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

Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

22. juli 2011 opdateret af: Novartis

A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1002

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
      • Edmonton, Canada
        • Novartis Investigative Site
      • Edmonton, Canada
        • Novartis Investigator Site
      • London, Canada
        • Novartis Investigator Site
      • Mirabel, Canada
        • Novartis Investigator Site
      • Montreal, Canada
        • Novartis Investigator Site
      • Toronto, Canada
        • Novartis Investigator Site
  • Colombia
      • Barranquilla, Colombia
        • Novartis Investigator Site
      • Bogota D.C., Colombia
        • Novartis Investigator Site
      • Medellin, Colombia
        • Novartis Investigator Site
  • Danmark
      • Aalborg, Danmark
        • Novartis Investigator Site
      • Arhus, Danmark
        • Novartis Investigator Site
      • Copenhagen, Danmark
        • Novartis Investigative Site
      • Copenhagen, Danmark
        • Novartis Investigator Site
      • Frederikssund, Danmark
        • Novartis Investigator Site
      • Hellerup, Danmark
        • Novartis Investigator Site
      • Hvidovre, Danmark
        • Novartis Investigator Site
      • Odense, Danmark
        • Novartis Investigator Site
      • Roslev, Danmark
        • Novartis Investigator Site
      • Silkeborg, Danmark
        • Novartis Investigative Site
      • Soborg, Danmark
        • Novartis Investgative Site
      • Vaerloese, Danmark
        • Novartis Investigator Site
  • Den Russiske Føderation
      • Ekaterinburg, Den Russiske Føderation
        • Novartis Investigator Site
      • Kazan, Den Russiske Føderation
        • Novartis Investigator Site
      • Moscow, Den Russiske Føderation
        • Novartis Investigator Site
      • Saint Petersburg, Den Russiske Føderation
        • Novartis Investigator Site
      • Samara, Den Russiske Føderation
        • Novartis Investigator Site
      • St Petersburg, Den Russiske Føderation
        • Novartis Investigator Site
      • Yaroslavl, Den Russiske Føderation
        • Novartis Investigator Site
      • Yekaterinburg, Den Russiske Føderation
        • Novartis Investigator Site
  • Finland
      • Hus, Finland
        • Novartis Investigator Site
      • Jyvaskyla, Finland
        • Novartis Investigator Site
      • Lahti, Finland
        • Novartis Investigator Site
      • Oulu, Finland
        • Novartis Investigator Site
      • Tampere, Finland
        • Novartis Investigator Site
      • Turku, Finland
        • Novartis Investigator Site
  • Frankrig
      • Ambroise, Frankrig
        • Novartis Investigative Site
      • Beuvry, Frankrig
        • Novartis Investigative Site
      • Ferolles-Attilly, Frankrig
        • Novartis Investgative Site
      • Nice, Frankrig
        • Novartis Investigator Site
  • Indien
      • Chennai, Indien
        • Novartis Investigator Site
      • Coimbatore, Indien
        • Novartis Investigator Site
      • Goa, Indien
        • Novartis Investigator Site
      • Hyderabad, Indien
        • Novartis Investigator Site
      • Jaipur, Indien
        • Novartis Investigator Site
      • Kerala, Indien
        • Novartis Investigator Site
      • Mangalore, Indien
        • Novartis Investigator Site
      • Mumbai, Indien
        • Novartis Investigator Site
      • Vellore, Indien
        • Novartis Investigator Site
  • Island
      • Reykhavik, Island
        • Novartis Investigator Site
  • Italien
      • Ancona, Italien
        • Novartis Investigator Site
      • Arenzano, Italien
        • Novartis Investigator Site
      • Ascoli Piceno, Italien
        • Novartis Investigative Site
      • Brescia, Italien
        • Novartis Investigator Site
      • Cagliari, Italien
        • Novartis Investigator Site
      • Chieti, Italien
        • Novartis Investigator Site
      • Ferrara, Italien
        • Novartis Investigator Site
      • Milan, Italien
        • Novartis Investigator Site
      • Milano, Italien
        • Novartis Investigator Site
      • Orbassano, Italien
        • Novartis Investigator Site
      • Palermo, Italien
        • Novartis Investigator Site
      • Reggio Emilia, Italien
        • Novartis Investigator Site
      • Rome, Italien
        • Novartis Investigator Site
      • Sesto, Italien
        • Novartis Investigator Site
      • Siena, Italien
        • Novartis Investigator Site
      • Terni, Italien
        • Novartis Investigator Site
  • Peru
      • Callao, Peru
        • Novartis Investigator Site
      • Miraflores, Peru
        • Novartis Investigator Site
      • San Borja, Peru
        • Novartis Investigator Site
      • San Isidro, Peru
        • Novartis Investigator Site
      • San Martin de Porres, Peru
        • Novartis Investigator Site
      • Surco, Peru
        • Novartis Investigator Site
  • Slovakiet
      • Bardejov, Slovakiet
        • Novartis Investigator Site
      • Bratislava, Slovakiet
        • Novartis Investigator Site
      • Kosice, Slovakiet
        • Novartis Investigator Site
      • Kovice, Slovakiet
        • Novartis Investigator Site
      • Spisska, Slovakiet
        • Novartis Investigator Site
  • Taiwan
      • Changhua, Taiwan
        • Novartis Investigator Site
      • Kaohsiung, Taiwan
        • Novartis Investigator Site
      • Kaohusing, Taiwan
        • Novartis Investigator Site
      • Lin-ko, Taiwan
        • Novartis Investigator Site
      • Taichung, Taiwan
        • Novartis Investigator Site
      • Taipei, Taiwan
        • Novartis Investigator Site
  • Tjekkiet
      • Cvikov, Tjekkiet
        • Novartis Investigator Site
      • Lovosice, Tjekkiet
        • Novartis Investigator Site
      • Novy Jocin, Tjekkiet
        • Novartis Investigator Site
      • Pardubice, Tjekkiet
        • Novartis Investigator Site
      • Praha, Tjekkiet
        • Novartis Investigator Site
      • Zatec, Tjekkiet
        • Novartis Investigative Site
  • Tyskland
      • Bad Segeberg, Tyskland
        • Novartis Investigator Site
      • Berlin, Tyskland
        • Novartis Investigator Site
      • Bielefeld, Tyskland
        • Novartis Investigator Site
      • Bochum, Tyskland
        • Novartis Investigator Site
      • Bonn, Tyskland
        • Novartis Investigator Site
      • Bruehl, Tyskland
        • Novartis Investigator Site
      • Cottbus, Tyskland
        • Novartis Investigator Site
      • Dortmund, Tyskland
        • Novartis Investigator Site
      • Dueren, Tyskland
        • Novartis Investigator Site
      • Eggenfelden, Tyskland
        • Novartis Investigator Site
      • Eschwege, Tyskland
        • Novartis Investigator Site
      • Forchheim, Tyskland
        • Novartis Investigator Site
      • Freudenberg, Tyskland
        • Novartis Investigator Site
      • Furth, Tyskland
        • Novartis Investigator Site
      • Gelsenkirchen, Tyskland
        • Novartis Investigator Site
      • Gummersbach, Tyskland
        • Novartis Investigator Site
      • Hagen, Tyskland
        • Novartis Investigator Site
      • Hannover, Tyskland
        • Novartis Investigator Site
      • Kassel, Tyskland
        • Novartis Investigator Site
      • Kempten, Tyskland
        • Novartis Investigator Site
      • Koeln, Tyskland
        • Novartis Investigator Site
      • Landsberg am Lech, Tyskland
        • Novartis Investigator Site
      • Langenfeld, Tyskland
        • Novartis Investigator Site
      • Leipzig, Tyskland
        • Novartis Investigator Site
      • Mainz, Tyskland
        • Novartis Investigator Site
      • Muenchen, Tyskland
        • Novartis Investigator Site
      • Munich, Tyskland
        • Novartis Investigator Site
      • Neuss, Tyskland
        • Novartis Investigator Site
      • Nuremburg, Tyskland
        • Novartis Investigator Site
      • Oschersleben, Tyskland
        • Novartis Investigator Site
      • Ruhmannsfelden, Tyskland
        • Novartis Investigator Site
      • Sinsheim, Tyskland
        • Novartis Investigator Site
      • Solingen, Tyskland
        • Novartis Investigator Site
      • Steinfort-borghorst, Tyskland
        • Novartis Investigator Site
      • Vilshofen, Tyskland
        • Novartis Investigator Site
      • Wallerfing, Tyskland
        • Novartis Investigator Site
      • Witten, Tyskland
        • Novartis Investigator Site
  • Ungarn
      • Budapest, Ungarn
        • Novartis Investigator Site
      • Debrechen, Ungarn
        • Novartis Investigator Site
      • Deszk, Ungarn
        • Novartis Investigator Site
      • Mosonmagyarovar, Ungarn
        • Novartis Investigator Site
      • Szekesfehervar, Ungarn
        • 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:

Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:

  • Smoking history of at least 20 pack years
  • Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% predicted and >or= 30% of predicted normal value
  • Post-bronchodilator FEV1/FVC < 70%

("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)

Exclusion Criteria:

  • Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception
  • Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in
  • Patients requiring oxygen therapy for chronic hypoxemia (typically >15h/day)
  • Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period
  • Concomitant pulmonary disease
  • Asthma history (eosinophils > 400/mm3; symptoms prior to age 40). Includes history of childhood asthma
  • History of long QTc syndrome or QTc interval > 450 ms for males and >470 ms for females
  • Patients who have a clinically significant condition or a clinically relevant laboratory abnormality
  • History of reactions to sympathomimetic amines or inhaled medication
  • Inability to use the dry powder devices or perform spirometry
  • Irregular day/night, wake/sleep cycles, e.g. shift workers
  • Certain medications for COPD and allied conditions such as long acting bronchodilators must not be used prior to Visit 1 and for a pre-specified minimum washout period
  • Patients unable or unwilling to complete a patient diary

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Indacaterol 150 μg

Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Medicin: Indacaterol 150 μg
Indacaterol 150 μg once daily (o.d) inhaled
Medicin: Placebo to Salmeterol
Placebo to salmeterol delivered via a proprietary dry powder inhaler
Placebo komparator: Placebo

Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Medicin: Placebo to Salmeterol
Placebo to salmeterol delivered via a proprietary dry powder inhaler
Medicin: Placebo to Indacaterol
Placebo to Indacaterol inhaled via SDDPI.
Aktiv komparator: Salmeterol 50 μg

Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI).

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Medicin: Placebo to Indacaterol
Placebo to Indacaterol inhaled via SDDPI.
Medicin: Salmeterol 50 μg
Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment
Tidsramme: Week 12
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 salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.
Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment
Tidsramme: Week 12
SGRQ is a health related quality of life questionnaire consisting of 76 items in three sections: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health status. The mixed model used baseline SGRQ total score, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.
Week 12
Percentage of COPD "Days of Poor Control" During 26 Weeks of Treatment
Tidsramme: Up to 26 weeks
Participants rated their symptoms on a scale of 0=none to 3=severe. A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participants diary with a score >=2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). The mixed model used baseline percentage of "days of poor control", FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and one hour post inhalation of ipratropium as covariates.
Up to 26 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. november 2007

Primær færdiggørelse (Faktiske)

1. januar 2009

Datoer for studieregistrering

Først indsendt

4. december 2007

Først indsendt, der opfyldte QC-kriterier

4. december 2007

Først opslået (Skøn)

5. december 2007

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

  • CQAB149B2336

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 150 μg

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Azerbaijan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner