258

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

Mindful-Breath for People With COPD

NCT07195838

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 18, 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

Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease

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