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

October 29, 2013 updated by: Novartis Pharmaceuticals

A 64-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Effect of QVA149 (110/50 μg o.d.) vs NVA237 (50 μg o.d.) and Open-label Tiotropium (18 μg o.d.) on COPD Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

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

Study Overview

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2224

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina
    - Novartis Investigative Site
  - Buenos Aires, Argentina, 1428
    - Novartis Investigative Site
  - Buenos Aires, Argentina, B1842DID
    - Novartis Investigative Site
  - Buenos Aires, Argentina, B6500EZL
    - Novartis Investigative Site
  - Buenos Aires, Argentina, B8000XAV
    - Novartis Investigative Site
  - Buenos Aires, Argentina, C1013AAR
    - Novartis Investigative Site
  - Buenos Aires, Argentina, C1115AAB
    - Novartis Investigative Site
  - Buenos Aires, Argentina, C1122AAK
    - Novartis Investigative Site
  - Buenos Aires, Argentina, C1125ABE
    - Novartis Investigative Site
  - Buenos Aires, Argentina, C1186ACB
    - Novartis Investigative Site
  - Buenos Aires, Argentina, C1405BCH
    - Novartis Investigative Site
  - Buenos Aires, Argentina, C1425AUA
    - Novartis Investigative Site
  - Buenos Aires, Argentina, C1425BEA
    - Novartis Investigative Site
  - Buenos Aires, Argentina, C1440BRR
    - Novartis Investigative Site
  - Buenos aires, Argentina, B1878FNR
    - Novartis Investigative Site
  - Buenos aires, Argentina, B2705XAE
    - Novartis Investigative Site
  - Buenos aires, Argentina, C1120AAC
    - Novartis Investigative Site
  - Cordoba, Argentina, X5016KEH
    - Novartis Investigative Site
  - Corrientes, Argentina, 3400
    - Novartis Investigative Site
  - Mendoza, Argentina, 5500
    - Novartis Investigative Site
  - Mendoza, Argentina, M5500CCG
    - Novartis Investigative Site
  - Paraná Entre Ríos, Argentina, 3100
    - Novartis Investigative Site
  - Santa Fe, Argentina, S3000FIL
    - Novartis Investigative Site
- Buenos Aires
  - Capital Federal, Buenos Aires, Argentina, C1424BSF
    - Novartis Investigative Site
  - La Plata, Buenos Aires, Argentina, 1900
    - Novartis Investigative Site
  - Mar del Plata, Buenos Aires, Argentina, B7600FZN
    - Novartis Investigative Site
  - Mar del Plata, Buenos Aires, Argentina, 7600
    - Novartis Investigative Site
  - San Isidro, Buenos Aires, Argentina, B1609EEO
    - Novartis Investigative Site
- Santa Fe
  - Rosario, Santa Fe, Argentina, C2000DSR
    - Novartis Investigative Site
  - Rosario, Santa Fe, Argentina, S2000DBS
    - Novartis Investigative Site
- Tucuman
  - San Miguel de Tucuman, Tucuman, Argentina, 4000
    - Novartis Investigative Site
  - San Miguel de Tucuman, Tucuman, Argentina, T4000DGF
    - Novartis Investigative Site
Austria
- - Feldbach, Austria, 8330
    - Novartis Investigative Site
  - Grieskirchen, Austria, 4710
    - Novartis Investigative Site
  - Linz, Austria, 4020
    - Novartis Investigative Site
  - Salzburg, Austria, 5020
    - Novartis Investigative Site
  - Thalheim bei Wels, Austria, 4600
    - Novartis Investigative Site
Canada
- - Quebec, Canada, G1P 1J6
    - Novartis Investigative Site
- Alberta
  - Edmonton, Alberta, Canada, T6G 2B7
    - Novartis Investigative Site
- Ontario
  - Mississauga, Ontario, Canada, L5M 2V8
    - Novartis Investigative Site
  - Ottawa, Ontario, Canada, K1H 8L6
    - Novartis Investigative Site
- Quebec
  - Joliette, Quebec, Canada, J6E 6J2
    - Novartis Investigative Site
  - Laval, Quebec, Canada, H7S 2M5
    - Novartis Investigative Site
  - Montreal, Quebec, Canada, H2W 1T8
    - Novartis Investigative Site
  - Québec, Quebec, Canada, G1G 3Z4
    - Novartis Investigative Site
  - St-Romuald, Quebec, Canada, G6W 5M6
    - Novartis Investigative Site
  - Trois-Rivières, Quebec, Canada, G8T 7A1
    - Novartis Investigative Site
Colombia
- - Armenia, Colombia
    - Novartis Investigative Site
  - Barranquilla, Colombia
    - Novartis Investigative Site
  - Bogotá, Colombia
    - Novartis Investigative Site
  - Medellin, Colombia
    - Novartis Investigative Site
  - Medellín, Colombia
    - Novartis Investigative Site
- Cundinamarca
  - Bogota, Cundinamarca, Colombia
    - Novartis Investigative Site
Czech Republic
- - Cesky Krumlov, Czech Republic, 381 01
    - Novartis Investigative Site
  - Cvikov, Czech Republic, 471 54
    - Novartis Investigative Site
  - Havlickuv Brod, Czech Republic, 580 01
    - Novartis Investigative Site
  - Jaromer, Czech Republic, 551 01
    - Novartis Investigative Site
  - Karlovy Vary, Czech Republic, 360 66
    - Novartis Investigative Site
  - Kromeriz, Czech Republic, 767 55
    - Novartis Investigative Site
  - Kutna Hora, Czech Republic, 284 01
    - Novartis Investigative Site
  - Kyjov, Czech Republic, 697 01
    - Novartis Investigative Site
  - Liberec, Czech Republic, 460 01
    - Novartis Investigative Site
  - Pardubice, Czech Republic, 530 09
    - Novartis Investigative Site
  - Prague 4, Czech Republic, 142 00
    - Novartis Investigative Site
  - Praha 10, Czech Republic, 108 00
    - Novartis Investigative Site
  - Praha 9, Czech Republic, 198 00
    - Novartis Investigative Site
  - Rokycany, Czech Republic, 337 22
    - Novartis Investigative Site
  - Strakonice, Czech Republic, 38601
    - Novartis Investigative Site
  - Teplice, Czech Republic, 415 01
    - Novartis Investigative Site
  - Zatec, Czech Republic, 438 01
    - Novartis Investigative Site
  - Znojmo, Czech Republic, 669 02
    - Novartis Investigative Site
Denmark
- - Aalborg, Denmark, DK-9100
    - Novartis Investigative Site
  - Copenhagen NV, Denmark, DK-2400
    - Novartis Investigative Site
  - Hellerup, Denmark, DK-2900
    - Novartis Investigative Site
  - Hvidovre, Denmark, DK-2650
    - Novartis Investigative Site
  - Roskilde, Denmark, DK-4000
    - Novartis Investigative Site
  - Silkeborg, Denmark, 8600
    - Novartis Investigative Site
  - Sønderborg, Denmark, DK-6400
    - Novartis Investigative Site
Estonia
- - Tallinn, Estonia, 13419
    - Novartis Investigative Site
  - Tallinn, Estonia, 10138
    - Novartis Investigative Site
  - Tartu, Estonia, 51014
    - Novartis Investigative Site
Finland
- - Helsinki, Finland, 00029
    - Novartis Investigative Site
  - Jyvaskyla, Finland, 40100
    - Novartis Investigative Site
  - Turku, Finland, FIN-20100
    - Novartis Investigative Site
France
- - Bayonne Cedex, France, 64109
    - Novartis Investigative Site
  - Beuvry, France, 62660
    - Novartis Investigative Site
  - Ferolles-Attily, France, 77150
    - Novartis Investigative Site
  - Montpellier, France, 34059
    - Novartis Investigative Site
  - Paris, France, 75013
    - Novartis Investigative Site
Germany
- - Aschaffenburg, Germany, 63739
    - Novartis Investigative Site
  - Bamberg, Germany, 96049
    - Novartis Investigative Site
  - Berlin, Germany, 12043
    - Novartis Investigative Site
  - Berlin, Germany, 12203
    - Novartis Investigative Site
  - Berlin, Germany, 13086
    - Novartis Investigative Site
  - Berlin, Germany, 10717
    - Novartis Investigative Site
  - Berlin, Germany, 10117
    - Novartis Investigative Site
  - Berlin, Germany, 10367
    - Novartis Investigative Site
  - Berlin, Germany, 14050
    - Novartis Investigative Site
  - Berlin, Germany, 10969
    - Novartis Investigative Site
  - Berlin, Germany, 12165
    - Novartis Investigative Site
  - Berlin, Germany, D-12165
    - Novartis Investigative Site
  - Bochum, Germany, 44787
    - Novartis Investigative Site
  - Bonn, Germany, 53119
    - Novartis Investigative Site
  - Dresden, Germany, 01307
    - Novartis Investigative Site
  - Dueren, Germany, 52349
    - Novartis Investigative Site
  - Duisburg, Germany, 47057
    - Novartis Investigative Site
  - Frankfurt, Germany, 60596
    - Novartis Investigative Site
  - Freudenberg, Germany, 57258
    - Novartis Investigative Site
  - Fulda, Germany, 36039
    - Novartis Investigative Site
  - Gelsenkirchen, Germany, 45879
    - Novartis Investigative Site
  - Gummersbach, Germany, 51643
    - Novartis Investigative Site
  - Hagen, Germany, 59065
    - Novartis Investigative Site
  - Halle, Germany, 06108
    - Novartis Investigative Site
  - Hamburg, Germany, 20354
    - Novartis Investigative Site
  - Hamburg, Germany, 22299
    - Novartis Investigative Site
  - Hannover, Germany, 30167
    - Novartis Investigative Site
  - Heidelberg, Germany, 69117
    - Novartis Investigative Site
  - Homburg, Germany, 66424
    - Novartis Investigative Site
  - Kiel, Germany, 24148
    - Novartis Investigative Site
  - Langenfeld, Germany, 40764
    - Novartis Investigative Site
  - Leipzig, Germany, 04207
    - Novartis Investigative Site
  - Leipzig, Germany, 04357
    - Novartis Investigative Site
  - Lübeck, Germany, 23558
    - Novartis Investigative Site
  - Marburg, Germany, 35037
    - Novartis Investigative Site
  - Muenchen, Germany, 80331
    - Novartis Investigative Site
  - Nuernberg, Germany, 90419
    - Novartis Investigative Site
  - Oranienburg, Germany, 16515
    - Novartis Investigative Site
  - Potsdam, Germany, 14467
    - Novartis Investigative Site
  - Radebeul, Germany, 01445
    - Novartis Investigative Site
  - Reinfeld, Germany, 23858
    - Novartis Investigative Site
  - Saarbruecken, Germany, 66111
    - Novartis Investigative Site
  - Schwerte, Germany, 58239
    - Novartis Investigative Site
  - Schwetzingen, Germany, 68723
    - Novartis Investigative Site
  - Solingen, Germany, 42651
    - Novartis Investigative Site
  - Stade, Germany, 21680
    - Novartis Investigative Site
  - Teterow, Germany, 17166
    - Novartis Investigative Site
  - Wissen, Germany, 57537
    - Novartis Investigative Site
- NRW
  - Koblenz, NRW, Germany, 56068
    - Novartis Investigative Site
Greece
- - Athens, Greece, GR 11527
    - Novartis Investigative Site
  - Athens, Greece, GR 12461
    - Novartis Investigative Site
  - Athens, Greece, GR-106 76
    - Novartis Investigative Site
  - Athens - GR, Greece, 10676
    - Novartis Investigative Site
  - Larissa, Greece, 41110
    - Novartis Investigative Site
  - Thessaloniki, Greece, GR 570 10
    - Novartis Investigative Site
  - Thessaloniki, Greece, GR56403
    - Novartis Investigative Site
Hungary
- - Baja, Hungary, 6500
    - Novartis Investigative Site
  - Budapest, Hungary, 1125
    - Novartis Investigative Site
  - Cegled, Hungary, 2700
    - Novartis Investigative Site
  - Debrecen, Hungary, 4032
    - Novartis Investigative Site
  - Deszk, Hungary, 6772
    - Novartis Investigative Site
  - Eger, Hungary, 3300
    - Novartis Investigative Site
  - Makó, Hungary, 6900
    - Novartis Investigative Site
  - Mosonmagyarovar, Hungary, 9200
    - Novartis Investigative Site
  - Sopron, Hungary, 9400
    - Novartis Investigative Site
  - Szarvas, Hungary, 5540
    - Novartis Investigative Site
  - Szekszard, Hungary, 7100
    - Novartis Investigative Site
India
- - Nagpur - Maharastra, India, 400 012
    - Novartis Investigative Site
  - Panjim, India, 403002
    - Novartis Investigative Site
  - Secunderabad, India, 500002
    - Novartis Investigative Site
  - Trivandrum, India, 695011
    - Novartis Investigative Site
- A.p.
  - Hyderabad, A.p., India, 500 001
    - Novartis Investigative Site
- Andhra Pradesh
  - Hyderbabd, Andhra Pradesh, India, 500 029
    - Novartis Investigative Site
- Delhi
  - New Delhi, Delhi, India, 110029
    - Novartis Investigative Site
- Karnataka
  - Mysore, Karnataka, India, 570004
    - Novartis Investigative Site
- Maharashtra
  - Nashik, Maharashtra, India, 422005
    - Novartis Investigative Site
  - Pune, Maharashtra, India, 411 014
    - Novartis Investigative Site
- Rajasthan
  - Jaipur, Rajasthan, India, 302004
    - Novartis Investigative Site
- Tamil Nadu
  - Coimbatore, Tamil Nadu, India, 641014
    - Novartis Investigative Site
  - Coimbatore, Tamil Nadu, India, 641 002
    - Novartis Investigative Site
  - Coimbatore, Tamil Nadu, India, 641004
    - Novartis Investigative Site
Ireland
- - Dublin, Ireland
    - Novartis Investigative Site
  - Dublin 15, Ireland
    - Novartis Investigative Site
  - Dublin 24, Ireland
    - Novartis Investigative Site
  - Dublin 4, Ireland
    - Novartis Investigative Site
  - Dublin 9, Ireland
    - Novartis Investigative Site
Israel
- - Ashkelon, Israel, 78278
    - Novartis Investigative Site
  - Beer-Sheva, Israel, 84101
    - Novartis Investigative Site
  - Jerusalem, Israel, 91120
    - Novartis Investigative Site
  - Jerusalem, Israel, 91031
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  - Kfar-Sava, Israel, 44281
    - Novartis Investigative Site
  - Petach Tikva, Israel, 49100
    - Novartis Investigative Site
  - Ramat Gan, Israel, 52621
    - Novartis Investigative Site
  - Rehovot, Israel, 76100
    - Novartis Investigative Site
  - Tel-Aviv, Israel, 64239
    - Novartis Investigative Site
Italy
- - Pisa, Italy, 56124
    - Novartis Investigative Site
- AN
  - Osimo, AN, Italy, 60027
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- CT
  - Catania, CT, Italy, 95125
    - Novartis Investigative Site
- FG
  - Foggia, FG, Italy, 71100
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- FI
  - Firenze, FI, Italy, 50134
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- GE
  - Arenzano, GE, Italy, 16011
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- MI
  - Milano, MI, Italy, 20121
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- PD
  - Abano Terme, PD, Italy, 35031
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- PG
