N/A
Completed N=190
Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)
Source: ClinicalTrials.gov NCT01796392 ↗Enrolled (actual)
190
Serious AEs
53.2%
Results posted
Mar 2019
Primary outcomePrimary: Forced Expiratory Volume in 1-second (FEV1) — 61; 10 Participants
Summary
The purpose of this research is to study an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in 1-second (FEV1) |
61; 10 | — |
| SECONDARY FEV1 Post-bronchodilator Absolute Change |
0.1; -0.003 | — |
| SECONDARY St. George's Respiratory Questionnaire (SGRQ) |
-7.6; -0.5 | — |
| SECONDARY 6-minute Walk Distance |
13.0; -26.3 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical and radiological evidence of emphysema
- Nonsmoking for 4 months prior to screening interview
- BMI less than 35 kg/m2
- Stable on current medication regimen
- Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
- Residual Volume less than 175% predicted (determined by body plethysmography)
- Little or no collateral ventilation (CV-) as determined using the Chartis System
Exclusion Criteria
- Had two or more hospitalizations over the last year for a COPD exacerbation
- Had two or more hospitalizations over the last year for pneumonia
- Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
- Had a heart attack or congestive heart failure within the last 6 months
- Have heart arrhythmia
- Is alpha-1 antitrypsin deficient
Data sourced from ClinicalTrials.gov (NCT01796392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.