Bronchoscopic Lung Volume Reduction Using Blood
A Randomised, Double Blind, Sham Controlled Trial of Autologous Blood Lung Volume Reduction
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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London, Royaume-Uni
- Chelsea and Westminster NHS Foundation Trust
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Comparateur factice: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Evidence of scarring and volume loss on CT scanning
Délai: 6 weeks
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6 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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To ensure no significant lung function deteriorations at 6 weeks post-procedure
Délai: 6 weeks
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6 weeks
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Pallav Shah, MBBS, MD, Chelsea and Westminster Hospital NHS Foundation Trust
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 08/H0708/100
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