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

22 luglio 2011 aggiornato da: 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)

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1134

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

40 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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®).
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2009

Completamento primario (Effettivo)

1 marzo 2010

Completamento dello studio (Effettivo)

1 marzo 2010

Date di iscrizione allo studio

Primo inviato

15 febbraio 2009

Primo inviato che soddisfa i criteri di controllo qualità

15 febbraio 2009

Primo Inserito (Stima)

18 febbraio 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 agosto 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 luglio 2011

Ultimo verificato

1 luglio 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CQAB149B2341

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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