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

22. juli 2011 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

416

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

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

• 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

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
Placebo komparator: Placebo til indacaterol
Patienter inhalerede placebo til indacaterol én gang dagligt om morgenen mellem 8:00 og 11:00 via en enkeltdosis tørpulverinhalator (SDDPI) i 12 uger. Daglig inhaleret kortikosteroidbehandling (hvis relevant) skulle forblive stabil gennem hele undersøgelsen. Den korttidsvirkende β2-agonist salbutamol/albuterol var tilgængelig til redningsbrug under hele undersøgelsen.
Medicin: Placebo til indacaterol
Placebo til indacaterol blev leveret i pulverfyldte kapsler sammen med en enkeltdosis tørpulverinhalator (SDDPI).
Eksperimentel: 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.
Medicin: Indacaterol 150 μg
Indacaterol blev leveret i pulverfyldte kapsler sammen med en enkeltdosis tørpulverinhalator (SDDPI).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis

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. februar 2008

Primær færdiggørelse (Faktiske)

1. juli 2008

Studieafslutning (Faktiske)

1. juli 2008

Datoer for studieregistrering

Først indsendt

15. februar 2008

Først indsendt, der opfyldte QC-kriterier

15. februar 2008

Først opslået (Skøn)

27. februar 2008

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

  • CQAB149B2346
  • EUDRACT Number: 2008-000301-11

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 .

Kliniske forsøg med Placebo til indacaterol

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Armenia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner