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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 novembre 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

449

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

40 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: NVA237 + indacaterol
Droga: NVA237 50 µg and indacaterol 150 µg
NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
Altri nomi:
  • Glycopyrronium Bromide
Comparatore placebo: Placebo to NVA237 + indacaterol
Droga: Placebo to NVA237 and indacaterol 150 µg
Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Trough Forced Expiratory Volume at 1 Second (FEV1)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 12 weeks
All study emergent adverse events including Chronic Obstructive Pulmonary Disease exacerbations were monitored from screening through the end of study.
12 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2012

Completamento primario (Effettivo)

1 gennaio 2013

Completamento dello studio (Effettivo)

1 gennaio 2013

Date di iscrizione allo studio

Primo inviato

21 maggio 2012

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2012

Primo Inserito (Stima)

23 maggio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

14 novembre 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 novembre 2014

Ultimo verificato

1 novembre 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

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