A randomized, double-blind study to evaluate the safety and effectiveness of the Exhale Drug-eluting stent in homogeneous emphysema subjects with severe hyperinflation, the EASE - study. & Local ammendment: Protocol revision to evaluate the ExhaleUltraNeedle in the EASE study.
Phase 3
Completed
- Conditions
- COPDEmphysema10038716
- Registration Number
- NL-OMON30701
- Lead Sponsor
- Broncus Technologies Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
Homogenous emphysema on CT-thorax
Post-bronchodilitator <50% pred or <1 liter
Post-bronchodilitator FEV1/FVC ratio <70%
Post-bronchodilitator RV/TLC ratio >0,65
no smoking
Exclusion Criteria
Recurrent pulmonary infections and bronchiectasis
Cardiovasculair pathology
PaCO2 >60mmHg
Alpha-1 antitrypsin deficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety: The primary safety endpoint is comparison of a composite endpoint<br /><br>between the treatment and control arms.<br /><br>Efficacy: There are two primary efficacy outcomes, FVC and mMRC, which are<br /><br>combined in a responder analysis. A subject is a success (responder) if their<br /><br>FVC improves by at least 12% of their baseline value and their mMRC improves<br /><br>(is reduced) by at least 1 point at their 6-month follow-up visit. In order<br /><br>for superior efficacy to be claimed, the probability of a subject being a<br /><br>responder in the treatment arm must be greater than the control arm. The<br /><br>primary efficacy analysis will be on an intent-to-treat basis on all randomized<br /><br>subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Residual Volume<br /><br>Residual Volume/Totale Long Capaciteit ratio<br /><br>Forced Vital Capacity (FVC)<br /><br>modified Medical Research Counsil Dyspnea Scale (mMRC)<br /><br>Forced Expiratory Volume in 1 second (FEV1)<br /><br>St. George's Respiratory Questionnaire (SGRQ)^<br /><br>6-minute walk distance<br /><br>Cycle ergometry<br /><br><br /><br>In ammendement 7.0-UN:<br /><br>Safety and performance of the ExhaleUltraNeedle</p><br>