Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks

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 Once Daily Indacaterol in Patients With Chronic Obstructive Pulmonary Disease

This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

318

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Anniston, Alabama, Forenede Stater, 36207-5710
        • Novartis Investigative Site
      • Jasper, Alabama, Forenede Stater, 35501
        • Novartis Investigative Site
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85306
        • Novartis Investigator Site
      • Phoenix, Arizona, Forenede Stater, 85006
        • Novartis Investigator Site
    • California
      • Fullerton, California, Forenede Stater, 92835
        • Novartis Investigator Site
      • Los Angeles, California, Forenede Stater, 90048
        • Novartis Investigator Site
      • Los Angeles, California, Forenede Stater, 90095
        • Novartis Investigator Site
      • Riverside, California, Forenede Stater, 92506
        • Novartis Investigator Site
    • Florida
      • Clearwater, Florida, Forenede Stater, 33756
        • Novartis Investigative Site
      • Clearwater, Florida, Forenede Stater, 33765
        • Novartis Investigative Site
      • Hollywood, Florida, Forenede Stater, 33021
        • Novartis Investigative Site
      • Miami, Florida, Forenede Stater, 33145
        • Novartis Investigative Site
      • Tampa, Florida, Forenede Stater, 33603
        • Novartis Investigative Site
      • Winter Park, Florida, Forenede Stater, 32789
        • Novartis Investigative Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30342
        • Novartis Investigative Site
    • Illinois
      • Normal, Illinois, Forenede Stater, 61761
        • Novartis Investigator Site
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • Novartis Investigator Site
    • Kentucky
      • Madisonville, Kentucky, Forenede Stater, 42431
        • Novartis Investigative Site
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808
        • Novartis Investigator Site
      • Opelousas, Louisiana, Forenede Stater, 70570
        • Novartis Investigator Site
    • Missouri
      • St. Charles, Missouri, Forenede Stater, 63301
        • Novartis Investigator Site
      • St. Louis, Missouri, Forenede Stater, 63141
        • Novartis Investigator Site
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Novartis Investigator Site
      • Omaha, Nebraska, Forenede Stater, 68114
        • Novartis Investigator Site
      • Omaha, Nebraska, Forenede Stater, 68134
        • Novartis Investigator Site
    • Nevada
      • Henderson, Nevada, Forenede Stater, 89014
        • Novartis Investigator Site
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Novartis Investigator Site
    • New Jersey
      • Cherry Hill, New Jersey, Forenede Stater, 08003
        • Novartis Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87108
        • Novartis Investigator Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28207
        • Novartis Investigative Site
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Novartis Investigative Site
      • Shelby, North Carolina, Forenede Stater, 28152
        • Novartis Investigative Site
    • Ohio
      • Canton, Ohio, Forenede Stater, 44718
        • Novartis Investigative Site
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Novartis Investigator Site
      • Columbus, Ohio, Forenede Stater, 43215
        • Novartis Investigative Site
      • Columbus, Ohio, Forenede Stater, 43213
        • Novartis Investigative Site
      • Marion, Ohio, Forenede Stater, 43302
        • Novartis Investigator Site
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97404
        • Novartis Investigator Site
      • Medford, Oregon, Forenede Stater, 97504
        • Novartis Investigator Site
    • Rhode Island
      • Cumberland, Rhode Island, Forenede Stater, 02864
        • Novartis Investigative Site
      • Pawtucket, Rhode Island, Forenede Stater, 02860
        • Novartis Investigative Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29407
        • Novartis Investigative Site
      • Charleston, South Carolina, Forenede Stater, 29412
        • Novartis Investigative Site
      • Easley, South Carolina, Forenede Stater, 29640
        • Novartis Investigative Site
      • Greenville, South Carolina, Forenede Stater, 29615
        • Novartis Investigative Site
      • North Charleston, South Carolina, Forenede Stater, 29406
        • Novartis Investigative Site
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Novartis Investigative Site
      • Union, South Carolina, Forenede Stater, 29379
        • Novartis Investigative Site
    • Texas
      • Arlington, Texas, Forenede Stater, 76012
        • Novartis Investigator Site
      • Dickinson, Texas, Forenede Stater, 77539
        • Novartis Investigator Site
      • El Paso, Texas, Forenede Stater, 79903
        • Novartis Investigator Site
      • McKinney, Texas, Forenede Stater, 75069
        • Novartis Investigator Site
    • Vermont
      • South Burlington, Vermont, Forenede Stater, 05403
        • Novartis Investigative Site
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23229
        • Novartis Investigative 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 COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

    1. Smoking history of at least 10 pack-years
    2. Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
    3. Post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

  • Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for in the 6 weeks prior to screening
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening
  • 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 may apply

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 75 µg

Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Medicin: Indacaterol
Once daily via single-dose dry powder inhaler (SDDPI)
Placebo komparator: Placebo

Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Medicin: Placebo to indacaterol
Once daily via SDDPI

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment
Tidsramme: after 12 weeks
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.
after 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Transition Dyspnoea Index (TDI) Focal Score After 12 Weeks of Treatment
Tidsramme: after 12 weeks
TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 50-70 minutes post inhalation of ipratropium as covariates.
after 12 weeks

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. januar 2010

Primær færdiggørelse (Faktiske)

1. juni 2010

Datoer for studieregistrering

Først indsendt

12. februar 2010

Først indsendt, der opfyldte QC-kriterier

12. februar 2010

Først opslået (Skøn)

15. februar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. 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

  • CQAB149B2355

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 Indacaterol

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lebanon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner