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Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (GLOW6)

12 listopada 2014 zaktualizowane przez: Novartis Pharmaceuticals

A 12-week Multi-center, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of the Co-administration of NVA237 + Indacaterol Once Daily vs. Indacaterol Once Daily in Patients With Moderate to Severe COPD

This study assessed the efficacy, safety and tolerability of the co-administration of NVA237 plus indacaterol taken once daily versus indacaterol taken once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

449

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Belgia
      • Brussel, Belgia, 1090
        • Novartis Investigative Site
      • Bruxelles, Belgia, 1070
        • Novartis Investigative Site
      • Genk, Belgia, 3600
        • Novartis Investigative Site
      • Gilly, Belgia, 6060
        • Novartis Investigative Site
      • Gosselies, Belgia, 6041
        • Novartis Investigative Site
      • Hasselt, Belgia, 3500
        • Novartis Investigative Site
      • Herentals, Belgia, 2200
        • Novartis Investigative Site
      • Jambes, Belgia, 5100
        • Novartis Investigative Site
      • Liège, Belgia, 4000
        • Novartis Investigative Site
      • Luxembourg, Belgia, 1210
        • Novartis Investigative Site
      • Malmedy/Bellevaux-Ligneuville, Belgia, 4960
        • Novartis Investigative Site
      • Montigny-le-tilleul, Belgia, 6110
        • Novartis Investigative Site
      • Turnhout, Belgia, 2300
        • Novartis Investigative Site
      • Yvoir, Belgia, 5530
        • Novartis Investigative Site
  • Bułgaria
      • Pleven, Bułgaria, 5800
        • Novartis Investigative Site
      • Plovdiv, Bułgaria, 4002
        • Novartis Investigative Site
      • Ruse, Bułgaria, 7002
        • Novartis Investigative Site
      • Sofia, Bułgaria, 1431
        • Novartis Investigative Site
      • Sofia, Bułgaria, 1606
        • Novartis Investigative Site
      • Sofia, Bułgaria, 1000
        • Novartis Investigative Site
      • Stara Zagora, Bułgaria, 6000
        • Novartis Investigative Site
      • Varna, Bułgaria, 9010
        • Novartis Investigative Site
  • Federacja Rosyjska
      • Moscow, Federacja Rosyjska, 125315
        • Novartis Investigative Site
      • N.Novgorod, Federacja Rosyjska, 603126
        • Novartis Investigative Site
      • Nizhny Novgorod, Federacja Rosyjska, 603018
        • Novartis Investigative Site
      • Saratov, Federacja Rosyjska, 410012
        • Novartis Investigative Site
  • Grecja
      • Athens, Grecja, 11527
        • Novartis Investigative Site
    • GR
      • Athens, GR, Grecja, 115 27
        • Novartis Investigative Site
      • Athens, GR, Grecja, 106 76
        • Novartis Investigative Site
      • Thessaloniki, GR, Grecja, 564 03
        • Novartis Investigative Site
  • Hiszpania
      • Barcelona, Hiszpania, 08025
        • Novartis Investigative Site
    • Andalucia
      • Malaga, Andalucia, Hiszpania, 29010
        • Novartis Investigative Site
    • Asturias
      • Gijon, Asturias, Hiszpania, 33290
        • Novartis Investigative Site
    • Cantabria
      • Torrelavega, Cantabria, Hiszpania, 39300
        • Novartis Investigative Site
    • Castilla la Mancha
      • Illescas, Castilla la Mancha, Hiszpania, 45200
        • Novartis Investigative Site
    • Castilla y Leon
      • Ponferrada, Castilla y Leon, Hiszpania, 24400
        • Novartis Investigative Site
    • Cataluña
      • Centelles, Cataluña, Hiszpania, 08540
        • Novartis Investigative Site
      • Salt, Cataluña, Hiszpania, 17190
        • Novartis Investigative Site
      • Sant Boi de Llobregat, Cataluña, Hiszpania, 08830
        • Novartis Investigative Site
      • Viladecans, Cataluña, Hiszpania
        • Novartis Investigative Site
    • Extremadura
      • Mérida, Extremadura, Hiszpania, 06800
        • Novartis Investigative Site
  • Indyk
      • Ankara, Indyk, 06490
        • Novartis Investigative Site
      • Istanbul, Indyk, 34854
        • Novartis Investigative Site
      • Istanbul, Indyk
        • Novartis Investigative Site
      • Kocaeli, Indyk, 41380
        • Novartis Investigative Site
      • Mersin, Indyk, 33079
        • Novartis Investigative Site
      • Yenisehir/Izmir, Indyk, 35110
        • Novartis Investigative Site
  • Irlandia
    • Cork
      • Wilton, Cork, Irlandia
        • Novartis Investigative Site
  • Słowacja
      • Bratislava, Słowacja, 826 06
        • Novartis Investigative Site
      • Kosice, Słowacja, 040 01
        • Novartis Investigative Site
      • Kralovsky Chlmec, Słowacja, 077 01
        • Novartis Investigative Site
    • Slovak Republic
      • Bardejov, Slovak Republic, Słowacja, 085 01
        • Novartis Investigative Site
      • Bojnice, Slovak Republic, Słowacja, 972 01
        • Novartis Investigative Site
      • Liptovsky Hradok, Slovak Republic, Słowacja, 033 01
        • Novartis Investigative Site
    • Slovensko
      • Námestovo, Slovensko, Słowacja, 02901
        • Novartis Investigative Site
  • Węgry
      • Budapest, Węgry, 1121
        • Novartis Investigative Site
      • Budapest, Węgry, 1046
        • Novartis Investigative Site
      • Deszk, Węgry, 6772
        • Novartis Investigative Site
      • Erd, Węgry, H-2030
        • Novartis Investigative Site
      • Godollo, Węgry, 2100
        • Novartis Investigative Site
  • Zjednoczone Królestwo
      • Bath, Zjednoczone Królestwo, BA1 2SR
        • Novartis Investigative Site
      • Bexhill-on-Sea, Zjednoczone Królestwo, TN40 1JJ
        • Novartis Investigative Site
      • Blackpool, Zjednoczone Królestwo, FY3 7EN
        • Novartis Investigative Site
      • Bradford, Zjednoczone Królestwo, BD9 6RJ
        • Novartis Investigative Site
      • Cambridge, Zjednoczone Królestwo, CB7 5JD
        • Novartis Investigative Site
      • Chesterfield, Zjednoczone Królestwo, S40 4AA
        • Novartis Investigative Site
      • Huntingdon, Zjednoczone Królestwo, PE29 6NT
        • Novartis Investigative Site
      • Manchester, Zjednoczone Królestwo, M20 2RN
        • Novartis Investigative Site
      • Newcastle-upon-Tyne, Zjednoczone Królestwo, NE7 7DN
        • Novartis Investigative Site
      • Newton Aycliffe, Zjednoczone Królestwo, DL5 4SE
        • Novartis Investigative Site
      • Reading, Zjednoczone Królestwo, RG7 3SQ
        • Novartis Investigative Site
      • Southbourne, Zjednoczone Królestwo
        • Novartis Investigative Site
      • Telford, Zjednoczone Królestwo, TF1 6TF
        • Novartis Investigative Site
      • Watford, Zjednoczone Królestwo, WD25 0EA
        • Novartis Investigative Site
      • Wiltshire, Zjednoczone Królestwo, SN15 2SB
        • Novartis Investigative Site
    • County Durham
      • Burnhope, County Durham, Zjednoczone Królestwo, DH7 0BD
        • Novartis Investigative Site
    • Suffolk
      • Alderton, Suffolk, Zjednoczone Królestwo, IP12 3DA
        • Novartis Investigative Site
    • Warwickshire
      • Atherstone, Warwickshire, Zjednoczone Królestwo, CV9 1EU
        • Novartis Investigative Site
      • Leamington Spa, Warwickshire, Zjednoczone Królestwo, CV32 4RA
        • Novartis Investigative Site
    • Yorkshire
      • Strensall, Yorkshire, Zjednoczone Królestwo, YO32 5UA
        • Novartis Investigative Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
  • Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 0.70 at screening.
  • Current or ex-smokers who have a smoking history of at least 10 pack years
  • Symptomatic patients according to daily diary data.

Exclusion Criteria:

  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential unless using adequate contraception.
  • Patients with Type I or uncontrolled Type II diabetes.
  • Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged
  • Patients with paroxysmal (e.g. intermittent) atrial fibrillation
  • Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)

Other protocol-defined inclusion/exclusion criteria may apply.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: NVA237 + indacaterol
Lek: NVA237 50 µg and indacaterol 150 µg
NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
Inne nazwy:
  • Glycopyrronium Bromide
Komparator placebo: Placebo to NVA237 + indacaterol
Lek: Placebo to NVA237 and indacaterol 150 µg
Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Trough Forced Expiratory Volume at 1 Second (FEV1)
Ramy czasowe: 12 weeks
Centralized spirometry according to internationally accepted standards was used. The model contained treatment, baseline smoking status and baseline inhaled corticosteroid (ICS) use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in region as a random effect. If trough FEV1 was missing at week 12, the latest non-missing pre-dose trough FEV1 (the mean of 45 and 15 min pre-dose measurements) from day 29, 57 or 84) was carried forward. These measurements had to have been taken before the next dose of study medication. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
12 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose
Ramy czasowe: 12 weeks
Centralized spirometry was used according to internationally accepted standards was used. The trapezoidal rule was applied to calculate FEV1 Area Under the Curve (AUC) and then normalized to the length of time. Whether the participants had complete or incomplete FEV1 assessments in respective time ranges, their AUCs were calculated based on the existing FEV1 measurements (i.e., the missing FEV1 measurements were not interpolated). Specifically, for those participants who had a FEV1 assessment at only one time-point, their AUC was approximated by the observed FEV1. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
12 weeks
Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks
Ramy czasowe: 12 weeks
Centralized spirometry was used according to internationally accepted standards was used. Peak FEV1 was defined as the maximum FEV1 during the first 4 hours post morning dosing. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in a region as a random effect. If all FEV1 measurements were missing from 30 minutes onward, the peak FEV1 was not calculated. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
12 weeks
FEV1 at Individual Time-points
Ramy czasowe: Day 1, Day 29, Day 57 and Days 84/85
Centralized spirometry according to internationally accepted standards was used. FEV1 was measured at all post-dose time points up to 4 hours, and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.
Day 1, Day 29, Day 57 and Days 84/85
Forced Vital Capacity (FVC) at Individual Time-points
Ramy czasowe: Day 1, Day 29, Day 57 and Days 84/85
FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FVC, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FVC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.
Day 1, Day 29, Day 57 and Days 84/85
Inspiratory Capacity (IC) at Individual Time-points
Ramy czasowe: Day 1, Days 84/85
Inspiratory Capacity (IC) was measured at 20 min pre-dose and at post-dose at 25 minutes, 1 hour 55 minutes, 3 hours 55 minutes and 23 hours 40 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of IC, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. IC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.
Day 1, Days 84/85
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication
Ramy czasowe: Baseline, 12 weeks
The number of puffs of rescue medication taken in the previous 12 hours was recorded in the patient diary in the morning and evening. The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening), then a half day was used in the denominator.
Baseline, 12 weeks
Transitional Dyspnea Index (TDI) Focal Score
Ramy czasowe: baseline, 12 weeks
Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during treatment using the Transitional Dyspnea Index (TDI). Analysis was done via mixed model. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of 1 is considered a minimal clinically important difference.
baseline, 12 weeks
Change From Baseline in Mean Daily Total and Individual Symptom Scores
Ramy czasowe: Baseline, 12 weeks
The symptoms (respiratory, cough, wheeze, sputum color, sputum production, breathlessness, sore throat, nasal discharge or congestion, and fever) for the whole active treatment period was analyzed using a mixed model, which contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline symptom score, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. Each symptom was scored as 0, 1, 2 or 3 where the description for each score varied. For each of the symptoms, the range of scores from 0 to 3 represented an increase in symptoms where 0 represented little to no symptom and 3 represented severe or worst symptom. The total symptom score, which is the sum of the individual scores, ranged from 0 (best possible outcome) to 27 (worst possible outcome).
Baseline, 12 weeks
Number of Participants With Adverse Events and Serious Adverse Events
Ramy czasowe: 12 weeks
All study emergent adverse events including Chronic Obstructive Pulmonary Disease exacerbations were monitored from screening through the end of study.
12 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Novartis Pharmaceuticals

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 maja 2012

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2013

Ukończenie studiów (Rzeczywisty)

1 stycznia 2013

Daty rejestracji na studia

Pierwszy przesłany

21 maja 2012

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 maja 2012

Pierwszy wysłany (Oszacować)

23 maja 2012

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

14 listopada 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 listopada 2014

Ostatnia weryfikacja

1 listopada 2014

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CNVA237A2316
  • 2011-005673-23 (Numer EudraCT)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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