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

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

3. desember 2013 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

160

Fase

  • Fase 3

Kontakter og plasseringer

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

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

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:

  • 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

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: QVA149
QVA149 110/50 μg once a day (o.d)
Legemiddel: QVA149
QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1
Aktiv komparator: Tiotropium
tiotropium 18 μg o.d.
Legemiddel: Tiotropium
Tiotropium (18 μg o.d.), delivered via Handihaler®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
Antall pasienter med nylig oppstått eller forverrede klinisk bemerkelsesverdige hematologiske verdier til enhver tid over hele behandlingsperioden
Tidsramme: 52 uker
Klinisk bemerkelsesverdige hematologiske verdier var: hemoglobin - hann <11,5 g/dL, kvinne <9,5 g/dL; hematokrit - hann <37%, kvinne <32%; antall hvite blodlegemer - <2800µL eller >16000µL; blodplater - <7,5 10*4/µL eller >70,0 10*4/µL
52 uker
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novartis Pharmaceuticals

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. januar 2011

Primær fullføring (Faktiske)

1. september 2012

Studiet fullført (Faktiske)

1. september 2012

Datoer for studieregistrering

Først innsendt

25. januar 2011

Først innsendt som oppfylte QC-kriteriene

26. januar 2011

Først lagt ut (Anslag)

28. januar 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

27. desember 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. desember 2013

Sist bekreftet

1. desember 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CQVA149A1301

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