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 de noviembre de 2014 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
449
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Pleven, Bulgaria, 5800
- Novartis Investigative Site
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Plovdiv, Bulgaria, 4002
- Novartis Investigative Site
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Ruse, Bulgaria, 7002
- Novartis Investigative Site
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Sofia, Bulgaria, 1431
- Novartis Investigative Site
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Sofia, Bulgaria, 1606
- Novartis Investigative Site
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Sofia, Bulgaria, 1000
- Novartis Investigative Site
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Stara Zagora, Bulgaria, 6000
- Novartis Investigative Site
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Varna, Bulgaria, 9010
- Novartis Investigative Site
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Brussel, Bélgica, 1090
- Novartis Investigative Site
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Bruxelles, Bélgica, 1070
- Novartis Investigative Site
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Genk, Bélgica, 3600
- Novartis Investigative Site
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Gilly, Bélgica, 6060
- Novartis Investigative Site
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Gosselies, Bélgica, 6041
- Novartis Investigative Site
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Hasselt, Bélgica, 3500
- Novartis Investigative Site
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Herentals, Bélgica, 2200
- Novartis Investigative Site
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Jambes, Bélgica, 5100
- Novartis Investigative Site
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Liège, Bélgica, 4000
- Novartis Investigative Site
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Luxembourg, Bélgica, 1210
- Novartis Investigative Site
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Malmedy/Bellevaux-Ligneuville, Bélgica, 4960
- Novartis Investigative Site
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Montigny-le-tilleul, Bélgica, 6110
- Novartis Investigative Site
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Turnhout, Bélgica, 2300
- Novartis Investigative Site
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Yvoir, Bélgica, 5530
- Novartis Investigative Site
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Bratislava, Eslovaquia, 826 06
- Novartis Investigative Site
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Kosice, Eslovaquia, 040 01
- Novartis Investigative Site
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Kralovsky Chlmec, Eslovaquia, 077 01
- Novartis Investigative Site
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Slovak Republic
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Bardejov, Slovak Republic, Eslovaquia, 085 01
- Novartis Investigative Site
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Bojnice, Slovak Republic, Eslovaquia, 972 01
- Novartis Investigative Site
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Liptovsky Hradok, Slovak Republic, Eslovaquia, 033 01
- Novartis Investigative Site
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Slovensko
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Námestovo, Slovensko, Eslovaquia, 02901
- Novartis Investigative Site
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Barcelona, España, 08025
- Novartis Investigative Site
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Andalucia
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Malaga, Andalucia, España, 29010
- Novartis Investigative Site
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Asturias
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Gijon, Asturias, España, 33290
- Novartis Investigative Site
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Cantabria
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Torrelavega, Cantabria, España, 39300
- Novartis Investigative Site
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Castilla la Mancha
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Illescas, Castilla la Mancha, España, 45200
- Novartis Investigative Site
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Castilla y Leon
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Ponferrada, Castilla y Leon, España, 24400
- Novartis Investigative Site
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Cataluña
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Centelles, Cataluña, España, 08540
- Novartis Investigative Site
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Salt, Cataluña, España, 17190
- Novartis Investigative Site
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Sant Boi de Llobregat, Cataluña, España, 08830
- Novartis Investigative Site
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Viladecans, Cataluña, España
- Novartis Investigative Site
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Extremadura
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Mérida, Extremadura, España, 06800
- Novartis Investigative Site
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Moscow, Federación Rusa, 125315
- Novartis Investigative Site
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N.Novgorod, Federación Rusa, 603126
- Novartis Investigative Site
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Nizhny Novgorod, Federación Rusa, 603018
- Novartis Investigative Site
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Saratov, Federación Rusa, 410012
- Novartis Investigative Site
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Athens, Grecia, 11527
- Novartis Investigative Site
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GR
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Athens, GR, Grecia, 115 27
- Novartis Investigative Site
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Athens, GR, Grecia, 106 76
- Novartis Investigative Site
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Thessaloniki, GR, Grecia, 564 03
- Novartis Investigative Site
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Budapest, Hungría, 1121
- Novartis Investigative Site
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Budapest, Hungría, 1046
- Novartis Investigative Site
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Deszk, Hungría, 6772
- Novartis Investigative Site
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Erd, Hungría, H-2030
- Novartis Investigative Site
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Godollo, Hungría, 2100
- Novartis Investigative Site
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Cork
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Wilton, Cork, Irlanda
- Novartis Investigative Site
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Ankara, Pavo, 06490
- Novartis Investigative Site
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Istanbul, Pavo, 34854
- Novartis Investigative Site
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Istanbul, Pavo
- Novartis Investigative Site
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Kocaeli, Pavo, 41380
- Novartis Investigative Site
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Mersin, Pavo, 33079
- Novartis Investigative Site
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Yenisehir/Izmir, Pavo, 35110
- Novartis Investigative Site
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Bath, Reino Unido, BA1 2SR
- Novartis Investigative Site
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Bexhill-on-Sea, Reino Unido, TN40 1JJ
- Novartis Investigative Site
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Blackpool, Reino Unido, FY3 7EN
- Novartis Investigative Site
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Bradford, Reino Unido, BD9 6RJ
- Novartis Investigative Site
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Cambridge, Reino Unido, CB7 5JD
- Novartis Investigative Site
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Chesterfield, Reino Unido, S40 4AA
- Novartis Investigative Site
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Huntingdon, Reino Unido, PE29 6NT
- Novartis Investigative Site
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Manchester, Reino Unido, M20 2RN
- Novartis Investigative Site
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Newcastle-upon-Tyne, Reino Unido, NE7 7DN
- Novartis Investigative Site
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Newton Aycliffe, Reino Unido, DL5 4SE
- Novartis Investigative Site
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Reading, Reino Unido, RG7 3SQ
- Novartis Investigative Site
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Southbourne, Reino Unido
- Novartis Investigative Site
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Telford, Reino Unido, TF1 6TF
- Novartis Investigative Site
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Watford, Reino Unido, WD25 0EA
- Novartis Investigative Site
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Wiltshire, Reino Unido, SN15 2SB
- Novartis Investigative Site
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County Durham
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Burnhope, County Durham, Reino Unido, DH7 0BD
- Novartis Investigative Site
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Suffolk
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Alderton, Suffolk, Reino Unido, IP12 3DA
- Novartis Investigative Site
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Warwickshire
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Atherstone, Warwickshire, Reino Unido, CV9 1EU
- Novartis Investigative Site
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Leamington Spa, Warwickshire, Reino Unido, CV32 4RA
- Novartis Investigative Site
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Yorkshire
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Strensall, Yorkshire, Reino Unido, YO32 5UA
- Novartis Investigative Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: NVA237 + indacaterol
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NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
Otros nombres:
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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Trough Forced Expiratory Volume at 1 Second (FEV1)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2012
Finalización primaria (Actual)
1 de enero de 2013
Finalización del estudio (Actual)
1 de enero de 2013
Fechas de registro del estudio
Enviado por primera vez
21 de mayo de 2012
Primero enviado que cumplió con los criterios de control de calidad
21 de mayo de 2012
Publicado por primera vez (Estimar)
23 de mayo de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de noviembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
12 de noviembre de 2014
Última verificación
1 de noviembre de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades Pulmonares Obstructivas
- Enfermedad Pulmonar Obstructiva Crónica
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Antagonistas muscarínicos
- Antagonistas colinérgicos
- Agentes colinérgicos
- Adyuvantes, Anestesia
- Anticonvulsivos
- Glicopirrolato
- Bromuros
Otros números de identificación del estudio
- CNVA237A2316
- 2011-005673-23 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .