Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations (SPARK)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01120691

First received: May 5, 2010

Last updated: October 17, 2012

Last verified: October 2012

History of Changes

Purpose

This study is designed to assess the effect of once-daily QVA149 on COPD exacerbations in patients with severe to very severe COPD.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Once-daily QVA149 Drug: once-daily NVA237 Drug: once-daily 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

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Superiority of QVA149 over NVA237 in terms of rate of COPD exacerbations [ Time Frame: 64 to 76 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Superiority of QVA149 over tiotropium in terms of rate of COPD exacerbations [ Time Frame: 64 to 76 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability of QVA149 versus NVA237 and tiotropium assessed by adverse events, electrocardiogram (ECG), laboratory tests, and vital signs [ Time Frame: 64 to 76 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	3843
Study Start Date:	April 2010
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: QVA149 QVA149	Drug: Once-daily QVA149
Active Comparator: NVA237 NVA237	Drug: once-daily NVA237
Active Comparator: open-label tiotropium open-label tiotropium	Drug: once-daily tiotropium

Eligibility

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

Criteria

Inclusion Criteria:

Male or female adults aged ≥40 yrs
Severe or very COPD [Stage III or IV as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008]
Smoking history of at least 10 pack years
Post-bronchodilator FEV1 < 50% of the predicted normal value and post- bronchodilator FEV1/FVC <70%
Documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics

Exclusion Criteria:

Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic hypoxemia
Patients who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1
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
Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120691

Show 346 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:	NCT01120691 History of Changes
Other Study ID Numbers:	CQVA149A2304, 2009-013256-69
Study First Received:	May 5, 2010
Last Updated:	October 17, 2012
Health Authority:	United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Federal Agency for Medicinal Products and Health Products Brazil: National Health Surveillance Agency Canada: Health Canada Chile: Comisión Nacional de Investigación Científica y Tecnológica Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Estonia: The State Agency of Medicine Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Guatemala: Ministry of Public Health and Social Assistance Hungary: National Institute of Pharmacy India: Drugs Controller General of India Ireland: Irish Medicines Board Israel: Ministry of Health Italy: The Italian Medicines Agency Korea: Food and Drug Administration Malaysia: Ministry of Health Mexico: Ministry of Health Netherlands: Medicines Evaluation Board (MEB) New Zealand: Food Safety Authority Norway: Norwegian Medicines Agency Peru: Ministry of Health Philippines: Bureau of Food and Drugs Poland: Ministry of Health Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Singapore: Health Sciences Authority South Africa: Department of Health Spain: Spanish Agency of Medicines Thailand: Food and Drug Administration Turkey: Ministry of Health Ukraine: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

QVA149
NVA237
COPD
exacerbation
combination bronchodilator

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

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