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Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

28. juni 2018 opdateret af: Novartis Pharmaceuticals

A Randomized, Double-blind, Placebo Controlled, Multicentre Study to Determine the Effect of QVA149 on Lung Function in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

154

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Antwerpen, Belgien
        • Novartis Investigator Site
      • Gent, Belgien
        • Novartis Investigator Site
      • Jambes, Belgien
        • Novartis Investigator Site
      • Saint Vith, Belgien
        • Novartis Investigator Site
  • Canada
      • Moncton, Canada
        • Novartis Investigator Site
      • Montreal, Canada
        • Novartis Investigator Site
      • Toronto, Canada
        • Novartis Investigator Site
  • Forenede Stater
    • Missouri
      • Saint Louis, Missouri, Forenede Stater
        • Novartis Investigator Site
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater
        • Novartis Investigator Site
      • Raleigh, North Carolina, Forenede Stater
        • Novartis Investigator Site
  • Holland
      • Almelo, Holland
        • Novartis Investigator Site
      • Breda, Holland
        • Novartis Investigator Site
      • Eindhoven, Holland
        • Novartis Investigator Site
      • Heerlen, Holland
        • Novartis Investigator Site
      • Nijmegen, Holland
        • Novartis Investigator Site
      • Veldhoven, Holland
        • Novartis Investigator Site
  • Tyskland
      • Bad Worishofen, Tyskland
        • Novartis Investigator Site
      • Berlin, Tyskland
        • Novartis Investigator Site
      • Frankfurt, Tyskland
        • Novartis Investigator Site
      • Mainz, Tyskland
        • Novartis Investigator Site
      • Rudersdorf, Tyskland
        • Novartis Investigator Site
      • Wiesbaden, Tyskland
        • 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:

  1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
  2. Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
  3. Patients who have smoking history of at least 10 pack years.
  4. Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.70.

Exclusion Criteria:

  1. Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
  2. Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
  3. Patients who have had a respiratory tract infection within 6 weeks prior to screening.
  4. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
  5. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3.
  6. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
  7. Patients with uncontrolled Type I and Type II diabetes.
  8. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
  9. Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
  10. Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (>450 ms for males or >470 ms for females).
  11. Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.

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: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: indacaterol/glycopyrrolate 300/50 μg
One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
Medicin: indacaterol/glycopyrrolate
Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.
Andre navne:
  • QVA149
Aktiv komparator: indacaterol 600 μg
Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Medicin: indacaterol
Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Andre navne:
  • QAB149
Aktiv komparator: indacaterol 300 μg
One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
Medicin: indacaterol
Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Andre navne:
  • QAB149
Placebo komparator: placebo
Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
Medicin: placebo
Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7
Tidsramme: Baseline, Day 7
Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the average of the 23 hour 15 minute and 23 hour 45 minute measurements post dosing. Baseline FEV1 is the mean of the 45 minute and 15 minute pre-dose FEV1 values at day 1 of each period. Least square means are based on the Analysis of Covariance Trough FEV1 at day 7 = sequence effect + patient(sequence) + period effect + treatment effect + (period) baseline FEV1 + error.
Baseline, Day 7

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7
Tidsramme: Day 7
Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.
Day 7
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events
Tidsramme: 47 days
Additional information about adverse events can be found in the Adverse Event Section.
47 days

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. december 2007

Primær færdiggørelse (Faktiske)

1. september 2008

Studieafslutning (Faktiske)

1. september 2008

Datoer for studieregistrering

Først indsendt

10. december 2007

Først indsendt, der opfyldte QC-kriterier

10. december 2007

Først opslået (Skøn)

11. december 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CQVA149A2204

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Kliniske forsøg med indacaterol/glycopyrrolate

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