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

22. juli 2011 opdateret af: 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)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1134

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Medicin: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
Aktiv komparator: 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.
Medicin: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
Medicin: Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2009

Primær færdiggørelse (Faktiske)

1. marts 2010

Studieafslutning (Faktiske)

1. marts 2010

Datoer for studieregistrering

Først indsendt

15. februar 2009

Først indsendt, der opfyldte QC-kriterier

15. februar 2009

Først opslået (Skøn)

18. februar 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. august 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juli 2011

Sidst verificeret

1. juli 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CQAB149B2341

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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