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Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

16. februar 2016 opdateret af: Novartis Pharmaceuticals

Multicenter, Randomized, Blinded, Placebo-controlled, Crossover, Single-dose Study to Assess the Effect of Indacaterol (150 μg) Versus Tiotropium (18 μg) on Inspiratory Capacity in Moderate Chronic Obstructive Pulmonary Disease (COPD) Patients

This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

54

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Italien
      • Bergamo, Italien
        • Novartis Investigative Site
      • Brescia, Italien
        • Novartis Investigative Site
      • Cava De' Tirreni, Italien
        • Novartis Investigative Site
      • Genova, Italien
        • Novartis Investigative Site
      • Milano, Italien
        • Novartis Investigative Site
      • Orbassano, Italien
        • Novartis Investigative Site
      • Pavia, Italien
        • Novartis Investigative Site
      • Reggio Emilia, Italien
        • Novartis Investigative Site
      • Sesto San Giovanni, Italien
        • Novartis Investigative Site
      • Treviso, Italien
        • Novartis Investigative Site
      • Verona, Italien
        • 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 moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:

    1. Smoking history of at least 10 pack-years.
    2. Forced expiratory volume in 1 second (FEV1) < 80% and ≥ 50% of the predicted normal value.
    3. Post-bronchodilator FEV1/Force vital capacity (FVC) < 0.7.

Exclusion Criteria:

  • Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization 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 alpha-1-antitrypsin deficiency.
  • Patients with contraindications for tiotropium treatment.
  • Patients with a history of hypersensitivity to any of the study drugs or to drugs from similar drug classes.

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: Crossover opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Indacaterol 150 μg-tiotropium 18 μg-placebo
Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Medicin: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Medicin: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Medicin: Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Eksperimentel: Tiotropium 18 μg-placebo-indacaterol 150 μg
Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Medicin: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Medicin: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Medicin: Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Eksperimentel: Placebo-indacaterol 150 μg-tiotropium 18 μg
Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Medicin: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Medicin: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Medicin: Placebo
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment
Tidsramme: 4 hour period following inhalation of study treatment
During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.
4 hour period following inhalation of study treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
Tidsramme: 4 hour period following inhalation of study treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
4 hour period following inhalation of study treatment
Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
Tidsramme: 4 hour period following inhalation of study treatment
FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
4 hour period following inhalation of study treatment

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

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. oktober 2009

Primær færdiggørelse (Faktiske)

1. marts 2010

Studieafslutning (Faktiske)

1. marts 2010

Datoer for studieregistrering

Først indsendt

21. oktober 2009

Først indsendt, der opfyldte QC-kriterier

21. oktober 2009

Først opslået (Skøn)

22. oktober 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. februar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. februar 2016

Sidst verificeret

1. februar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CQAB149BIT01
  • 2009-013763-19 (EudraCT nummer)

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

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