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

22 de julho de 2011 atualizado 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)

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

1134

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha
        • Novartis Investigator Site
      • Cottbus, Alemanha
        • Novartis Investigator Site
      • Donaustauf, Alemanha
        • Novartis Investigator Site
      • Dortmund, Alemanha
        • Novartis Investigator Site
      • Erfurt, Alemanha
        • Novartis Investigator Site
      • Frankfurt, Alemanha
        • Novartis Investigator Site
      • Gelnhausen, Alemanha
        • Novartis Investigator Site
      • Grosshansdorf, Alemanha
        • Novartis Investigator Site
      • Hannover, Alemanha
        • Novartis Investigator Site
      • Heidelberg, Alemanha
        • Novartis Investigator Site
      • Leipzig, Alemanha
        • Novartis Investigator Site
      • Mainz, Alemanha
        • Novartis Investigator Site
      • Neu-Ulm, Alemanha
        • Novartis Investigator Site
      • Neuss, Alemanha
        • Novartis Investigator Site
      • Potsdam, Alemanha
        • Novartis Investigator Site
      • Rostock, Alemanha
        • Novartis Investigator Site
      • Schwabach, Alemanha
        • Novartis Investigator Site
      • Schwetzingen, Alemanha
        • Novartis Investigator Site
      • Straussberg, Alemanha
        • Novartis Investigator Site
      • Wiesbaden, Alemanha
        • Novartis Investigative Site
      • Wuppertal, Alemanha
        • 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
  • Austrália
      • Box Hill, Austrália
        • Novartis Investigator Site
      • Clayton, Austrália
        • Novartis Investigator Site
      • Garran, Austrália
        • Novartis Investigator Site
      • Glebe, Austrália
        • Novartis Investigator Site
      • Kogarah, Austrália
        • Novartis Investigator Site
      • Nedlands, Austrália
        • Novartis Investigator Site
  • Colômbia
      • Barranquilla, Colômbia
        • Novartis Investigative Site
      • Bogota, Colômbia
        • Novartis Investigative Site
      • Bogota, Colômbia
        • Novartis Investigator Site
      • Medellin, Colômbia
        • 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
  • Espanha
      • Alicante, Espanha
        • Novartis Investigative Site
      • Barcelona, Espanha
        • Novartis Investigator Site
      • Begonte, Espanha
        • Novartis Investigator Site
      • Cadiz, Espanha
        • Novartis Investigator Site
      • Granollers, Espanha
        • Novartis Investigator Site
      • Jaén, Espanha
        • Novartis Investigative Site
      • La Coruna, Espanha
        • Novartis Investigator Site
      • Leon, Espanha
        • Novartis Investigator Site
      • Madrid, Espanha
        • Novartis Investigator Site
      • Pamplona, Espanha
        • Novartis Investigator Site
      • Torrelavega, Espanha
        • Novartis Investigator Site
      • Valencia, Espanha
        • Novartis Investigator Site
      • Vigo, Espanha
        • 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
  • Peru
      • Antalya, Peru
        • Novartis Investigator Site
      • Canakkale, Peru
        • Novartis Investigator Site
      • Isparta, Peru
        • Novartis Investigator Site
      • Istanbul, Peru
        • Novartis Investigator Site
      • Kartal, Peru
        • Novartis Investigator Site
      • Kayseri, Peru
        • Novartis Investigator Site
      • Kozlu / Zonguldak, Peru
        • Novartis Investigator Site
      • Malatya, Peru
        • Novartis Investigator Site
      • Manisa, Peru
        • Novartis Investigator Site
      • Mecidiyekoy/Istanbul, Peru
        • Novartis Investigator Site
      • Yenisehir/Izmir, Peru
        • Novartis Investigator Site
  • África do Sul
      • Amanzimtoti, África do Sul
        • Novartis Investigator Site
      • Cape Town, África do Sul
        • Novartis Investigator Site
      • Johannesburg, África do Sul
        • Novartis Investigator Site
      • Midrand, África do Sul
        • Novartis Investigator Site
      • Umkomaas, África do Sul
        • Novartis Investigator Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Medicamento: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
Comparador Ativo: 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.
Medicamento: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
Medicamento: Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novartis Pharmaceuticals

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de março de 2009

Conclusão Primária (Real)

1 de março de 2010

Conclusão do estudo (Real)

1 de março de 2010

Datas de inscrição no estudo

Enviado pela primeira vez

15 de fevereiro de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de fevereiro de 2009

Primeira postagem (Estimativa)

18 de fevereiro de 2009

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

18 de agosto de 2011

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de julho de 2011

Última verificação

1 de julho de 2011

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CQAB149B2341

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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