  - Perugia, PG, Italy, 06129
    - Novartis Investigative Site
- PI
  - Pisa, PI, Italy, 56124
    - Novartis Investigative Site
- PV
  - Pavia, PV, Italy, 27100
    - Novartis Investigative Site
- RM
  - Roma, RM, Italy, 00128
    - Novartis Investigative Site
- RN
  - Riccione, RN, Italy, 47838
    - Novartis Investigative Site
- SI
  - Siena, SI, Italy, 53100
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- SV
  - Pietra Ligure, SV, Italy, 17027
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- VI
  - Montecchio Maggiore, VI, Italy, 36075
    - Novartis Investigative Site
Mexico
- - San Luis Potosí, Mexico, 78218
    - Novartis Investigative Site
- Distrito Federal
  - Mexico, Distrito Federal, Mexico, 06726
    - Novartis Investigative Site
  - Mexico, Distrito Federal, Mexico, 14050
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- Jalisco
  - Guadalajara, Jalisco, Mexico, 44670
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  - Zapopan, Jalisco, Mexico, 45200
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- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64450
    - Novartis Investigative Site
Netherlands
- - Almelo, Netherlands, 7609 PP
    - Novartis Investigative Site
  - Breda, Netherlands, 4819 EV
    - Novartis Investigative Site
  - Dordrecht, Netherlands, 3318AT
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  - Drachten, Netherlands, 9200 DA
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  - Enschede, Netherlands, 7513 ER
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  - Harderwijk, Netherlands, 3840 AC
    - Novartis Investigative Site
  - Helmond, Netherlands, 5707 HA
    - Novartis Investigative Site
  - Hoofddorp, Netherlands, 2134 TM
    - Novartis Investigative Site
  - Hoorn, Netherlands, 1624 NP
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  - Leeuwarden, Netherlands, 8934 AD
    - Novartis Investigative Site
  - Roermond, Netherlands, 6043 CV
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  - Veldhoven, Netherlands, 5504 DB
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  - Voorburg, Netherlands, 2275 CX
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Peru
- Lima
  - Cercado de Lima, Lima, Peru, 01
    - Novartis Investigative Site
  - San Borja, Lima, Peru, 41
    - Novartis Investigative Site
  - San Isidro, Lima, Peru, 27
    - Novartis Investigative Site
  - San Martin de Porres, Lima, Peru, 31
    - Novartis Investigative Site
  - San Miguel, Lima, Peru, 32
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  - Santiago de Surco, Lima, Peru, 33
    - Novartis Investigative Site
Philippines
- - Bulacan, Philippines, 3020
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  - Las Pinas, Philippines, 1740
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  - Manila, Philippines
    - Novartis Investigative Site
  - Quezon City, Philippines, 1100
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- Metro Manila
  - Quezon City, Metro Manila, Philippines, 1109
    - Novartis Investigative Site
Poland
- - Bialystok, Poland, 15-010
    - Novartis Investigative Site
  - Katowice, Poland, 40-752
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  - Krakow, Poland, 30-067
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  - Krakow, Poland, 31-159
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  - Lublin, Poland, 20-637
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  - Mrozy, Poland, 05-320
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  - Warszawa, Poland, 01-456
    - Novartis Investigative Site
Puerto Rico
- - Humacao, Puerto Rico, 00791
    - Novartis Investigative Site
Russian Federation
- - Barnaul, Russian Federation, 656045
    - Novartis Investigative Site
  - Chelyabinsk, Russian Federation, 454021
    - Novartis Investigative Site
  - Ekaterinburg, Russian Federation, 620109
    - Novartis Investigative Site
  - Moscow, Russian Federation, 105229
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  - Moscow, Russian Federation, 127018
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  - Rostov-on-Don, Russian Federation, 344090
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  - Ryazan, Russian Federation, 390026
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  - S.-Petersburg, Russian Federation, 196247
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  - Samara, Russian Federation, 443079
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  - Sankt-Peterburg, Russian Federation, 197022
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  - St-Petersburg, Russian Federation, 193312
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  - St. Petersburg, Russian Federation, 191015
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  - St. Petersburg, Russian Federation, 194354
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  - St. Petersburg, Russian Federation, 198013
    - Novartis Investigative Site
  - St.Petersburg, Russian Federation, 198044
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  - Yaroslavl, Russian Federation, 150010
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- Tatarstan Republic
  - Kazan, Tatarstan Republic, Russian Federation, 420015
    - Novartis Investigative Site
Slovakia
- - Kosice, Slovakia, 040 01
    - Novartis Investigative Site
  - Kralovsky Chlmec, Slovakia, 077 01
    - Novartis Investigative Site
  - Martin, Slovakia, 03601
    - Novartis Investigative Site
  - Presov, Slovakia, 080 01
    - Novartis Investigative Site
  - Trnava, Slovakia, 917 75
    - Novartis Investigative Site
- Slovak Republic
  - Banska Bystrica, Slovak Republic, Slovakia, 975 17
    - Novartis Investigative Site
  - Bojnice, Slovak Republic, Slovakia, 972 01
    - Novartis Investigative Site
  - Humenne, Slovak Republic, Slovakia, 066 01
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  - Partizanske, Slovak Republic, Slovakia, 958 01
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South Africa
- - Durban, South Africa, 4001
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  - Newtown, Johannesburg, South Africa, 2193
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  - Pretoria, South Africa, 0181
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  - Pretoria, South Africa, 0184
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  - Pretoria, South Africa
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Spain
- - Alicante, Spain, 03114
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- Andalucia
  - Malaga, Andalucia, Spain, 29010
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- Cataluña
  - L'Hospitalet de Llobregat, Cataluña, Spain, 08907
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- Comunidad Valenciana
  - Valencia, Comunidad Valenciana, Spain
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- Galicia
  - La Coruna, Galicia, Spain, 15006
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United Kingdom
- - Blackpool, United Kingdom, FY3 8NR
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  - Bradford, United Kingdom, BD9 6RJ
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  - Bristol, United Kingdom, BS10 5NB
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  - Coventry, United Kingdom, CV6 4DD
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  - Gillingham, United Kingdom, ME7 5NY
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  - Glasgow, United Kingdom, G21 3UW
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  - Hereford, United Kingdom, HR1 2ER
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  - Huntingdon, United Kingdom, PE29 6NT
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  - London, United Kingdom, NW3 2PR
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  - Manchester, United Kingdom, M23 9QZ
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  - Merseyside, United Kingdom, CH49 5PE
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  - Portsmouth, United Kingdom, PO6 3AD
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  - Telford, United Kingdom, TF1 6TF
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  - Wolverhampton, United Kingdom, WV10 0QP
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- Cleveland
  - Stockton, Cleveland, United Kingdom, TS19 8PE
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- Nottingham
  - Sneinton, Nottingham, United Kingdom, NG3 7DQ
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- Somerset
  - Taunton, Somerset, United Kingdom, TA1 3JL
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- Surrey
  - Chertsey, Surrey, United Kingdom, KT16 0PZ
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United States
- Alabama
  - Birmingham, Alabama, United States, 35233
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  - Fairhope, Alabama, United States, 36532
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  - Florence, Alabama, United States, 35630
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  - Homewood, Alabama, United States, 35209-6870
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  - Jasper, Alabama, United States, 35501
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- Arkansas
  - Pine Bluff, Arkansas, United States, 71603
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- California
  - Fullerton, California, United States, 92835
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  - Palo Alto, California, United States, 94304-1207
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  - Riverside, California, United States, 92506
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  - San Diego, California, United States, 92101
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  - San Diego, California, United States, 92103-8415
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  - San Diego, California, United States, 92120
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  - Stockton, California, United States, 95207
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- Florida
  - Gainesville, Florida, United States, 32608
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  - Miami, Florida, United States, 33125
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  - Pensacola, Florida, United States, 32503
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- Idaho
  - Couer D'Alene, Idaho, United States, 83814
    - Novartis Investigative Site
- Illinois
  - Normal, Illinois, United States, 61761
    - Novartis Investigative Site
  - River Forest, Illinois, United States, 60305
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- Kentucky
  - Florence, Kentucky, United States, 41042
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  - Louisville, Kentucky, United States, 40206
    - Novartis Investigative Site
- Louisiana
  - Opelousas, Louisiana, United States, 70570
    - Novartis Investigative Site
- Maine
  - Bangor, Maine, United States, 04401
    - Novartis Investigative Site
- Minnesota
  - Fridley, Minnesota, United States, 55432
    - Novartis Investigative Site
- Missouri
  - Ozark, Missouri, United States, 65721
    - Novartis Investigative Site
  - St. Charles, Missouri, United States, 63301
    - Novartis Investigative Site
  - St. Louis, Missouri, United States, 63141
    - Novartis Investigative Site
- Montana
  - Missoula, Montana, United States, 59804
    - Novartis Investigative Site
- Nebraska
  - Papillion, Nebraska, United States, 68046
    - Novartis Investigative Site
- Nevada
  - Henderson, Nevada, United States, 89014
    - Novartis Investigative Site
  - Las Vegas, Nevada, United States, 89119
    - Novartis Investigative Site
  - Reno, Nevada, United States, 89520
    - Novartis Investigative Site
- New York
  - Great Neck, New York, United States, 11021
    - Novartis Investigative Site
  - Massapequa, New York, United States, 11758
    - Novartis Investigative Site
- North Carolina
  - Charlotte, North Carolina, United States, 28207
    - Novartis Investigative Site
  - Raleigh, North Carolina, United States, 27607
    - Novartis Investigative Site
  - Wilmington, North Carolina, United States, 28401
    - Novartis Investigative Site
- Ohio
  - Columbus, Ohio, United States, 43213
    - Novartis Investigative Site
- Oregon
  - Medford, Oregon, United States, 97504-8741
    - Novartis Investigative Site
  - Portland, Oregon, United States, 97213
    - Novartis Investigative Site
- Pennsylvania
  - Beaver, Pennsylvania, United States, 15009
    - Novartis Investigative Site
  - Erie, Pennsylvania, United States, 16508
    - Novartis Investigative Site
  - Pittsburgh, Pennsylvania, United States, 15243
    - Novartis Investigative Site
- South Carolina
  - Charleston, South Carolina, United States, 29406-7108
    - Novartis Investigative Site
  - Spartanburg, South Carolina, United States, 29303
    - Novartis Investigative Site
- Texas
  - Dallas, Texas, United States, 75216
    - Novartis Investigative Site
  - Dallas, Texas, United States, 75246
    - Novartis Investigative Site
  - Fort Worth, Texas, United States, 76107
    - Novartis Investigative Site
  - Ft. Worth, Texas, United States, 76104
    - Novartis Investigative Site
- Utah
  - Salt Lake City, Utah, United States, 84107
    - Novartis Investigative Site
- Virginia
  - Salem, Virginia, United States, 24153
    - Novartis Investigative Site
- Washington
  - Tacoma, Washington, United States, 98405
    - Novartis Investigative Site
- Wisconsin
  - Green Bay, Wisconsin, United States, 54311
    - Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria :

Male or female adults aged ≥40 years, who had signed an informed consent form prior to initiation of any study-related procedure.
Patients with severe to very severe Chronic Obstructive Pulmonary Disease COPD (Stage III or IV) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
Current or ex-smokers with a smoking history of at least 10 pack years (Ten pack-years were defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).
Patients with a post-bronchodilator Forced Expiratory Volume in one second ( FEV1) <50% of the predicted normal value, and post-bronchodilator FEV1/ Forced Vital Capacity (FVC) <0.70 at Visit 2 (day -14). (Post refers to 1 h after sequential inhalation of 84 µg (or equivalent dose) of ipratropium bromide and 400 µg of salbutamol).
A documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and/or antibiotics.

Exclusion Criteria:

Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
Women of child-bearing potential
Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic hypoxemia.
Patients who had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to visit 1 or between visit 1 (Day -21) and Visit 3 (Day 1).
Patients who developed a COPD exacerbation during a period between visit 1 and 3 were ineligible but were permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
Patients who had a respiratory tract infection within 4 weeks prior to visit 1 (Day -21)
• Patients who developed an upper or lower respiratory tract infection during the screening period (up to visit 3 (Day 1) were not eligible, but were permitted to be re-screened 4 weeks after the resolution of the respiratory tract infection
Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active), clinically significant bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension.
Patients with lung lobectomy, or lung volume reduction or lung transplantation.
Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to):
- Unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable Atrial Fibrillation (AF). Patients with such events not considered clinically significant by the investigator may be considered for inclusion in the study
- history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- uncontrolled hypo- or hyperthyroidism, hypokalemia or hyper adrenergic state
- narrow-angle glaucoma
- Symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention. (Patients with a Transurethral Resection of Prostate (TURP) were excluded from the study. Patients who underwent full re-section of the prostate could be considered for the study, as well as patients who were asymptomatic and stable on pharmacological treatment for the condition).
- any condition which might have compromised patient safety or compliance, interfered with evaluation, or precluded completion of the study
Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm3 (at visit 2), or onset of symptoms prior to 40 years. Patients without asthma were excluded if their eosinophil count was >600/mm3 at visit 2.
Patients with allergic rhinitis who used H1 antagonists or intranasal corticosteroids intermittently (treatment with a constant dose was permitted).
Patients with eczema (atopic), known high immunoglobulin E (IgE) levels or a known positive skin prick test in the last 5 years.
Patients with known history and diagnosis of alpha-1 antitrypsin deficiency.
Patients who were participating in the active phase of a supervised pulmonary rehabilitation program.
Patients with Type I or uncontrolled Type II diabetes.
Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs or drugs of a similar class or any component thereof:
- anticholinergic agents
- long and short acting beta-2 agonists
- sympathomimetic amines.
Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at visit 2 (Day -14) (Fridericia method) was prolonged (>450 ms for males and females) as confirmed by the central ECG assessor.
Patients with a clinically significant abnormality on the screening or baseline ECG who in the judgment of the investigator would be at potential risk if enrolled into the study. (These patients could not be re-screened).
Patients who needed treatments for COPD and allied conditions after the start of the study (visit 1)
Patients who needed treatments for COPD and allied conditions (e.g. allergic rhinitis) unless they had been stabilized
Patients taking other prohibited medications
Patients unable to use a dry powder inhaler (e.g. single dose dry powder inhaler (SDDPI), HandiHaler® device, or pressurized Metered Dose Inhaler (MDI) (rescue medication).
Patients unable to use an electronic patient diary.
Patients who were, in the opinion of the investigator known to be unreliable or non-compliant.
Patients who used other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of visit 1 (day -21), whichever was longer.
Patients who had live attenuated vaccination within 30 days prior to the screening visit or during the run-in period. Inactivated influenza vaccination, pneumococcal vaccination or any other inactivated vaccine was acceptable provided it was not administered within 48 hours prior to screening and randomization visits.

