Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

22. juli 2011 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1002

Fase

  • Fase 3

Kontakter og plasseringer

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

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 føderasjonen
      • Ekaterinburg, Den russiske føderasjonen
        • Novartis Investigator Site
      • Kazan, Den russiske føderasjonen
        • Novartis Investigator Site
      • Moscow, Den russiske føderasjonen
        • Novartis Investigator Site
      • Saint Petersburg, Den russiske føderasjonen
        • Novartis Investigator Site
      • Samara, Den russiske føderasjonen
        • Novartis Investigator Site
      • St Petersburg, Den russiske føderasjonen
        • Novartis Investigator Site
      • Yaroslavl, Den russiske føderasjonen
        • Novartis Investigator Site
      • Yekaterinburg, Den russiske føderasjonen
        • 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
  • Frankrike
      • Ambroise, Frankrike
        • Novartis Investigative Site
      • Beuvry, Frankrike
        • Novartis Investigative Site
      • Ferolles-Attilly, Frankrike
        • Novartis Investgative Site
      • Nice, Frankrike
        • Novartis Investigator Site
  • India
      • Chennai, India
        • Novartis Investigator Site
      • Coimbatore, India
        • Novartis Investigator Site
      • Goa, India
        • Novartis Investigator Site
      • Hyderabad, India
        • Novartis Investigator Site
      • Jaipur, India
        • Novartis Investigator Site
      • Kerala, India
        • Novartis Investigator Site
      • Mangalore, India
        • Novartis Investigator Site
      • Mumbai, India
        • Novartis Investigator Site
      • Vellore, India
        • Novartis Investigator Site
  • Island
      • Reykhavik, Island
        • Novartis Investigator Site
  • Italia
      • Ancona, Italia
        • Novartis Investigator Site
      • Arenzano, Italia
        • Novartis Investigator Site
      • Ascoli Piceno, Italia
        • Novartis Investigative Site
      • Brescia, Italia
        • Novartis Investigator Site
      • Cagliari, Italia
        • Novartis Investigator Site
      • Chieti, Italia
        • Novartis Investigator Site
      • Ferrara, Italia
        • Novartis Investigator Site
      • Milan, Italia
        • Novartis Investigator Site
      • Milano, Italia
        • Novartis Investigator Site
      • Orbassano, Italia
        • Novartis Investigator Site
      • Palermo, Italia
        • Novartis Investigator Site
      • Reggio Emilia, Italia
        • Novartis Investigator Site
      • Rome, Italia
        • Novartis Investigator Site
      • Sesto, Italia
        • Novartis Investigator Site
      • Siena, Italia
        • Novartis Investigator Site
      • Terni, Italia
        • 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
  • Slovakia
      • Bardejov, Slovakia
        • Novartis Investigator Site
      • Bratislava, Slovakia
        • Novartis Investigator Site
      • Kosice, Slovakia
        • Novartis Investigator Site
      • Kovice, Slovakia
        • Novartis Investigator Site
      • Spisska, Slovakia
        • 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
  • Tsjekkisk Republikk
      • Cvikov, Tsjekkisk Republikk
        • Novartis Investigator Site
      • Lovosice, Tsjekkisk Republikk
        • Novartis Investigator Site
      • Novy Jocin, Tsjekkisk Republikk
        • Novartis Investigator Site
      • Pardubice, Tsjekkisk Republikk
        • Novartis Investigator Site
      • Praha, Tsjekkisk Republikk
        • Novartis Investigator Site
      • Zatec, Tsjekkisk Republikk
        • 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

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:

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

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: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Indacaterol 150 μg
Indacaterol 150 μg once daily (o.d) inhaled
Legemiddel: 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.
Legemiddel: Placebo to Salmeterol
Placebo to salmeterol delivered via a proprietary dry powder inhaler
Legemiddel: 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.
Legemiddel: Placebo to Indacaterol
Placebo to Indacaterol inhaled via SDDPI.
Legemiddel: Salmeterol 50 μg
Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

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. november 2007

Primær fullføring (Faktiske)

1. januar 2009

Datoer for studieregistrering

Først innsendt

4. desember 2007

Først innsendt som oppfylte QC-kriteriene

4. desember 2007

Først lagt ut (Anslag)

5. desember 2007

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

  • CQAB149B2336

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. .

Abonnere