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Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease (INTRUST1)

22 de julio de 2011 actualizado por: 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)

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

1134

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania
        • Novartis Investigator Site
      • Cottbus, Alemania
        • Novartis Investigator Site
      • Donaustauf, Alemania
        • Novartis Investigator Site
      • Dortmund, Alemania
        • Novartis Investigator Site
      • Erfurt, Alemania
        • Novartis Investigator Site
      • Frankfurt, Alemania
        • Novartis Investigator Site
      • Gelnhausen, Alemania
        • Novartis Investigator Site
      • Grosshansdorf, Alemania
        • Novartis Investigator Site
      • Hannover, Alemania
        • Novartis Investigator Site
      • Heidelberg, Alemania
        • Novartis Investigator Site
      • Leipzig, Alemania
        • Novartis Investigator Site
      • Mainz, Alemania
        • Novartis Investigator Site
      • Neu-Ulm, Alemania
        • Novartis Investigator Site
      • Neuss, Alemania
        • Novartis Investigator Site
      • Potsdam, Alemania
        • Novartis Investigator Site
      • Rostock, Alemania
        • Novartis Investigator Site
      • Schwabach, Alemania
        • Novartis Investigator Site
      • Schwetzingen, Alemania
        • Novartis Investigator Site
      • Straussberg, Alemania
        • Novartis Investigator Site
      • Wiesbaden, Alemania
        • Novartis Investigative Site
      • Wuppertal, Alemania
        • Novartis Investigator Site
  • Argentina
      • Buenos Aires, Argentina
        • Novartis Investigative Site
      • Cordoba, Argentina
        • Novartis Investigative Site
      • Corrientes, Argentina
        • Novartis Investigative Site
      • Mendoza, Argentina
        • Novartis Investigative Site
      • Rosario, Argentina
        • Novartis Investigative Site
  • Australia
      • Box Hill, Australia
        • Novartis Investigator Site
      • Clayton, Australia
        • Novartis Investigator Site
      • Garran, Australia
        • Novartis Investigator Site
      • Glebe, Australia
        • Novartis Investigator Site
      • Kogarah, Australia
        • Novartis Investigator Site
      • Nedlands, Australia
        • Novartis Investigator Site
  • Colombia
      • Barranquilla, Colombia
        • Novartis Investigative Site
      • Bogota, Colombia
        • Novartis Investigative Site
      • Bogota, Colombia
        • Novartis Investigator Site
      • Medellin, Colombia
        • Novartis Investigative Site
  • Dinamarca
      • Copenhagen, Dinamarca
        • Novartis Investigator Site
      • Fredericia, Dinamarca
        • Novartis Investigator Site
      • Silkeborg, Dinamarca
        • Novartis Investigator Site
      • Soeborg, Dinamarca
        • Novartis Investigator Site
      • Vejle, Dinamarca
        • Novartis Investigator Site
  • España
      • Alicante, España
        • Novartis Investigative Site
      • Barcelona, España
        • Novartis Investigator Site
      • Begonte, España
        • Novartis Investigator Site
      • Cadiz, España
        • Novartis Investigator Site
      • Granollers, España
        • Novartis Investigator Site
      • Jaén, España
        • Novartis Investigative Site
      • La Coruna, España
        • Novartis Investigator Site
      • Leon, España
        • Novartis Investigator Site
      • Madrid, España
        • Novartis Investigator Site
      • Pamplona, España
        • Novartis Investigator Site
      • Torrelavega, España
        • Novartis Investigator Site
      • Valencia, España
        • Novartis Investigator Site
      • Vigo, España
        • Novartis Investigator Site
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 32509
        • Novartis Investigator Site
      • Mobile, Alabama, Estados Unidos, 36608
        • Novartis Investigator Site
    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85258
        • Novartis Investigative Site
      • Tucson, Arizona, Estados Unidos, 85723
        • Novartis Investigative Site
      • Tucson, Arizona, Estados Unidos, 85712
        • Novartis Investigative Site
    • Arkansas
      • Pine Bluff, Arkansas, Estados Unidos, 71603
        • Novartis Investigator Site
    • California
      • Fountain Valley, California, Estados Unidos, 92708
        • Novartis Investigator Site
      • Long Beach, California, Estados Unidos, 90822
        • Novartis Investigator Site
      • Los Angeles, California, Estados Unidos, 90095
        • Novartis Investigative Site
      • National City, California, Estados Unidos, 91950
        • Novartis Investigator Site
      • Palmdale, California, Estados Unidos, 93551
        • Novartis Investigator Site
      • Stockton, California, Estados Unidos, 95207
        • Novartis Investigative Site
      • Temecula, California, Estados Unidos, 92591
        • Novartis Investigator Site
    • Connecticut
      • Hartford, Connecticut, Estados Unidos, 06105-1208
        • Novartis Investigative Site
    • Florida
      • Clearwater, Florida, Estados Unidos, 33756
        • Novartis Investigative Site
      • Ft. Walton Beach, Florida, Estados Unidos, 32547
        • Novartis Investigator Site
      • Miami, Florida, Estados Unidos, 33136
        • Novartis Investigative Site
      • Miami, Florida, Estados Unidos, 331577
        • Novartis Investigative Site
      • Naranja, Florida, Estados Unidos, 33032
        • Novartis Investigative Site
      • Pensacola, Florida, Estados Unidos, 32514
        • Novartis Investigator Site
      • Sarasota, Florida, Estados Unidos, 34233
        • Novartis Investigator Site
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30342
        • Novartis Investigative Site
      • Conyers, Georgia, Estados Unidos, 30094
        • Novartis Investigator Site
    • Illinois
      • Normal, Illinois, Estados Unidos, 61761
        • Novartis Investigative Site
    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52240
        • Novartis Investigative Site
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • Novartis Investigative Site
      • Lenexa, Kansas, Estados Unidos, 66215
        • Novartis Investigative Site
      • Topeka, Kansas, Estados Unidos, 66606
        • Novartis Investigative Site
    • Louisiana
      • Lafayette, Louisiana, Estados Unidos, 70503
        • Novartis Investigator Site
      • Metaire, Louisiana, Estados Unidos, 70002
        • Novartis Investigator Site
      • New Orleans, Louisiana, Estados Unidos, 70119
        • Novartis Investigator Site
      • Slidell, Louisiana, Estados Unidos, 70458
        • Novartis Investigator Site
    • Maryland
      • Columbia, Maryland, Estados Unidos, 21044
        • Novartis Investigator Site
    • Massachusetts
      • Brockton, Massachusetts, Estados Unidos, 02301
        • Novartis Investigator Site
    • Michigan
      • Clarkston, Michigan, Estados Unidos, 48346
        • Novartis Investigator Site
      • Detroit, Michigan, Estados Unidos, 48202
        • Novartis Investigator Site
    • Missouri
      • St Charles, Missouri, Estados Unidos, 63301
        • Novartis Investigative Site
    • Montana
      • Missoula, Montana, Estados Unidos, 59808
        • Novartis Investigator Site
    • Nebraska
      • Boys Town, Nebraska, Estados Unidos, 68010
        • Novartis Investigator Site
      • Omaha, Nebraska, Estados Unidos, 68114
        • Novartis Investigative Site
      • Omaha, Nebraska, Estados Unidos, 68134
        • Novartis Investigative Site
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89119
        • Novartis Investigative Site
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756
        • Novartis Investigator Site
    • New Jersey
      • Asbury Park, New Jersey, Estados Unidos, 07712
        • Novartis Investigator Site
    • New York
      • Rochester, New York, Estados Unidos, 14618
        • Novartis Investigative Site
    • North Carolina
      • Mooresville, North Carolina, Estados Unidos, 28117
        • Novartis Investigator Site
      • Winston-Salem, North Carolina, Estados Unidos, 27103
        • Novartis Investigative Site
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74135-2920
        • Novartis Investigator Site
    • Oregon
      • Medford, Oregon, Estados Unidos, 97504
        • Novartis Investigative Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, Estados Unidos, 18020
        • Novartis Investigator Site
    • Rhode Island
      • Cumberland, Rhode Island, Estados Unidos, 02864
        • Novartis Investigative Site
    • South Carolina
      • Greenville, South Carolina, Estados Unidos, 29615
        • Novartis Investigator Site
      • Spartanburg, South Carolina, Estados Unidos, 29303
        • Novartis Investigative Site
    • Tennessee
      • Knoxville, Tennessee, Estados Unidos, 37919
        • Novartis Investigator Site
    • Texas
      • El Paso, Texas, Estados Unidos, 79903
        • Novartis Investigator Site
      • Houston, Texas, Estados Unidos, 77024
        • Novartis Investigative Site
      • Houston, Texas, Estados Unidos, 77079
        • Novartis Investigative Site
      • New Braunfels, Texas, Estados Unidos, 78130-6113
        • Novartis Investigative Center
    • Virginia
      • Newport News, Virginia, Estados Unidos, 23606
        • Novartis Investigator Site
      • Richmond, Virginia, Estados Unidos, 23225
        • Novartis Investigative Site
      • Richmond, Virginia, Estados Unidos, 23249
        • Novartis Investigator Site
  • Filipinas
      • Manila, Filipinas
        • Novartis Investigator Site
  • Guatemala
      • Guatemala, Guatemala
        • Novartis Investigative Site
      • Guatemala City, Guatemala
        • Novartis Investigative Site
  • México
      • Guadalajara, México
        • Novartis Investigative Site
      • Mexico City, México
        • Novartis Investigator Site
      • Monterrey, México
        • Novartis Investigative Site
      • Zapopan, México
        • Novartis Investigative Site
  • Pavo
      • Antalya, Pavo
        • Novartis Investigator Site
      • Canakkale, Pavo
        • Novartis Investigator Site
      • Isparta, Pavo
        • Novartis Investigator Site
      • Istanbul, Pavo
        • Novartis Investigator Site
      • Kartal, Pavo
        • Novartis Investigator Site
      • Kayseri, Pavo
        • Novartis Investigator Site
      • Kozlu / Zonguldak, Pavo
        • Novartis Investigator Site
      • Malatya, Pavo
        • Novartis Investigator Site
      • Manisa, Pavo
        • Novartis Investigator Site
      • Mecidiyekoy/Istanbul, Pavo
        • Novartis Investigator Site
      • Yenisehir/Izmir, Pavo
        • Novartis Investigator Site
  • Sudáfrica
      • Amanzimtoti, Sudáfrica
        • Novartis Investigator Site
      • Cape Town, Sudáfrica
        • Novartis Investigator Site
      • Johannesburg, Sudáfrica
        • Novartis Investigator Site
      • Midrand, Sudáfrica
        • Novartis Investigator Site
      • Umkomaas, Sudáfrica
        • Novartis Investigator Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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:

    1. Smoking history of at least 10 pack-years
    2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
    3. 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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Droga: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
Comparador activo: 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.
Droga: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
Droga: Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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)
Periodo de tiempo: From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)
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.
From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
Periodo de tiempo: 24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85)
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.
24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85)
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
Periodo de tiempo: From 5 minutes to 8 hours post-dose on Day 1
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.
From 5 minutes to 8 hours post-dose on Day 1
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2
Periodo de tiempo: 24 hours post-dose on Day 2
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.
24 hours post-dose on Day 2
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
Periodo de tiempo: From 5 minutes to 4 hours post-dose on Day 1
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.
From 5 minutes to 4 hours post-dose on Day 1
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)
Periodo de tiempo: From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)
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.
From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Novartis Pharmaceuticals

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2009

Finalización primaria (Actual)

1 de marzo de 2010

Finalización del estudio (Actual)

1 de marzo de 2010

Fechas de registro del estudio

Enviado por primera vez

15 de febrero de 2009

Primero enviado que cumplió con los criterios de control de calidad

15 de febrero de 2009

Publicado por primera vez (Estimar)

18 de febrero de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

18 de agosto de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

22 de julio de 2011

Última verificación

1 de julio de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CQAB149B2341

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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