N/A N=190 Randomized Treatment

Pulmonx Endobronchial Valves Used in Treatment of Emphysema (LIBERATE Study)

Emphysema

Bottom Line

View on ClinicalTrials.gov: NCT01796392 ↗

Enrolled (actual)

190

Serious AEs

53.2%

Results posted

Mar 2019

Primary outcome: Primary: Forced Expiratory Volume in 1-second (FEV1) — 61; 10 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EBV (Device); Optimal Medical Management (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Pulmonx Corporation
Primary completion: Sep 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

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.