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 novembro de 2014 atualizado 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
449
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Pleven, Bulgária, 5800
- Novartis Investigative Site
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Plovdiv, Bulgária, 4002
- Novartis Investigative Site
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Ruse, Bulgária, 7002
- Novartis Investigative Site
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Sofia, Bulgária, 1431
- Novartis Investigative Site
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Sofia, Bulgária, 1606
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Sofia, Bulgária, 1000
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Stara Zagora, Bulgária, 6000
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Varna, Bulgária, 9010
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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
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Gilly, Bélgica, 6060
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Gosselies, Bélgica, 6041
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Hasselt, Bélgica, 3500
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Herentals, Bélgica, 2200
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Jambes, Bélgica, 5100
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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
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Yvoir, Bélgica, 5530
- Novartis Investigative Site
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Bratislava, Eslováquia, 826 06
- Novartis Investigative Site
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Kosice, Eslováquia, 040 01
- Novartis Investigative Site
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Kralovsky Chlmec, Eslováquia, 077 01
- Novartis Investigative Site
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Slovak Republic
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Bardejov, Slovak Republic, Eslováquia, 085 01
- Novartis Investigative Site
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Bojnice, Slovak Republic, Eslováquia, 972 01
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Liptovsky Hradok, Slovak Republic, Eslováquia, 033 01
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Slovensko
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Námestovo, Slovensko, Eslováquia, 02901
- Novartis Investigative Site
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Barcelona, Espanha, 08025
- Novartis Investigative Site
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Andalucia
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Malaga, Andalucia, Espanha, 29010
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Asturias
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Gijon, Asturias, Espanha, 33290
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Cantabria
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Torrelavega, Cantabria, Espanha, 39300
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Castilla la Mancha
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Illescas, Castilla la Mancha, Espanha, 45200
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Castilla y Leon
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Ponferrada, Castilla y Leon, Espanha, 24400
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Cataluña
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Centelles, Cataluña, Espanha, 08540
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Salt, Cataluña, Espanha, 17190
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Sant Boi de Llobregat, Cataluña, Espanha, 08830
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Viladecans, Cataluña, Espanha
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Extremadura
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Mérida, Extremadura, Espanha, 06800
- Novartis Investigative Site
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Moscow, Federação Russa, 125315
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N.Novgorod, Federação Russa, 603126
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Nizhny Novgorod, Federação Russa, 603018
- Novartis Investigative Site
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Saratov, Federação Russa, 410012
- Novartis Investigative Site
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Athens, Grécia, 11527
- Novartis Investigative Site
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GR
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Athens, GR, Grécia, 115 27
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Athens, GR, Grécia, 106 76
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Thessaloniki, GR, Grécia, 564 03
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Budapest, Hungria, 1121
- Novartis Investigative Site
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Budapest, Hungria, 1046
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Deszk, Hungria, 6772
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Erd, Hungria, H-2030
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Godollo, Hungria, 2100
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Cork
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Wilton, Cork, Irlanda
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Ankara, Peru, 06490
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Istanbul, Peru, 34854
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Istanbul, Peru
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Kocaeli, Peru, 41380
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Mersin, Peru, 33079
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Yenisehir/Izmir, Peru, 35110
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Bath, Reino Unido, BA1 2SR
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Bexhill-on-Sea, Reino Unido, TN40 1JJ
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Blackpool, Reino Unido, FY3 7EN
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Bradford, Reino Unido, BD9 6RJ
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Cambridge, Reino Unido, CB7 5JD
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Chesterfield, Reino Unido, S40 4AA
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Huntingdon, Reino Unido, PE29 6NT
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Manchester, Reino Unido, M20 2RN
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Newcastle-upon-Tyne, Reino Unido, NE7 7DN
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Newton Aycliffe, Reino Unido, DL5 4SE
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Reading, Reino Unido, RG7 3SQ
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Southbourne, Reino Unido
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Telford, Reino Unido, TF1 6TF
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Watford, Reino Unido, WD25 0EA
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Wiltshire, Reino Unido, SN15 2SB
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County Durham
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Burnhope, County Durham, Reino Unido, DH7 0BD
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Suffolk
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Alderton, Suffolk, Reino Unido, IP12 3DA
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Warwickshire
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Atherstone, Warwickshire, Reino Unido, CV9 1EU
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Leamington Spa, Warwickshire, Reino Unido, CV32 4RA
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Yorkshire
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Strensall, Yorkshire, Reino Unido, YO32 5UA
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
40 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: NVA237 + indacaterol
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NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
Outros nomes:
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Comparador de 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Trough Forced Expiratory Volume at 1 Second (FEV1)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2012
Conclusão Primária (Real)
1 de janeiro de 2013
Conclusão do estudo (Real)
1 de janeiro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
21 de maio de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de maio de 2012
Primeira postagem (Estimativa)
23 de maio de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
14 de novembro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de novembro de 2014
Última verificação
1 de novembro de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Respiratórias
- Doenças pulmonares
- Doenças Pulmonares Obstrutivas
- Doença Pulmonar Obstrutiva Crônica
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Antagonistas Muscarínicos
- Antagonistas colinérgicos
- Agentes colinérgicos
- Adjuvantes, Anestesia
- Anticonvulsivantes
- Glicopirrolato
- Brometos
Outros números de identificação do estudo
- CNVA237A2316
- 2011-005673-23 (Número EudraCT)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em NVA237 50 µg and indacaterol 150 µg
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Novartis PharmaceuticalsConcluídoDoença de obstrução pulmonar crônicaEstados Unidos, Alemanha, Hungria, Bélgica, Polônia, Espanha, Holanda
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Novartis PharmaceuticalsConcluído
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Universiteit AntwerpenConcluídoCOVID-19 | Doença do coronavírus 2019Bélgica
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SkinJect, Inc.Rescindido
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Novartis PharmaceuticalsConcluídoDoença Pulmonar Obstrutiva Crônica (DPOC)Estados Unidos, Alemanha, Espanha, Peru, Hungria, República Checa, Índia, Eslováquia
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BlueWillow BiologicsPorton Biopharma Ltd.Concluído
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Aalborg UniversityConcluídoCoceira | Papaína | Teste de picada na pele (SPT)Dinamarca
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U.S. Army Medical Research and Development CommandWalter Reed Army Institute of Research (WRAIR); Henry M. Jackson Foundation...Ativo, não recrutandoInfecção por SARS-CoV-2Estados Unidos
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Butantan InstituteInCor - Instituto do Coração - HCFMUSP.Retirado