Bronchoscopic Lung Volume Reduction Using Blood
A Randomised, Double Blind, Sham Controlled Trial of Autologous Blood Lung Volume Reduction
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This will be a randomised, double blind, placebo controlled trial where the response in patients treated with blood LVR will be compared to patients treated with placebo (control group). Analysis will evaluate the mean change in lobar lung volumes as determined by computed tomography (CT) scanning at 6 weeks in two study arms based on subjects' blinded bronchoscopic intervention.
Initial assessment will comprise
- Clinical evaluation
- Full pulmonary function tests (PFTs) - static and dynamic lung volumes and gas transfer
- SGRQ
- Dyspnoea Score
- CT scan
Suitable patients will then be randomised to receive either autologous blood, or normal saline injected into the target airways.
Procedures in all patients will be carried out under conscious sedation and/or anaesthesia. After bronchoscopic examination of the airways, 100ml of the patients own blood will be collected using two 50ml syringes. A balloon catheter will be inserted into the target segment and 25 mls of the blood will be injected via the balloon catheter. The balloon will be inflated and maintained in position for about 6 minutes in order to minimise the risk of overspill of blood into other areas of the lung. The balloon catheter will then be repositioned in the next segment of the target lobe of the lung and the process repeated until all the segments are treated. It is anticipated that the whole procedure will last 45-60 minutes, up to and including balloon removal.
The placebo arm will involve an identical protocol, except that injections of 30mls of 0.9% saline will replace the injections of blood. 3 segments will be 'treated'. The blood retrieved at the start of the procedure will be discarded.
A course of antibiotics or pulse of corticosteroids after the procedure will be at the discretion of the investigator. Post-operative CXRs will only be ordered if there are clinical indications (e.g. cough, fever, increased breathlessness).
Reassessment will occur at 6 weeks. This will be undertaken by a blinded assessment team with no knowledge of which study arm a patient has been randomised into, and with no access to the initial procedure record. This removes expectation and subjectivity from the assessment. Assessment will consist of the following:
- Clinical evaluation
- Full pulmonary function tests (PFTs) - static and dynamic lung volumes and gas transfer
- SGRQ
- Dyspnoea Score
- Blinding questionnaire for patient and assessment team
- CT scan
After the assessments have been completed the patients will be un-blinded and informed which treatment group they had been assigned to.
Subjects will be made aware that the process is expected to be irreversible. However, if there are any problems during the bronchoscopy (for example worsening hypoxia), then the procedure will be abandoned as soon as it is safe to do so.
A log of adverse and serious adverse events for each patient will be kept as part of the safety monitoring of the trial.
Those who are entered into the control arm of the study will be offered the real procedure at the end of the study if benefits are apparent
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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London, Reino Unido
- Chelsea and Westminster NHS Foundation Trust
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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:
- Age 18-80 years
- Moderate to severe airflow obstruction FEV1 <50% Predicted
- Severe dyspnoea - mMRC ≥2
- Hyperinflation - total lung capacity (TLC) ≥100% predicted, RV ≥150% predicted
- Optimum COPD treatment for at least 6 weeks
- No COPD exacerbation for at least 6 weeks
- Less than 3 admissions for exacerbation in the preceding 12 months
Exclusion Criteria:
- Patient unable to provide informed consent
- Total lung CO uptake (TLCO) <15% predicted and FEV1 <15% predicted
- pO2 on air <6.0kPa
- pCO2 on air >8.0kPa
- Other major medical illness, e.g. lung cancer that will limit participation
- Clinically significant bronchiectasis
- Large bulla - more than 1/3 of hemithorax volume (i.e. where bullectomy would be more suitable) on CT scan
- Arrhythmia or cardiovascular disease that poses a risk during procedure
- Prednisolone dose greater than 10mg a day
- Prior LVRS or lobectomy
- Lung nodule requiring surgery
- Female of childbearing age with positive pregnancy test
- Subject participated in a research study of investigational drug or device in prior 30 days
- Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Autologous blood
Patients will have 50mls of autologous blood injected into each of 3 bronchopulmonary segments during bronchoscopy under conscious sedation.
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50mls of autologous blood injected into each of 3 bronchopulmonary segments.
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Comparador Falso: Saline
Patients will have 50mls of normal saline injected into each of 3 bronchopulmonary segments during bronchoscopy under conscious sedation.
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50mls of normal saline injected into each of 3 bronchopulmonary segments.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Evidence of scarring and volume loss on CT scanning
Prazo: 6 weeks
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6 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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To ensure no significant lung function deteriorations at 6 weeks post-procedure
Prazo: 6 weeks
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6 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Pallav Shah, MBBS, MD, Chelsea and Westminster Hospital NHS Foundation Trust
Publicações e links úteis
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 (Estimativa)
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
- 08/H0708/100
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