BACE Trial Substudy 1 - PROactive Substudy (PROactive)
BACE Trial - Physical Activity as a Crucial Patient Reported Outcome in COPD
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Physical activity is strongly reduced with exacerbations and failure to increase physical activity is associated with relapse. In addition, physical inactivity is known to be associated with cardiovascular and metabolic morbidity and is one of the strongest predictors of mortality in COPD. Apart from potential direct effects of the intervention on treatment failure and symptoms, positive effects on physical activity may offer considerable benefits in the long run.
Randomized patients that are willing to participate in the sub-study will be monitored for activity by validated and easy-to-wear portable devices (Dynaport®). This activity monitor was recently thoroughly validated for use in COPD by the Pro-Active consortium and will be used at the baseline, 3 months and 9 months visit. We hypothesize that with a positive medical intervention, differences in recovery of physical activity will be appreciated.
Patients will follow the standard protocol but will also wear the activity monitor for 7 days post discharge from hospital (at investigator discretion), at day 90 (end of treatment) and at day 270 (end of follow-up). This device is not only registering physical activity for 7 days but is also coupled to a standardized and patient-validated questionnaire on physical activities which needs to be filled out at day 8 to cover a recall period of 7 (monitored) days.
Patient will have to give informed consent for the additional measures that are related to the activity sub-study. However, individual patients can still opt out for these tests (sub-study) and only participate in the medical intervention study (main study).
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Brussels Hoofdstedelijk Gewest
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Brussel, Brussels Hoofdstedelijk Gewest, Bélgica, 1000
- St. Pieterziekenhuis
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Vlaanderen
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Antwerpen, Vlaanderen, Bélgica, 2020
- ZNA Middelheim
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Bonheiden, Vlaanderen, Bélgica, 2820
- Imelda Ziekenhuis
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Gent, Vlaanderen, Bélgica, 9000
- UZ Gent
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Hasselt, Vlaanderen, Bélgica, 3500
- Jessa Ziekenhuis
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Leuven, Vlaanderen, Bélgica, 3000
- UZ Gasthuisberg
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test)
- Smoking history of at least 10 pack-years (10 pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc.)
- Current hospitalization for potential infectious AECOPD treated with standard therapy
- History of at least one exacerbation during the last year (prior to the current hospital admission) for which systemic steroids and/or antibiotics were taken
- ECG at admission
Exclusion Criteria:
- Mechanical or non-invasive ventilation at moment of randomization (D1)
- Long QT interval on ECG (QTc > 450msec for males or > 470msec for females)
- History of life-threatening arrhythmias
- Myocardial infarction (NSTEMI or STEMI) less than 6 weeks before start of study drug
- Unstable angina pectoris or acute myocardial infarction (NSTEMI or STEMI) at admission
- Drugs with high risk for long QT interval and torsade de pointes (amiodarone, flecainide, procainamide, sotalol, droperidol, haldol, citalopram, other macrolides)
- Documented uncorrected severe hypokalemia (K+ < 3.0 mmol/L) or hypomagnesemia (Mg2+ < 0.5 mmol/L)
- Chronic systemic steroids (> 4 mg methylprednisolone /day for ≥ 2 months)
- Actual use of macrolides for at least 2 weeks
- Allergy to macrolides
- Active cancer treatment
- Life expectancy < 3 months
- Pregnant or breast-feeding subjects. Woman of childbearing potential must have a pregnancy test performed and a negative result must be documented before start of treatment
Plano de estudo
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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Experimental: Azithromycin
N = 250 From day 1 up to and including day 3: 500 mg azithromycin PO once a day From day 4 up to and including day 90: 250 mg azithromycin PO once every 2 days N= 30 During 7 days post discharge from hospital (0 months), 3 months and 9 months, the patient will wear the Dynaport® which will register the patient's physical activity |
Do dia 1 até o dia 3 inclusive: 500 mg de azitromicina ou placebo PO uma vez ao dia Do dia 4 até o dia 90 inclusive: 250 mg de azitromicina ou placebo PO uma vez a cada 2 dias
Outros nomes:
Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months
Outros nomes:
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Comparador de Placebo: Placebo
N = 250 From day 1 up to and including day 3: 500 mg placebo PO once a day From day 4 up to and including day 90: 250 mg placebo PO once every 2 days N= 30 During 7 days post discharge from hospital (0 months), 3 months and 9 months, the patient will wear the Dynaport® which will register the patient's physical activity |
Outros nomes:
Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Difference in Physical Activity (total amount of steps) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 3 months after randomisation
Prazo: At discharge from hospital (0 months) and 3 months after start study drug intake
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Physical activity will be quantified as Total amount of steps
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At discharge from hospital (0 months) and 3 months after start study drug intake
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Key secondary endpoint: Different change in physical activity (total amount of steps) at 3 months between placebo and azithromycin arm
Prazo: 0 and 3 months
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Difference between placebo and azithromycin arm in physical activity changes registered by the Dynaport® during 7 days at discharge from hospital (0 months) and at 3 months
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0 and 3 months
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Different change in physical activity (total amount of steps) at 9 months between placebo and azithromycin arm
Prazo: at baseline and 9 months
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Difference between placebo and azithromycin arm in physical activity changes registered by the Dynaport® during 7 days at discharge from hospital (0 months) and at 9 months
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at baseline and 9 months
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Difference in Physical Activity (TSMVA) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 9 months, or between 3 months and 9 months after randomisation
Prazo: baseline, 3 and 9 months
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Physical activity will be specified for:
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baseline, 3 and 9 months
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Difference in Physical Activity (TSMVA) registered by the Dynaport® during 7 days between discharge from hospital (0 months) and 3 months after randomisation
Prazo: At discharge from hospital (0 months) and 3 months after start study drug intake
|
Physical activity will be specified for:
|
At discharge from hospital (0 months) and 3 months after start study drug intake
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Exploratory endpoint: sensitivity analysis of primary and secondary endpoints in subgroups
Prazo: at 0, 3 and 9 months
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at 0, 3 and 9 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Wim Janssens, MD PhD, KU Leuven
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- s55829 - PROactive Substudy
Plano para dados de participantes individuais (IPD)
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