Clinical Trial to Evaluate the Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung
lung volume reduction using the Zephyr device
Processus pathologiques
+ Conditions pathologiques, signes et symptômes
+ Emphysème
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 2012
Date à laquelle le premier participant a commencé l'étude.Emphysema is a progressive pulmonary disease characterized by abnormal and permanent enlargement of air spaces distal to terminal bronchioles accompanied by the destruction of pulmonary parenchyma. Treatment includes inhaled bronchodilator therapy, rehabilitation and/or oxygen treatment. In addition to the above, patients with severe emphysema may benefit from surgical lung volume reduction and/or lung transplantation. The rationale for lung volume reduction surgery is that reducing lung size would restore elastic recoil of the lung and improve chest wall and diaphragm mechanics. It has previously been shown that particularly patients with heterogeneous emphysema seem to benefit most from surgical lung volume reduction. Bronchoscopic lung volume reduction (BLVR) has recently been introduced as a less invasive potential alternative to surgical lung volume reduction. BLVR attempts to achieve the effects of surgery, by placing bronchial prostheses using a fibreoptic bronchoscope to selectively occlude the airways supplying the most affected hyperinflated regions of the emphysematous lung, while permitting exhaled gas to escape. This attempts to achieve segmental or lobar volume reduction, simulating the effects of surgical LVR. The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.15 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 65 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: Single lung transplantation due to emphysema at least six months following transplantation that developed native lung overinflation Age from 40 to 75 years BMI < 32 kg/m2 FEV1 < 40% of predicted value, FEV1/FVC < 70% TLC > 120% predicted, RV > 150% predicted. Stable with < 20 mg prednisone (or equivalent) qd PaCO2 < 50mm Hg PaO2 > 45 mm Hg on room air 6-min walk of > 50m (without rehabilitation) or > 100m (with rehabilitation) Nonsmoking for 4 months prior to initial interview and throughout screening The patient agrees to all protocol required follow-up intervals. The patient has no child bearing potential The patient is willing and able to complete protocol required baseline assessments and procedures Exclusion criteria Prior endobronchial treatment for emphysema Pleural or interstitial disease that precludes surgery. Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy. Clinically significant bronchiectasis Pulmonary nodule requiring surgery History of recurrent respiratory infections (> 3 hospitalization in the last year) Clinically significant (> 4 Tablespoons per day) sputum production Fever, elevated white cell count, or other evidence of active infection Dysrhythmia that might pose a risk during exercise or training Congestive heart failure within 6 mo and LVEF < 45% Evidence or history of Cor Pulmonale Resting bradycardia (< 50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT History of exercise-related syncope MI within 6 mo and LVEF < 45% Evidence of systemic disease or neoplasia expected to compromise survival during 5-yr period Any disease or condition that interferes with completion of initial or follow-up assessments Patient is currently enrolled in another clinical trial Patient is unable to complete 3 minutes of unloaded peddling on cycle ergometer Alpha-1-Antitrypsin Deficiency
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Un seul groupe d'intervention est désigné dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site