QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Purpose

The purpose of this study is to compare the efficacy and safety/tolerbility of QVA149 (fixed-dose combination of indacaterol and NVA237)with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: QVA149 Drug: fluticasone/salmeterol	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 26-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe COPD

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

To demonstrate the superiority of once-daily QVA149 as compared to twice-daily fluticasone/salmeterol in terms of forced expiratory volume in one second (FEV1) area under the curve for 0-12 hours (AUC0-12h) in patients with moderate to severe COPD. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the effect of QVA149 as compared to fluticasone/salmeterol in terms of standardized FEV1 AUC0-12h. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the effect of QVA149 as compared to fluticasone/salmeterol in terms of safety and tolerability as measured by adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	523
Study Start Date:	March 2011
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: QVA149 QVA149, delivered once daily via single-dose dry powder inhaler (SDDPI)	Drug: QVA149
Active Comparator: fluticasone/salmeterol (Seretide) fluticasone/salmeterol (Seretide®) delivered twice daily via the Accuhaler®	Drug: fluticasone/salmeterol

Eligibility

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

Criteria

Inclusion Criteria:

Smoking history of at least 10 pack years
Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2009)
Post-bronchodilator FEV1 < 80% and ≥ 40% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular co-morbid conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01315249

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Locations

Belgium
Novartis Investigative Site
Aalst, Belgium
Novartis Investigative Site
Bruxelles, Belgium
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Chênée, Belgium
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Genk, Belgium
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Hasselt, Belgium
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Herentals, Belgium
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Jambes, Belgium
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Jette, Belgium
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Malmédy, Belgium
Czech Republic
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Cvikov, Czech Republic
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Melnik, Czech Republic
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Pardubice, Czech Republic
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Praha, Czech Republic
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Teplice, Czech Republic
Estonia
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Tallinn, Estonia
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Tartu, Estonia
Germany
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Aschaffenburg, Germany
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Bad Wörishofen, Germany
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Bamberg, Germany
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Berlin, Germany
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Bielefeld, Germany
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Bochum, Germany
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Bonn, Germany
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Borstel, Germany
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Dortmund, Germany
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Düren, Germany
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Eschwege, Germany
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Frankfurt am Main, Germany
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Freudenberg, Germany
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Fulda, Germany
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Fürstenwalde, Germany
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Gelsenkirchen, Germany
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Gummersbach, Germany
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Göttingen, Germany
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Güstrow, Germany
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Hagen, Germany
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Hamburg, Germany
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Hannover, Germany
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Hildesheim, Germany
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Leipzig, Germany
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Lübeck, Germany
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Marburg, Germany
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München, Germany
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München, Germany
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Oschersleben, Germany
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Ratingen, Germany
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Rheine, Germany
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Saarbrücken, Germany
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Solingen, Germany
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Ulm, Germany
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Wissen, Germany
Hungary
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Budapest, Hungary
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Cegled, Hungary
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Eger, Hungary
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Godollo, Hungary
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Gyor, Hungary
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Mosonmagyarovar, Hungary
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Szarvas, Hungary
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Szeged, Hungary
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Torokbalint, Hungary
Lithuania
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Alytus, Lithuania
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Kaunas, Lithuania
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Klaipeda, Lithuania
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Utena, Lithuania
Norway
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Kongsvinger, Norway
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Skedsmokorset, Norway
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Stavanger, Norway
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Trondheim, Norway
Novartis Investigative Site
Ålesund, Norway

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01315249 History of Changes
Other Study ID Numbers:	CQVA149A2313, 2010-023621-37
Study First Received:	March 11, 2011
Last Updated:	April 17, 2012
Health Authority:	United States: Food and Drug Administration Belgium: Federal Agency for Medicines and Health Products, FAMHP Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board Belgium: Ministry of Social Affairs, Public Health and the Environment Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Czech Republic: Ethics Committee Czech Republic: State Institute for Drug Control Estonia: The State Agency of Medicine Hungary: National Institute of Pharmacy Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices Germany: Federal Ministry of Education and Research Germany: Federal Ministry of Food, Agriculture and Consumer Protection Germany: German Institute of Medical Documentation and Information Germany: Ministry of Health Germany: Paul-Ehrlich-Institut Korea: Food and Drug Administration Lithuania: Bioethics Committee Lithuania: State Medicine Control Agency - Ministry of Health South Korea: Institutional Review Board South Korea: Korea Food and Drug Administration (KFDA) Norway: Data Protection Authority Norway: Directorate of Health Norway: Norwegian Institute of Public Health Norway: Norwegian Medicines Agency Norway: Norwegian Social Science Data Services Norway: The National Committees for Research Ethics Spain: Comité Ético de Investigación Clínica Spain: Ethics Committee Spain: Ministry of Health Spain: Ministry of Health and Consumption Spain: Spanish Agency of Medicines

Keywords provided by Novartis:

QVA149
indacaterol
NVA237
COPD
Fluticasone/Salmeterol

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Salmeterol
Albuterol
Fluticasone
Fluticasone, salmeterol drug combination
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on June 18, 2013

QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) (ILLUMINATE)