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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 november 2014 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

449

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: NVA237 + indacaterol
Läkemedel: NVA237 50 µg and indacaterol 150 µg
NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
Andra namn:
  • Glycopyrronium Bromide
Placebo-jämförare: Placebo to NVA237 + indacaterol
Läkemedel: Placebo to NVA237 and indacaterol 150 µg
Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Trough Forced Expiratory Volume at 1 Second (FEV1)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 12 weeks
All study emergent adverse events including Chronic Obstructive Pulmonary Disease exacerbations were monitored from screening through the end of study.
12 weeks

Samarbetspartners och utredare

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Sponsor

Novartis Pharmaceuticals

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2012

Primärt slutförande (Faktisk)

1 januari 2013

Avslutad studie (Faktisk)

1 januari 2013

Studieregistreringsdatum

Först inskickad

21 maj 2012

Först inskickad som uppfyllde QC-kriterierna

21 maj 2012

Första postat (Uppskatta)

23 maj 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

14 november 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 november 2014

Senast verifierad

1 november 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

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