Overview

This trial is active, not recruiting.

Condition emphysema
Treatments lung volume reduction coïl treatment, regular medical treatment
Phase phase 3
Sponsor CHU de Reims
Collaborator PneumRx, Inc.
Start date March 2013
End date March 2015
Trial size 100 participants
Trial identifier NCT01822795, PD12133

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Lung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention
lung volume reduction coïl treatment
regular medical treatment
(Other)
No intervention, just a follow up under usual medical treatment
regular medical treatment

Primary Outcomes

Measure
6-month improvement of the 6-minute walk test
time frame: 6 months

Secondary Outcomes

Measure
Cost-effectiveness
time frame: 6 and 12 months
Dyspnea
time frame: 6 and 12 months
Pulmonary function assessment
time frame: 6 and 12 months
Quality of life
time frame: 6 and 12 months
Morbidity-mortality
time frame: 6 and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.
Principal investigator Gaëtan DESLEE, PhD, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by CHU de Reims.