Clinical trial NCT00085852: US 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study - Initial Formulation
Official title: Phase 1 Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Heterogeneous Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Emphysema
Keywords: emphysema
chronic obstructive pulmonary disease
lung volume reduction
bronchoscopic
bronchoscopy
bronchoscope
Lead sponsor: Aeris Therapeutics
Sponsor class: INDUSTRY
First posted: 2004-06-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.

Detailed description: Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. Recently, lung volume reduction surgery has become an accepted therapy for emphysema. Lung volume reduction surgery involves the removal of a diseased portion of the lung, which enables the remaining, healthier portions of the lung to function better. This procedure, although effective, is complicated and risky.

Aeris Therapeutics has developed the Aeris Bronchoscopic Lung Volume Reduction System for treatment of patients with advanced emphysema. The Aeris BLVR System is designed to reduce lung volume without surgery. Patients are treated under anesthesia using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment is expected to reduce lung volume by shrinking the diseased areas of the lung. The purpose of the current study is to find out whether the Aeris BLVR System is safe in patients with advanced emphysema. The risks associated with the treatment are expected to be similar to those associated with general anesthesia and bronchoscopy.

Eligibility criteria: Inclusion Criteria:

* Advanced emphysema
* Limited exercise capacity and persistent symptoms despite medical therapy
* Age between 18 and 75
* No significant heart, kidney or liver disease
* Willingness and ability to tolerate bronchoscopy
* No prior Lung Volume Reduction Surgery or Lung Transplantation
* Screening test results indicating that the procedure is appropriate

Primary outcomes:
measure: SAEs - Safety
timeFrame: 1 year post treatment
Secondary outcomes:
measure: PFTs
timeFrame: 12 weeks post treatment
measure: Dyspnea
timeFrame: 12 weeks post treatment
measure: Exercise capacity
timeFrame: 12 weeks post treatment
measure: QOL
timeFrame: 12 weeks post treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Caritas St Elizabeth's Medical Center
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: John J. Reilly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11.