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Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control

NCT00567996•Novartis

View on ClinicalTrials.gov

Summary

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:
•Smoking history of at least 20 pack years
•Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) \< 80% predicted and \>or= 30% of predicted normal value
•Post-bronchodilator FEV1/FVC \< 70%
•("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)

Exclusion Criteria

•Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception
•Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in
•Patients requiring oxygen therapy for chronic hypoxemia (typically \>15h/day)
•Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period
•Concomitant pulmonary disease
•Asthma history (eosinophils \> 400/mm3; symptoms prior to age 40). Includes history of childhood asthma
•History of long QTc syndrome or QTc interval \> 450 ms for males and \>470 ms for females
•Patients who have a clinically significant condition or a clinically relevant laboratory abnormality
•History of reactions to sympathomimetic amines or inhaled medication
•Inability to use the dry powder devices or perform spirometry
+3 more criteria

Locations (128)

Novartis Investigative Site

Edmonton, Canada

Novartis Investigator Site

Edmonton, Canada

Novartis Investigator Site

London, Canada

Novartis Investigator Site

Mirabel, Canada

Novartis Investigator Site

Montreal, Canada

Novartis Investigator Site

Toronto, Canada

Novartis Investigator site

Barranquilla, Colombia

Novartis Investigator Site

Bogota D.C., Colombia

Novartis Investigator Site

Medellín, Colombia

Novartis Investigator Site

Cvikov, Czechia

Key Dates

Start Date

November 1, 2007

Primary Completion Date

January 1, 2009

Last Updated

August 18, 2011

Enrollment

1,002

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Indacaterol 150 μg

DRUG

Salmeterol 50 μg

DRUG

Placebo to Indacaterol

DRUG

Placebo to Salmeterol

DRUG

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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 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 in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as 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