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Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

22. juli 2011 oppdatert av: Novartis

A 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease

This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

416

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Belgia
      • Lanaken, Belgia
        • Novartis Investigative Site
  • Forente stater
    • Alabama
      • Anniston, Alabama, Forente stater, 36207-5710
        • Novartis Investigative Site
      • Birmingham, Alabama, Forente stater, 35209-6870
        • Novartis Investigative Site
      • Jasper, Alabama, Forente stater, 35501
        • Novartis Investigative Site
      • Mobile, Alabama, Forente stater, 36608-6705
        • Novartis Investigative Site
    • Arizona
      • Glendale, Arizona, Forente stater, 85306
        • Novartis Investigator Site
      • Phoenix, Arizona, Forente stater, 85006-2611
        • Novartis Investigative Site
      • Phoenix, Arizona, Forente stater, 85013-4232
        • 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 Investigative Site
    • California
      • Buena Park, California, Forente stater, 90620
        • Novartis Investigative Site
      • Encinitas, California, Forente stater, 92024-1332
        • Novartis Investigative Site
      • Fresno, California, Forente stater, 93710
        • Novartis Investigative Site
      • Fullerton, California, Forente stater, 92835
        • Novartis Investigative Site
      • Los Angeles, California, Forente stater, 90048
        • Novartis Investigative Site
      • Orange, California, Forente stater, 92869
        • Novartis Investigative Site
      • Palmdale, California, Forente stater, 93551-1411
        • Novartis Investigative Site
      • Riverside, California, Forente stater, 92506
        • Novartis Investigative Site
      • San Jose, California, Forente stater, 95117
        • Novartis Investigative Site
      • San Mateo, California, Forente stater, 94401
        • Novartis Investigative Site
      • Stockton, California, Forente stater, 95207
        • Novartis Investigative Site
      • Torrance, California, Forente stater, 90503
        • Novartis Investigative Site
      • Vista, California, Forente stater, 92083
        • Novartis Investigative Site
      • Walnut Creek, California, Forente stater, 94598
        • Novartis Investigative Site
    • Colorado
      • Fort Collins, Colorado, Forente stater, 80528-3400
        • Novartis Investigative Site
      • Golden, Colorado, Forente stater, 80401
        • Novartis Investigative Site
      • Wheat Ridge, Colorado, Forente stater, 80033-4300
        • Novartis Investigator Site
    • Delaware
      • Newark, Delaware, Forente stater, 19713
        • Novartis Investigative Site
    • Florida
      • Clearwater, Florida, Forente stater, 33765
        • Novartis Investigative Site
      • Largo, Florida, Forente stater, 33770-2335
        • Novartis Investigative Site
      • Ocala, Florida, Forente stater, 34471
        • Novartis Investigative Site
      • Pensacola, Florida, Forente stater, 32503
        • Novartis Investigative Site
      • Pensacola, Florida, Forente stater, 32504
        • Novartis Investigative Site
      • Pensacola, Florida, Forente stater, 32504-8756
        • Novartis Investigative Site
      • Rockledge, Florida, Forente stater, 32955
        • Novartis Investigative Site
      • Sarasota, Florida, Forente stater, 34233-1272
        • Novartis Investigator Site
      • South Miami, Florida, Forente stater, 33143
        • Novartis Investigative Site
      • Tamarac, Florida, Forente stater, 33321
        • Novartis Investigative Site
      • Tampa, Florida, Forente stater, 33603
        • Novartis Investigative Site
      • Zephyrhills, Florida, Forente stater, 33542-7505
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, Forente stater, 30342
        • Novartis Investigative Site
      • Austell, Georgia, Forente stater, 30106-1110
        • Novartis Investigative Site
    • Illinois
      • Normal, Illinois, Forente stater, 61761
        • Novartis Investigative Site
      • O fallon, Illinois, Forente stater, 62269
        • Novartis Investigative Site
      • River Forest, Illinois, Forente stater, 60305
        • Novartis Investigative Site
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46285
        • Novartis Investigative Site
    • Iowa
      • Ames, Iowa, Forente stater, 50010
        • Novartis Investigative Site
      • Iowa City, Iowa, Forente stater, 52240
        • Novartis Investigative Site
    • Kansas
      • Shawnee, Kansas, Forente stater, 66216-1800
        • Novartis Investigative Site
    • Kentucky
      • Crescent springs, Kentucky, Forente stater, 41017
        • Novartis Investigative Site
      • Lexington, Kentucky, Forente stater, 40504
        • Novartis Investigative Site
      • Madisonville, Kentucky, Forente stater, 42431
        • Novartis Investigative Site
    • Louisiana
      • Metairie, Louisiana, Forente stater, 70006-4225
        • Novartis Investigative Site
      • Opelousas, Louisiana, Forente stater, 70570
        • Novartis Investigative Site
      • Slidell, Louisiana, Forente stater, 70458
        • Novartis Investigative Site
    • Massachusetts
      • Worcester, Massachusetts, Forente stater, 01605
        • Novartis Investigative Site
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48105-9755
        • Novartis Investigative Site
      • Clarkston, Michigan, Forente stater, 48346
        • Novartis Investigative Site
      • Flint, Michigan, Forente stater, 58532
        • Novartis Investigative Site
      • Livonia, Michigan, Forente stater, 48152
        • Novartis Investigative Site
      • Troy, Michigan, Forente stater, 48085
        • Novartis Investigative Site
    • Minnesota
      • Edina, Minnesota, Forente stater, 55435
        • Novartis Investigator Site
      • Minneapolis, Minnesota, Forente stater, 55407
        • Novartis Investigative Site
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63141
        • Novartis Investigator Site
      • St Charles, Missouri, Forente stater, 63301-2847
        • Novartis Investigative Site
    • Montana
      • Kalispell, Montana, Forente stater, 59901
        • Novartis Investigative Site
      • Missoula, Montana, Forente stater, 59808
        • Novartis Investigative Site
    • Nebraska
      • Lincoln, Nebraska, Forente stater, 68510
        • Novartis Investigative Site
      • Omaha, Nebraska, Forente stater, 68134
        • Novartis Investigative Site
      • Omaha, Nebraska, Forente stater, 68114-3570
        • Novartis Investigative Site
    • Nevada
      • Henderson, Nevada, Forente stater, 89014
        • Novartis Investigative Site
      • Las Vegas, Nevada, Forente stater, 89102-4508
        • Novartis Investigative Site
    • New Jersey
      • Cherry Hill, New Jersey, Forente stater, 08003
        • Novartis Investigative Site
      • Summit, New Jersey, Forente stater, 07901
        • Novartis Investigative Site
    • New York
      • Cortland, New York, Forente stater, 13045
        • Novartis Investigative Site
      • Rochester, New York, Forente stater, 14618
        • Novartis Investigative Site
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28207
        • Novartis Investigative Site
      • Charlotte, North Carolina, Forente stater, 28277
        • Novartis Investigative Site
      • High Point, North Carolina, Forente stater, 27262-4320
        • Novartis Investigative Site
      • Shelby, North Carolina, Forente stater, 28150
        • Novartis Investigative Site
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45231
        • Novartis Investigative Site
      • Cincinnati, Ohio, Forente stater, 45242
        • Novartis Investigator Site
      • Cincinnati, Ohio, Forente stater, 45227
        • Novartis Investigative Site
      • Columbus, Ohio, Forente stater, 43215
        • Novartis Investigative Site
      • Columbus, Ohio, Forente stater, 43213
        • Novartis Investigative Site
      • Marion, Ohio, Forente stater, 43302
        • Novartis Investigative Site
      • Thornville, Ohio, Forente stater, 43076-8010
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73112
        • Novartis Investigative Site
      • Tulsa, Oklahoma, Forente stater, 74135-2920
        • Novartis Investigative Site
    • Oregon
      • Eugene, Oregon, Forente stater, 97404
        • Novartis Investigative Site
      • Medford, Oregon, Forente stater, 97504-9741
        • Novartis Investigative Site
      • Portland, Oregon, Forente stater, 97213
        • Novartis Investigative Site
    • Pennsylvania
      • Erie, Pennsylvania, Forente stater, 15608
        • Novartis Investigative Site
      • Homestead, Pennsylvania, Forente stater, 15120
        • Novartis Investigative Site
      • Pittsburgh, Pennsylvania, Forente stater, 15243-1800
        • Novartis Investigative Site
    • Rhode Island
      • Cumberland, Rhode Island, Forente stater, 02864
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29412
        • Novartis Investigative Site
      • Gaffney, South Carolina, Forente stater, 29340
        • Novartis Investigative Site
      • Greenville, South Carolina, Forente stater, 29615
        • Novartis Investigative Site
      • N. Charleston, South Carolina, Forente stater, 29406-9167
        • Novartis Investigative Site
      • Spartanburg, South Carolina, Forente stater, 29303
        • Novartis Investigative Site
      • Union, South Carolina, Forente stater, 29379
        • Novartis Investigative Site
    • Tennessee
      • Johnson City, Tennessee, Forente stater, 37601
        • Novartis Investigative Site
    • Texas
      • Amarillo, Texas, Forente stater, 79106
        • Novartis Investigative Site
      • El Paso, Texas, Forente stater, 79902-5107
        • Novartis Investigative Site
      • Ft. Worth, Texas, Forente stater, 76104-4185
        • Novartis Investigative Site
      • New braunfels, Texas, Forente stater, 78130-6113
        • Novartis Investigative Site
      • San Antonio, Texas, Forente stater, 78229
        • Novartis Investigative Site
    • Utah
      • Payson, Utah, Forente stater, 84651
        • Novartis Investigative Site
    • Virginia
      • Abingdon, Virginia, Forente stater, 24210-2921
        • Novartis Investigative Site
      • Lynchburg, Virginia, Forente stater, 24501
        • Novartis Investigative Site
      • Richmond, Virginia, Forente stater, 23229
        • Novartis Investigative Site
      • Richmond, Virginia, Forente stater, 23298
        • Novartis Investigative Site
    • Washington
      • Spokane, Washington, Forente stater, 99201
        • Novartis Investigative Site
      • Spokane Valley, Washington, Forente stater, 99216-1092
        • Novartis Investigative Site
      • Tacoma, Washington, Forente stater, 98405
        • Novartis Investigative Site
    • West Virginia
      • Morgantown, West Virginia, Forente stater, 26505-2713
        • Novartis Investigative Site
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53209
        • Novartis Investigative Site
  • New Zealand
      • Tauranga, New Zealand
        • 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:

• Male or female patients aged 40 years or over with moderate to severe chronic obstructive pulmonary disease (COPD) plus

  • 20 pack-year smoking history
  • Signed informed consent
  • Post-bronchodilator forced expiratory volume in 1 second )FEV1) ≥ 30% and < 80% predicted FEV1/FVC (forced vital capacity) < 70%

Exclusion Criteria include:

  • History of asthma
  • Prior exposure to indacaterol
  • Active cancer or history of cancer
  • Patients with concomitant pulmonary disease
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged
  • Patients unable to successfully use a dry-powder inhaler device or perform spirometry measurements

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
Placebo komparator: Placebo mot indacaterol
Pasienter inhalerte placebo til indacaterol én gang daglig om morgenen mellom 8:00 og 11:00 via en enkeltdose tørrpulverinhalator (SDDPI) i 12 uker. Daglig inhalert kortikosteroidbehandling (hvis aktuelt) skulle forbli stabil gjennom hele studien. Den korttidsvirkende β2-agonisten salbutamol/albuterol var tilgjengelig for redningsbruk gjennom hele studien.
Legemiddel: Placebo til indacaterol
Placebo til indacaterol ble levert i pulverfylte kapsler sammen med en enkeltdose tørrpulverinhalator (SDDPI).
Eksperimentell: Indacaterol 150 μg
Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. 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 ble levert i pulverfylte kapsler sammen med en enkeltdose tørrpulverinhalator (SDDPI).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)
Tidsramme: 24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol 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 the study (Week 12 + 1 day, Day 85)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
24 hours post-dose on Day 2

Samarbeidspartnere og etterforskere

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

Sponsor

Novartis

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. februar 2008

Primær fullføring (Faktiske)

1. juli 2008

Studiet fullført (Faktiske)

1. juli 2008

Datoer for studieregistrering

Først innsendt

15. februar 2008

Først innsendt som oppfylte QC-kriteriene

15. februar 2008

Først lagt ut (Anslag)

27. februar 2008

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

  • CQAB149B2346
  • EUDRACT Number: 2008-000301-11

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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