Comparison of Indacaterol and Tiotropium on Lung Function and Related Outcomes in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Purpose

This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Indacaterol 150 µg Drug: Tiotropium	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium bromide Indacaterol

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Comparison of indacaterol 150 µg once daily (o.d.) versus tiotropium 18 µg o.d. with respect to trough forced expiratory volume in 1 second (FEV1). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of indacaterol 150 µg o.d. vs tiotropium 18 µg o.d. with regard to the rate of COPD exacerbations [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	3439
Study Start Date:	March 2009
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Indacaterol Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)	Drug: Indacaterol 150 µg Indacaterol 150 µg o.d. delivered via SDDPI
Active Comparator: Tiotropium Tiotropium 18 µg o.d. delivered via SDDPI	Drug: Tiotropium Tiotropium 18 µg o.d. delivered via SDDPI

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female adults aged ≥40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure
Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including:
1. Smoking history of at least 10 pack years, both current and ex-smokers are eligible
2. A documented history of at least 1 moderate or severe exacerbation in the previous 12 months

Exclusion Criteria:

Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation 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
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

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845728

Show 325 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00845728 History of Changes
Other Study ID Numbers:	CQAB149B2348
Study First Received:	February 15, 2009
Last Updated:	August 6, 2012
Health Authority:	United States: Food and Drug Administration Austria: Federal Office for Safety in Health Care Slovakia: State Institute for Drug Control Canada: Health Canada Israel: Ministry of Health Spain: Spanish Agency of Medicines Estonia: The State Agency of Medicine Lithuania: State Medicine Control Agency - Ministry of Health Finland: Finnish Medicines Agency Belgium: Federal Agency for Medicinal Products and Health Products United Kingdom: Medicines and Healthcare Products Regulatory Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) India: Drugs Controller General of India Hungary: National Institute of Pharmacy Iceland: Icelandic Medicines Control Agency Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Australia: Department of Health and Ageing Therapeutic Goods Administration Denmark: Danish Medicines Agency Czech Republic: State Institute for Drug Control Turkey: Ministry of Health Latvia: State Agency of Medicines Philippines: Bureau of Food and Drugs Russia: FSI Scientific Center of Expertise of Medical Application Germany: Federal Institute for Drugs and Medical Devices Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Portugal: National Authority of Medicines and Health Products (INFARMED, I.P.) Taiwan: Department of Health Sweden: Medical Products Agency Switzerland: Swissmedic Romania: National Medicines Agency Peru: Instituto Nacional de Salud Costa Rica: Ministry of Health Costa Rica Italy: The Italian Medicines Agency South Africa: Medicines Control Council China: Food and Drug Administration Venezuela: Ministry of Health and Social Development Brazil: National Health Surveillance Agency Thailand: Food and Drug Administration Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Novartis:

Indacaterol
Tiotropium
COPD

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013

Comparison of Indacaterol and Tiotropium on Lung Function and Related Outcomes in Patients With Chronic Obstructive Pulmonary Disease (COPD) (INVIGORATE)