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Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

3. december 2013 opdateret af: Novartis Pharmaceuticals

A 52-week Treatment, Multi-center, Randomized, Open Label, Parallel Group Study to Assess the Long Term Safety and Tolerability of QVA149 (110 Mcg Indacaterol / 50 Mcg Glycopyrrolate o.d.) Using Tiotropium (18 Mcg o.d.) as an Active Control in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

This is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237 ([glycopyrronium bromide]) using tiotropium as an active control in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

160

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Japan
      • Akita, Japan, 010-0933
        • Novartis Investigative Site
      • Fukuoka, Japan, 812-0033
        • Novartis Investigative Site
      • Fukuoka, Japan, 811-0213
        • Novartis Investigative Site
      • Fukuoka, Japan, 815-8588
        • Novartis Investigative Site
      • Kochi, Japan, 780-8077
        • Novartis Investigative Site
      • Osaka, Japan, 558-8558
        • Novartis Investigative Site
      • Wakayama, Japan, 641-8510
        • Novartis Investigative Site
    • Aichi
      • Anjo, Aichi, Japan, 446-8602
        • Novartis Investigative Site
      • Nagoya, Aichi, Japan, 457-8511
        • Novartis Investigative Site
      • Nishio-city, Aichi, Japan, 445-8510
        • Novartis Investigative Site
    • Fukuoka
      • Kasuga-city, Fukuoka, Japan, 816-0813
        • Novartis Investigative Site
      • Kitakyushu, Fukuoka, Japan, 820-0052
        • Novartis Investigative Site
      • Kurume, Fukuoka, Japan, 830-0011
        • Novartis Investigative Site
      • Yanagawa, Fukuoka, Japan, 832-0059
        • Novartis Investigative Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 070-8644
        • Novartis Investigative Site
      • Obihiro, Hokkaido, Japan, 080-0805
        • Novartis Investigative Site
      • Sapporo-city, Hokkaido, Japan, 060-8648
        • Novartis Investigative Site
    • Hyogo
      • Himeji-city, Hyogo, Japan, 672-8064
        • Novartis Investigative Site
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8610
        • Novartis Investigative Site
    • Kagawa
      • Takamatsu, Kagawa, Japan, 760-8538
        • Novartis Investigative Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 210-0852
        • Novartis Investigative Site
      • Yokohama, Kanagawa, Japan, 236-0051
        • Novartis Investigative Site
    • Kumamoto
      • Koshi-city, Kumamoto, Japan, 861-1196
        • Novartis Investigative Site
    • Mie
      • Matsusaka-city, Mie, Japan, 515-8544
        • Novartis Investigative Site
    • Nagano
      • Ueda, Nagano, Japan, 386-8610
        • Novartis Investigative Site
    • Osaka
      • Osaka-city, Osaka, Japan, 545-8586
        • Novartis Investigative Site
      • Osakasayama, Osaka, Japan, 589-0022
        • Novartis Investigative Site
      • Takatsuki, Osaka, Japan, 569-1192
        • Novartis Investigative Site
      • Toyonaka, Osaka, Japan, 560-8552
        • Novartis Investigative Site
    • Saitama
      • Kawaguhi-city, Saitama, Japan, 333-0833
        • Novartis Investigative Site
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 430-8525
        • Novartis Investigative Site
    • Tokyo
      • Fuchu, Tokyo, Japan, 183-8524
        • Novartis Investigative Site
      • Meguro, Tokyo, Japan, 152-8902
        • Novartis Investigative Site
    • Yamagata
      • Yamagata city, Yamagata, Japan, 990-8533
        • Novartis Investigative Site
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-0241
        • 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:

  • Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
  • Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
  • Patients with post-bronchodilator forced expiratory volume in one second (FEV1) ≥30% and < 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) < 0.7 at Visit 2.

Exclusion Criteria:

  • Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception
  • Patients requiring long term oxygen therapy
  • Patients who have had a lower respiratory tract infection within 4 weeks prior to Visit 1
  • Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Any patient with history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years
  • Patients with a history of certain cardiovascular comorbid conditions
  • Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
  • Patients in the active phase of a supervised pulmonary rehabilitation program
  • Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, sympathomimetic amines

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: QVA149
QVA149 110/50 μg once a day (o.d)
Medicin: QVA149
QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1
Aktiv komparator: Tiotropium
tiotropium 18 μg o.d.
Medicin: Tiotropium
Tiotropium (18 μg o.d.), delivered via Handihaler®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death
Tidsramme: 52 weeks
An AE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that was given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug were classified as a treatment emergent adverse event.
52 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antal patienter med nyligt opståede eller forværrede klinisk bemærkelsesværdige hæmatologiske værdier på ethvert tidspunkt over hele behandlingsperioden
Tidsramme: 52 uger
Klinisk bemærkelsesværdige hæmatologiske værdier var: hæmoglobin - mænd <11,5 g/dL, kvinder <9,5 g/dL; hæmatokrit - mænd <37%, kvinder <32%; antal hvide blodlegemer - <2800µL eller >16000µL; blodplader - <7,5 10*4/µL eller >70,0 10*4/µL
52 uger
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period
Tidsramme: 52 weeks
Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL
52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period
Tidsramme: 52 weeks
Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg.
52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period
Tidsramme: 52 weeks
Clinically notable change from baseline was an increase from baseline of 30 or greater milliseconds (ms).
52 weeks
Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline
Tidsramme: Weeks 3, 6, 12, 24, 36, 52
Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FEV1 value on Day 1 (Week 1).
Weeks 3, 6, 12, 24, 36, 52
Change in Pre-dose Forced Vital Capacity (FVC) From Baseline
Tidsramme: Weeks 3, 6, 12, 24, 36, 52
Pre-dose FVC is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FVC value on Day 1 (Week 1).
Weeks 3, 6, 12, 24, 36, 52

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

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 2011

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. september 2012

Datoer for studieregistrering

Først indsendt

25. januar 2011

Først indsendt, der opfyldte QC-kriterier

26. januar 2011

Først opslået (Skøn)

28. januar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. december 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2013

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CQVA149A1301

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 QVA149

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in New Zealand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner