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 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
449
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Brussel, Belgique, 1090
- Novartis Investigative Site
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Bruxelles, Belgique, 1070
- Novartis Investigative Site
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Genk, Belgique, 3600
- Novartis Investigative Site
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Gilly, Belgique, 6060
- Novartis Investigative Site
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Gosselies, Belgique, 6041
- Novartis Investigative Site
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Hasselt, Belgique, 3500
- Novartis Investigative Site
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Herentals, Belgique, 2200
- Novartis Investigative Site
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Jambes, Belgique, 5100
- Novartis Investigative Site
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Liège, Belgique, 4000
- Novartis Investigative Site
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Luxembourg, Belgique, 1210
- Novartis Investigative Site
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Malmedy/Bellevaux-Ligneuville, Belgique, 4960
- Novartis Investigative Site
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Montigny-le-tilleul, Belgique, 6110
- Novartis Investigative Site
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Turnhout, Belgique, 2300
- Novartis Investigative Site
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Yvoir, Belgique, 5530
- Novartis Investigative Site
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Pleven, Bulgarie, 5800
- Novartis Investigative Site
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Plovdiv, Bulgarie, 4002
- Novartis Investigative Site
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Ruse, Bulgarie, 7002
- Novartis Investigative Site
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Sofia, Bulgarie, 1431
- Novartis Investigative Site
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Sofia, Bulgarie, 1606
- Novartis Investigative Site
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Sofia, Bulgarie, 1000
- Novartis Investigative Site
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Stara Zagora, Bulgarie, 6000
- Novartis Investigative Site
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Varna, Bulgarie, 9010
- Novartis Investigative Site
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Barcelona, Espagne, 08025
- Novartis Investigative Site
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Andalucia
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Malaga, Andalucia, Espagne, 29010
- Novartis Investigative Site
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Asturias
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Gijon, Asturias, Espagne, 33290
- Novartis Investigative Site
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Cantabria
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Torrelavega, Cantabria, Espagne, 39300
- Novartis Investigative Site
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Castilla la Mancha
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Illescas, Castilla la Mancha, Espagne, 45200
- Novartis Investigative Site
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Castilla y Leon
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Ponferrada, Castilla y Leon, Espagne, 24400
- Novartis Investigative Site
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Cataluña
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Centelles, Cataluña, Espagne, 08540
- Novartis Investigative Site
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Salt, Cataluña, Espagne, 17190
- Novartis Investigative Site
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Sant Boi de Llobregat, Cataluña, Espagne, 08830
- Novartis Investigative Site
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Viladecans, Cataluña, Espagne
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Extremadura
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Mérida, Extremadura, Espagne, 06800
- Novartis Investigative Site
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Moscow, Fédération Russe, 125315
- Novartis Investigative Site
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N.Novgorod, Fédération Russe, 603126
- Novartis Investigative Site
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Nizhny Novgorod, Fédération Russe, 603018
- Novartis Investigative Site
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Saratov, Fédération Russe, 410012
- Novartis Investigative Site
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Athens, Grèce, 11527
- Novartis Investigative Site
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GR
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Athens, GR, Grèce, 115 27
- Novartis Investigative Site
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Athens, GR, Grèce, 106 76
- Novartis Investigative Site
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Thessaloniki, GR, Grèce, 564 03
- Novartis Investigative Site
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Budapest, Hongrie, 1121
- Novartis Investigative Site
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Budapest, Hongrie, 1046
- Novartis Investigative Site
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Deszk, Hongrie, 6772
- Novartis Investigative Site
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Erd, Hongrie, H-2030
- Novartis Investigative Site
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Godollo, Hongrie, 2100
- Novartis Investigative Site
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Cork
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Wilton, Cork, Irlande
- Novartis Investigative Site
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Bath, Royaume-Uni, BA1 2SR
- Novartis Investigative Site
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Bexhill-on-Sea, Royaume-Uni, TN40 1JJ
- Novartis Investigative Site
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Blackpool, Royaume-Uni, FY3 7EN
- Novartis Investigative Site
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Bradford, Royaume-Uni, BD9 6RJ
- Novartis Investigative Site
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Cambridge, Royaume-Uni, CB7 5JD
- Novartis Investigative Site
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Chesterfield, Royaume-Uni, S40 4AA
- Novartis Investigative Site
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Huntingdon, Royaume-Uni, PE29 6NT
- Novartis Investigative Site
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Manchester, Royaume-Uni, M20 2RN
- Novartis Investigative Site
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Newcastle-upon-Tyne, Royaume-Uni, NE7 7DN
- Novartis Investigative Site
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Newton Aycliffe, Royaume-Uni, DL5 4SE
- Novartis Investigative Site
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Reading, Royaume-Uni, RG7 3SQ
- Novartis Investigative Site
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Southbourne, Royaume-Uni
- Novartis Investigative Site
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Telford, Royaume-Uni, TF1 6TF
- Novartis Investigative Site
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Watford, Royaume-Uni, WD25 0EA
- Novartis Investigative Site
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Wiltshire, Royaume-Uni, SN15 2SB
- Novartis Investigative Site
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County Durham
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Burnhope, County Durham, Royaume-Uni, DH7 0BD
- Novartis Investigative Site
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Suffolk
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Alderton, Suffolk, Royaume-Uni, IP12 3DA
- Novartis Investigative Site
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Warwickshire
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Atherstone, Warwickshire, Royaume-Uni, CV9 1EU
- Novartis Investigative Site
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Leamington Spa, Warwickshire, Royaume-Uni, CV32 4RA
- Novartis Investigative Site
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Yorkshire
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Strensall, Yorkshire, Royaume-Uni, YO32 5UA
- Novartis Investigative Site
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Bratislava, Slovaquie, 826 06
- Novartis Investigative Site
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Kosice, Slovaquie, 040 01
- Novartis Investigative Site
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Kralovsky Chlmec, Slovaquie, 077 01
- Novartis Investigative Site
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Slovak Republic
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Bardejov, Slovak Republic, Slovaquie, 085 01
- Novartis Investigative Site
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Bojnice, Slovak Republic, Slovaquie, 972 01
- Novartis Investigative Site
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Liptovsky Hradok, Slovak Republic, Slovaquie, 033 01
- Novartis Investigative Site
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Slovensko
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Námestovo, Slovensko, Slovaquie, 02901
- Novartis Investigative Site
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Ankara, Turquie, 06490
- Novartis Investigative Site
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Istanbul, Turquie, 34854
- Novartis Investigative Site
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Istanbul, Turquie
- Novartis Investigative Site
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Kocaeli, Turquie, 41380
- Novartis Investigative Site
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Mersin, Turquie, 33079
- Novartis Investigative Site
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Yenisehir/Izmir, Turquie, 35110
- Novartis Investigative Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: NVA237 + indacaterol
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NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
Autres noms:
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Comparateur placebo: Placebo to NVA237 + indacaterol
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Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Trough Forced Expiratory Volume at 1 Second (FEV1)
Délai: 12 weeks
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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.
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12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose
Délai: 12 weeks
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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.
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12 weeks
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Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks
Délai: 12 weeks
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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.
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12 weeks
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FEV1 at Individual Time-points
Délai: Day 1, Day 29, Day 57 and Days 84/85
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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.
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Day 1, Day 29, Day 57 and Days 84/85
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Forced Vital Capacity (FVC) at Individual Time-points
Délai: Day 1, Day 29, Day 57 and Days 84/85
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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.
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Day 1, Day 29, Day 57 and Days 84/85
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Inspiratory Capacity (IC) at Individual Time-points
Délai: Day 1, Days 84/85
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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.
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Day 1, Days 84/85
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Change From Baseline in Mean Daily Number of Puffs of Rescue Medication
Délai: Baseline, 12 weeks
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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.
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Baseline, 12 weeks
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Transitional Dyspnea Index (TDI) Focal Score
Délai: baseline, 12 weeks
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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.
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baseline, 12 weeks
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Change From Baseline in Mean Daily Total and Individual Symptom Scores
Délai: Baseline, 12 weeks
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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).
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Baseline, 12 weeks
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Number of Participants With Adverse Events and Serious Adverse Events
Délai: 12 weeks
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All study emergent adverse events including Chronic Obstructive Pulmonary Disease exacerbations were monitored from screening through the end of study.
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12 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mai 2012
Achèvement primaire (Réel)
1 janvier 2013
Achèvement de l'étude (Réel)
1 janvier 2013
Dates d'inscription aux études
Première soumission
21 mai 2012
Première soumission répondant aux critères de contrôle qualité
21 mai 2012
Première publication (Estimation)
23 mai 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
14 novembre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 novembre 2014
Dernière vérification
1 novembre 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Maladies pulmonaires
- Maladies pulmonaires obstructives
- Maladie pulmonaire obstructive chronique
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Antagonistes muscariniques
- Antagonistes cholinergiques
- Agents cholinergiques
- Adjuvants, Anesthésie
- Anticonvulsivants
- Glycopyrrolate
- Bromures
Autres numéros d'identification d'étude
- CNVA237A2316
- 2011-005673-23 (Numéro EudraCT)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .