* BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be feasible and associated with an acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity and lung function. The objective of this study is to analyze the cost effectiveness of LVRC treatment in severe emphysema. * METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs conventional treatment) will include 100 patients who will be followed up for 1year. The primary outcome measure is the 6-month improvement of the 6-minute walk test: the percentage of patients showing an improvement of at least 54m will be compared between groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global cost of this therapeutic option and will compare the cost between patients treated by LVRC and by medical treatment alone. * EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in severe emphysema. The cost-effectiveness study will assess the medical-economic impact of the LVRC therapeutic option.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
CHU d'Amiens
Amiens, France
CHU de Grenoble
Grenoble, France
AP-HM
Marseille, France
CHU de Montpellier
Montpellier, France
CHU de Nice
Nice, France
AP-HP - Hôpital Bichat
Paris, France
CHU de Rouen
Rouen, France
CHU de Saint-Etienne
Saint-Priest-en-Jarez, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
6-month improvement of the 6-minute walk test
6-month improvement of the 6-minute walk test : the percentage of patients showing an improvement of at least 54m will be compared between groups.
Time frame: 6 months
Cost-effectiveness
Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores.
Time frame: 6 and 12 months
Dyspnea
Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale
Time frame: 6 and 12 months
Pulmonary function assessment
Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC.
Time frame: 6 and 12 months
Quality of life
Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions)
Time frame: 6 and 12 months
Morbidity-mortality
Comparison of mortality and severe adverse events using a composite score (death, haemoptysis \> 150 cc, pneumonia requiring hospitalization, pneumothorax requiring chest tube drainage \> 7 days, mechanical ventilation \> 24 hours, lung transplantation).
Time frame: 6 and 12 months
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