No additional exclusions were applied by the investigator, in order to ensure that the study population was representative of all eligible patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QVA149 QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.	Drug: QVA149 QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Drug: Salbutamol/albuterol As needed throughout the study
Active Comparator: NVA237 NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.	Drug: Salbutamol/albuterol As needed throughout the study Drug: NVA237 NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).
Active Comparator: open-label tiotropium Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.	Drug: Salbutamol/albuterol As needed throughout the study Drug: tiotropium Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period. Time Frame: 64 weeks	A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization. Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years	64 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and Open-label Tiotropium Treatment Arms During the Treatment Period. Time Frame: 76 weeks	A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization. Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years	76 weeks
Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Between QVA149, NVA237 and Open Label Tiotropium During the Treatment Period Time Frame: 64 weeks	A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as a worsening of two or more of the following major symptoms for at least 2 consecutive days: dyspnea, sputum volume or sputum purulence OR a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: sore throat, colds (nasal discharge and/or nasal congestion), fever without other cause, cough or wheezing. A COPD exacerbation was considered of moderate severity if treatment with systemic glucocorticosteroids or antibiotics or both was required and severe if hospitalization was required. An emergency room (ER) visit of longer than 24 hours was considered a hospitalization. Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years	64 weeks
Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Requiring the Use of Both Systemic Glucocorticosteroids and Antibiotics Time Frame: 64 weeks	Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years	64 weeks
Number of Days With Moderate or Severe Exacerbation That Required Treatment With Systemic Corticosteroids and Antibiotics Time Frame: 64 weeks	The number of exacerbation days is defined as the sum of the duration of days recorded as an exacerbation for all exacerbations recorded per patient.	64 weeks
Time to Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.) During the Treatment Period. Time Frame: 64 weeks	Time to Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.	64 weeks
Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.)During the Treatment Period Time Frame: 64 weeks	Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason was analyzed for each treatment group using a Kaplan-Meier estimation for the modified safety set. Patients who did not discontinue early were censored at the final visit of the treatment phase.	64 weeks
Cumulative Rates of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations for Multiple COPD Exacerbation at Different Time Points Time Frame: 26, 52, 64, 76 weeks	Cumulative rates were estimated using Anderson and Gill method. Chronic Obstructive Pulmonary Disease (COPD) exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if treatment for moderate severity and hospitalization were required. Rate of moderate or severe exacerbations per year = total number of moderate or severe exacerbations / total number of treatment years	26, 52, 64, 76 weeks
Pre-dose Forced Expiratory Volume in 1 Second (FEV-1) After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium Time Frame: 4, 12, 26, 38, 52 and 64 weeks	Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards. Spirometry measurements taken were FEV1 at -45 minutes and -15 minutes pre-dose. Three acceptable maneuvers had to be performed for each time point. The FEV1 values recorded had to be the highest values measured irrespective of whether or not they occurred on the same curve. The mixed model for analysis contained treatment as a fixed effect with average of the 45 minutes and 15 minutes pre dose FEV1 measurements at day 1 as the baseline measurement, FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at -14 Day) as covariates.	4, 12, 26, 38, 52 and 64 weeks
Pre-dose Forced Vital Capacity (FVC)After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium Time Frame: 4, 12, 26, 38, 52 and 64 weeks	Pulmonary function assessments were performed using centralized spirometry. The spirometer was customized and programmed according to the requirements of the study protocol in accordance with American Thoracic Society (ATS) standards. Pre-dose Forced Vital Capacity (FVC) is defined as the average of the -15 minutes and the -45 minutes FVC values. Baseline is defined as the average of the -45 minutes and -15 minutes FVC values taken on day 1 prior to first dose. FVC data taken within 6h of rescue medication or within 7 days of systemic corticosteroid is excluded from this analysis	4, 12, 26, 38, 52 and 64 weeks
Change in Mean Daily Use (Number of Puffs) of Rescue Therapy Between QVA149, NVA237 and Open Label Tiotropium From Baseling Over the 64 Week Treatment Period Time Frame: Baseline (14 day run-in), 64 weeks	The severe or less FEV1 % predicted (post bronchodilator)>=30%; very severe=> FEV1 % predicted(the post bronchodilator)<30%.Number of puffs of rescue medication taken in the previous 12 hours was recorded in patient diary in the morning and in the evening for 26 weeks.The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient.Rescue medication data recorded during the 14 day run-in was used to calculate the baseline.A negative change from baseline indicates improvement. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates.	Baseline (14 day run-in), 64 weeks
Change From Baseline of Percentage of Days Without Rescue Therapy Use Between QVA149,NVA237 and Open Label Tiotropium Over the 64 Week Treatment Period Time Frame: Baseline (14 day run-in), 64 weeks	A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. The percentage of days is calculated by the number of days with no rescue medicine use/total number of days with evaluable data X 100. A mixed model was used with treatment as a fixed effect with baseline number of puffs and FEV1 prior to inhalation and FEV1 60 minutes post inhalation of two short acting bronchodilators (components of reversibility at Day -14) as covariates. The model also included baseline smoking status (current/ex-smoker), baseline ICS use (Yes/No) and region as fixed effects with center nested within region as a random effect.	Baseline (14 day run-in), 64 weeks
St. George's Respiratory Questionnaire (SGRQ) Scores Between QVA149, NVA237 and Open Label Tiotropium Over 12, 26, 38, 52 and 64 Weeks of Treatment Time Frame: 12, 26, 38, 52 and 64 weeks	St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Mixed model used baseline SGRQ, baseline inhaled corticosteroid (ICS) use, Forced Expiratory Volume in 1 Second (FEV1) prior to inhalation of short acting beta-agonist (SABA), and FEV1 45 minutes post-inhalation of SABA as covariates. SGRQ total score is the sum of the scores from the three components; symptoms, activity and impacts.	12, 26, 38, 52 and 64 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Wedzicha JA, Decramer M, Ficker JH, Niewoehner DE, Sandstrom T, Taylor AF, D'Andrea P, Arrasate C, Chen H, Banerji D. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013 May;1(3):199-209. doi: 10.1016/S2213-2600(13)70052-3. Epub 2013 Apr 23.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

May 5, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 11, 2010

Study Record Updates

Last Update Posted (Estimate)

December 2, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

CQVA149A2304
2009-013256-69 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on QVA149

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