Lung Volume Reduction Coil Treatment in Emphysema.

Study Overview
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Brief Summary
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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.

Official Title
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Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.

Conditions
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Emphysema

Intervention / Treatment
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* Procedure: Lung volume reduction coïl treatment
* Other: Regular medical treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral emphysema on Chest CT Scanner Post bronchodilator FEV1 < 50 % Total Lung Capacity > 100 % Residual Volume > 220 % Dyspnea score between 2 and 4 based on the mMRC scale Stopped cigarette smoking for more than 8 weeks Pulmonary rehabilitation within the previous twelve months Consent form signed Covered by Medical Insurance Exclusion Criteria: Post bronchodilator FEV1 < 15% Post-bronchodilator change in FEV1 > 20% Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months COPD exacerbation requiring hospital stay within 3 months Pulmonary Hypertension (Pulmonary systolic pressure >50 mmHg on cardiac echo) Patient unable to perform a 6-min walking test in room air Giant bulla of more than 1/3 of the lung field on Chest CT Strictly homogeneous emphysema on Chest CT Clinically significant bronchiectasis Past history of lobectomy, lung volume reduction surgery, lung transplantation Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…) Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up Contra-indication to general anesthesia Oral anticoagulant treatment (antivitamin K) Allergy to nitinol Inclusion in an other study assessing respiratory treatments Patient protected by the law

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung volume reduction coïl treatment<br>Lung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention | Procedure: Lung volume reduction coïl treatment<br> <br> Other: Regular medical treatment<br> <br> |
| Other: Regular Medical Treatment<br>No intervention, just a follow up under usual medical treatment | Other: Regular medical treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness | Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores. | 6 and 12 months | 
| Dyspnea | Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale | 6 and 12 months | 
| Pulmonary function assessment | Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC. | 6 and 12 months | 
| Quality of life | Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions) | 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). | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive pulmonary disease, Endoscopic lung volume reduction