- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00846586
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease (INTRUST1)
22 juillet 2011 mis à jour par: Novartis Pharmaceuticals
A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
1134
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Amanzimtoti, Afrique du Sud
- Novartis Investigator Site
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Cape Town, Afrique du Sud
- Novartis Investigator Site
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Johannesburg, Afrique du Sud
- Novartis Investigator Site
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Midrand, Afrique du Sud
- Novartis Investigator Site
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Umkomaas, Afrique du Sud
- Novartis Investigator Site
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Berlin, Allemagne
- Novartis Investigator Site
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Cottbus, Allemagne
- Novartis Investigator Site
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Donaustauf, Allemagne
- Novartis Investigator Site
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Dortmund, Allemagne
- Novartis Investigator Site
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Erfurt, Allemagne
- Novartis Investigator Site
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Frankfurt, Allemagne
- Novartis Investigator Site
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Gelnhausen, Allemagne
- Novartis Investigator Site
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Grosshansdorf, Allemagne
- Novartis Investigator Site
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Hannover, Allemagne
- Novartis Investigator Site
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Heidelberg, Allemagne
- Novartis Investigator Site
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Leipzig, Allemagne
- Novartis Investigator Site
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Mainz, Allemagne
- Novartis Investigator Site
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Neu-Ulm, Allemagne
- Novartis Investigator Site
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Neuss, Allemagne
- Novartis Investigator Site
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Potsdam, Allemagne
- Novartis Investigator Site
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Rostock, Allemagne
- Novartis Investigator Site
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Schwabach, Allemagne
- Novartis Investigator Site
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Schwetzingen, Allemagne
- Novartis Investigator Site
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Straussberg, Allemagne
- Novartis Investigator Site
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Wiesbaden, Allemagne
- Novartis Investigative Site
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Wuppertal, Allemagne
- Novartis Investigator Site
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Buenos Aires, Argentine
- Novartis Investigative Site
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Cordoba, Argentine
- Novartis Investigative Site
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Corrientes, Argentine
- Novartis Investigative Site
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Mendoza, Argentine
- Novartis Investigative Site
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Rosario, Argentine
- Novartis Investigative Site
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Box Hill, Australie
- Novartis Investigator Site
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Clayton, Australie
- Novartis Investigator Site
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Garran, Australie
- Novartis Investigator Site
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Glebe, Australie
- Novartis Investigator Site
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Kogarah, Australie
- Novartis Investigator Site
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Nedlands, Australie
- Novartis Investigator Site
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Barranquilla, Colombie
- Novartis Investigative Site
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Bogota, Colombie
- Novartis Investigative Site
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Bogota, Colombie
- Novartis Investigator Site
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Medellin, Colombie
- Novartis Investigative Site
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Copenhagen, Danemark
- Novartis Investigator Site
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Fredericia, Danemark
- Novartis Investigator Site
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Silkeborg, Danemark
- Novartis Investigator Site
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Soeborg, Danemark
- Novartis Investigator Site
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Vejle, Danemark
- Novartis Investigator Site
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Alicante, Espagne
- Novartis Investigative Site
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Barcelona, Espagne
- Novartis Investigator Site
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Begonte, Espagne
- Novartis Investigator Site
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Cadiz, Espagne
- Novartis Investigator Site
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Granollers, Espagne
- Novartis Investigator Site
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Jaén, Espagne
- Novartis Investigative Site
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La Coruna, Espagne
- Novartis Investigator Site
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Leon, Espagne
- Novartis Investigator Site
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Madrid, Espagne
- Novartis Investigator Site
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Pamplona, Espagne
- Novartis Investigator Site
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Torrelavega, Espagne
- Novartis Investigator Site
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Valencia, Espagne
- Novartis Investigator Site
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Vigo, Espagne
- Novartis Investigator Site
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Guatemala, Guatemala
- Novartis Investigative Site
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Guatemala City, Guatemala
- Novartis Investigative Site
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Guadalajara, Mexique
- Novartis Investigative Site
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Mexico City, Mexique
- Novartis Investigator Site
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Monterrey, Mexique
- Novartis Investigative Site
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Zapopan, Mexique
- Novartis Investigative Site
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Manila, Philippines
- Novartis Investigator Site
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Antalya, Turquie
- Novartis Investigator Site
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Canakkale, Turquie
- Novartis Investigator Site
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Isparta, Turquie
- Novartis Investigator Site
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Istanbul, Turquie
- Novartis Investigator Site
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Kartal, Turquie
- Novartis Investigator Site
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Kayseri, Turquie
- Novartis Investigator Site
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Kozlu / Zonguldak, Turquie
- Novartis Investigator Site
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Malatya, Turquie
- Novartis Investigator Site
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Manisa, Turquie
- Novartis Investigator Site
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Mecidiyekoy/Istanbul, Turquie
- Novartis Investigator Site
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Yenisehir/Izmir, Turquie
- Novartis Investigator Site
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Alabama
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Birmingham, Alabama, États-Unis, 32509
- Novartis Investigator Site
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Mobile, Alabama, États-Unis, 36608
- Novartis Investigator Site
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Arizona
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Scottsdale, Arizona, États-Unis, 85258
- Novartis Investigative Site
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Tucson, Arizona, États-Unis, 85723
- Novartis Investigative Site
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Tucson, Arizona, États-Unis, 85712
- Novartis Investigative Site
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Arkansas
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Pine Bluff, Arkansas, États-Unis, 71603
- Novartis Investigator Site
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California
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Fountain Valley, California, États-Unis, 92708
- Novartis Investigator Site
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Long Beach, California, États-Unis, 90822
- Novartis Investigator Site
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Los Angeles, California, États-Unis, 90095
- Novartis Investigative Site
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National City, California, États-Unis, 91950
- Novartis Investigator Site
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Palmdale, California, États-Unis, 93551
- Novartis Investigator Site
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Stockton, California, États-Unis, 95207
- Novartis Investigative Site
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Temecula, California, États-Unis, 92591
- Novartis Investigator Site
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Connecticut
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Hartford, Connecticut, États-Unis, 06105-1208
- Novartis Investigative Site
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Florida
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Clearwater, Florida, États-Unis, 33756
- Novartis Investigative Site
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Ft. Walton Beach, Florida, États-Unis, 32547
- Novartis Investigator Site
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Miami, Florida, États-Unis, 33136
- Novartis Investigative Site
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Miami, Florida, États-Unis, 331577
- Novartis Investigative Site
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Naranja, Florida, États-Unis, 33032
- Novartis Investigative Site
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Pensacola, Florida, États-Unis, 32514
- Novartis Investigator Site
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Sarasota, Florida, États-Unis, 34233
- Novartis Investigator Site
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Georgia
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Atlanta, Georgia, États-Unis, 30342
- Novartis Investigative Site
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Conyers, Georgia, États-Unis, 30094
- Novartis Investigator Site
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Illinois
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Normal, Illinois, États-Unis, 61761
- Novartis Investigative Site
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Iowa
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Iowa City, Iowa, États-Unis, 52240
- Novartis Investigative Site
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Kansas
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Kansas City, Kansas, États-Unis, 66160
- Novartis Investigative Site
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Lenexa, Kansas, États-Unis, 66215
- Novartis Investigative Site
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Topeka, Kansas, États-Unis, 66606
- Novartis Investigative Site
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Louisiana
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Lafayette, Louisiana, États-Unis, 70503
- Novartis Investigator Site
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Metaire, Louisiana, États-Unis, 70002
- Novartis Investigator Site
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New Orleans, Louisiana, États-Unis, 70119
- Novartis Investigator Site
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Slidell, Louisiana, États-Unis, 70458
- Novartis Investigator Site
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Maryland
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Columbia, Maryland, États-Unis, 21044
- Novartis Investigator Site
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Massachusetts
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Brockton, Massachusetts, États-Unis, 02301
- Novartis Investigator Site
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Michigan
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Clarkston, Michigan, États-Unis, 48346
- Novartis Investigator Site
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Detroit, Michigan, États-Unis, 48202
- Novartis Investigator Site
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Missouri
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St Charles, Missouri, États-Unis, 63301
- Novartis Investigative Site
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Montana
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Missoula, Montana, États-Unis, 59808
- Novartis Investigator Site
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Nebraska
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Boys Town, Nebraska, États-Unis, 68010
- Novartis Investigator Site
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Omaha, Nebraska, États-Unis, 68114
- Novartis Investigative Site
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Omaha, Nebraska, États-Unis, 68134
- Novartis Investigative Site
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Nevada
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Las Vegas, Nevada, États-Unis, 89119
- Novartis Investigative Site
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New Hampshire
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Lebanon, New Hampshire, États-Unis, 03756
- Novartis Investigator Site
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New Jersey
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Asbury Park, New Jersey, États-Unis, 07712
- Novartis Investigator Site
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New York
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Rochester, New York, États-Unis, 14618
- Novartis Investigative Site
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North Carolina
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Mooresville, North Carolina, États-Unis, 28117
- Novartis Investigator Site
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Winston-Salem, North Carolina, États-Unis, 27103
- Novartis Investigative Site
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Oklahoma
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Tulsa, Oklahoma, États-Unis, 74135-2920
- Novartis Investigator Site
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Oregon
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Medford, Oregon, États-Unis, 97504
- Novartis Investigative Site
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Pennsylvania
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Bethlehem, Pennsylvania, États-Unis, 18020
- Novartis Investigator Site
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Rhode Island
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Cumberland, Rhode Island, États-Unis, 02864
- Novartis Investigative Site
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South Carolina
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Greenville, South Carolina, États-Unis, 29615
- Novartis Investigator Site
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Spartanburg, South Carolina, États-Unis, 29303
- Novartis Investigative Site
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Tennessee
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Knoxville, Tennessee, États-Unis, 37919
- Novartis Investigator Site
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Texas
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El Paso, Texas, États-Unis, 79903
- Novartis Investigator Site
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Houston, Texas, États-Unis, 77024
- Novartis Investigative Site
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Houston, Texas, États-Unis, 77079
- Novartis Investigative Site
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New Braunfels, Texas, États-Unis, 78130-6113
- Novartis Investigative Center
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Virginia
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Newport News, Virginia, États-Unis, 23606
- Novartis Investigator Site
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Richmond, Virginia, États-Unis, 23225
- Novartis Investigative Site
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Richmond, Virginia, États-Unis, 23249
- Novartis Investigator Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) and:
- Smoking history of at least 10 pack-years
- Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
- Post-bronchodilator FEV1/FVC (force vital capacity) < 70%
Exclusion Criteria:
- Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization 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 or during the run-in period
- Patients with a body mass index less than 15 or more than 40 kg/m^2
- 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 applied to the study.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Indacaterol 150 μg and tiotropium 18 μg
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks.
Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI).
Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®).
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study.
The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
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Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
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Comparateur actif: Tiotropium 18 μg
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks.
Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI).
Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®).
Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study.
The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
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Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)
Délai: From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84).
Standardized FEV1 AUC was calculated by the trapezoidal rule.
The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
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From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
Délai: 24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85)
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85).
The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
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24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85)
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Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1
Délai: From 5 minutes to 8 hours post-dose on Day 1
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule.
The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
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From 5 minutes to 8 hours post-dose on Day 1
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Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2
Délai: 24 hours post-dose on Day 2
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
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24 hours post-dose on Day 2
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Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1
Délai: From 5 minutes to 4 hours post-dose on Day 1
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule.
The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
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From 5 minutes to 4 hours post-dose on Day 1
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Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)
Délai: From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of treatment (Week 12).
Standardized FEV1 AUC was calculated by the trapezoidal rule.
The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
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From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2009
Achèvement primaire (Réel)
1 mars 2010
Achèvement de l'étude (Réel)
1 mars 2010
Dates d'inscription aux études
Première soumission
15 février 2009
Première soumission répondant aux critères de contrôle qualité
15 février 2009
Première publication (Estimation)
18 février 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
18 août 2011
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 juillet 2011
Dernière vérification
1 juillet 2011
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Maladies pulmonaires
- Maladies pulmonaires obstructives
- Maladie pulmonaire obstructive chronique
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Parasympatholytiques
- Agents autonomes
- Agents du système nerveux périphérique
- Antagonistes cholinergiques
- Agents cholinergiques
- Agents bronchodilatateurs
- Agents anti-asthmatiques
- Agents du système respiratoire
- Bromure de tiotropium
Autres numéros d'identification d'étude
- CQAB149B2341
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Indacaterol 150 μg
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