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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 oppdatert av: 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)

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1134

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Legemiddel: 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.
Legemiddel: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
Legemiddel: Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2009

Primær fullføring (Faktiske)

1. mars 2010

Studiet fullført (Faktiske)

1. mars 2010

Datoer for studieregistrering

Først innsendt

15. februar 2009

Først innsendt som oppfylte QC-kriteriene

15. februar 2009

Først lagt ut (Anslag)

18. februar 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

18. august 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juli 2011

Sist bekreftet

1. juli 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CQAB149B2341

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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