Please select the eligibility criteria that correspond to the clinical trial below.
Title: Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.
Brief Summary: * 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.


Options:
A: Inclusion Criteria:

* clinical diagnosis of advanced upper lobe predominant emphysema
* age \>/= 40 years
* clinically significant dyspnea
* failure of standard medical therapy to relieve symptoms (inhaled beta agonist and inhaled anticholinergic)
* pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 \< 45% predicted and experiencing \< 30% or 300 mL improvement using bronchodilator; TLC \> 110% predicted; RV \> 150% predicted)
* 6 Minute Walk Distance \>/= 150 m

Exclusion Criteria:

* alpha-1 protease inhibitor deficiency
* homogeneous disease
* tobacco use within 4 months of initial visit
* body mass index \< 15 kg/m2 or \> 35 kg/m2
* clinically significant asthma, chronic bronchitis or bronchiectasis
* allergy or sensitivity to procedural components
* pregnant, lactating or unwilling to use birth control if required
* prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endobronchial valve placement, airway stent placement or pleurodesis
* comorbid condition that could adversely influence outcomes
* inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
B: Inclusion Criteria:

1. High resolution computed tomography (CT) scan evidence of homogeneous emphysema.
2. Stopped smoking at least 8 weeks before entering the trial.
3. Post-bronchodilator RV/TLC ≥ 0.65.
4. Post-bronchodilator Forced Expiratory Volume (FEV1) ≤ 50% or FEV1 \< 1 liter.
5. Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4.
6. Patient has undergone supervised pulmonary rehabilitation of 16-20 sessions over 6-10 weeks.

Exclusion Criteria:

1. Change in FEV1 \> 20% pre- and post- bronchodilator measurements or \> 200 ml if post-bronchodilator FEV1 \< 1 liter.
2. Respiratory infections requiring 3 or more hospitalizations in past year.
3. Inability to walk \> 140 meters (150 yards) in 6 minutes.
4. Previous lung volume reduction surgery (LVRS) or lobectomy.
C: Inclusion Criteria:

* Between 40 and 74 years of age
* Predominantly upper lobe emphysema and severe dyspnea
* Satisfies the criteria of the ATS/ERS Guidelines for Management of Stable COPD
* Physical ability to participate in the study by performing a 6-minute walk distance of \> 140m
* No cigarette smoking for 4 months and willing to abstain throughout the study
* Severe airflow obstruction defined by FEV1 45% of predicted
* Severe hyperinflation defined by: TLC \> 100% of predicted and RV \> 150% of predicted

Exclusion Criteria:

* Between 70 and 74 years of age and an FEV1 or DLCO \< 20% of predicted
* Severe gas exchange abnormalities
* Major medical disease that will limit evaluation, participation or follow-up
* Active asthma component to their disease
* Giant bulla (\> 1/3 volume of lung)
* Severe pulmonary hypertension
* Requirement for \> 6L02 to keep saturation \> 90% with exercise
* Evidence of systemic disease or neoplasia expected to compromise survival during the 6-month study period
D: 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

Answer: D