Clinical trial NCT00630227: Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study
Official title: Phase 2 Study of the 20 mL Biologic Lung Volume Reduction (BLVR) System in Patients With Homogeneous or Upper Lobe Predominant Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Homogeneous Emphysema
Keywords: emphysema
chronic obstructive pulmonary disease
lung volume reduction
Lead sponsor: Aeris Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-03-06
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also eligible for participation.

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. In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery (LVRS) involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. LVRS, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.

Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System which is intended to achieve lung volume reduction without surgery and its attendant risks. Patients are treated using a bronchoscope to direct treatment to the most damaged areas of the lung or in the case of homogeneous disease, areas that are less active as shown by the extent of regional blood flow. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a biodegradable hydrogel. The hydrogel acts to reduce lung volume by permanently collapsing and sealing the treated areas of the lung. This provides room within the chest to allow the remaining portions of the lung to function better.

Aeris' BLVR development program has been granted Fast Track designation by the U.S. FDA, and is the subject of ongoing clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous (upper lobe predominant) emphysema. Fast Track designation is reserved for drug and biologic development programs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of advanced homogeneous or upper lobe predominant emphysema demonstrated by CT scan
* age \>/= 40 years
* clinically significant dyspnea
* failure of standard medical therapy (typically inhaled beta agonist \& inhaled anticholinergic) to relieve symptoms
* pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 \< 45% predicted \& experiencing \< 30% or 300 mL improvement using bronchodilator; total lung capacity \> 110% predicted; residual volume \> 150% predicted)
* 6 Minute Walk Distance \>/= 150 m

Exclusion Criteria:

* tobacco use within 4 months of initial visit or during study
* body mass index \< 15 kg/m2 or\> 35 kg/m2
* clinically significant asthma, chronic bronchitis or bronchiectasis
* allergy or sensitivity to procedural components
* pregnant, lactating or unwilling to use birth control if required
* prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endotracheal valve placement, airway stent placement or pleurodesis
* comorbid condition that could adversely influence outcomes
* inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
* history of renal infarction or renal failure lung perfusion scan indicating \> 20% of blood flow to either upper lung field or 30% total to both upper lung fields if homogeneous emphysema

Primary outcomes:
measure: reduction in gas trapping
timeFrame: 12 weeks post treatment
Secondary outcomes:
measure: improvement in exercise capacity
timeFrame: 12 weeks post treatment
measure: improvement in expiratory flow
timeFrame: 12 weeks post treatment
measure: improvement in vital capacity
timeFrame: 12 weeks post treatment
measure: improvement in dyspnea sysmptoms
timeFrame: 12 weeks post treatment
measure: improvemnet in respiratory quality of life
timeFrame: 12 weeks post treatment
measure: serious adverse events
timeFrame: through 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Topeka
country: United States
facility: Veritas Clinical Specialties
state: Kansas
city: Towson
country: United States
facility: St Josephs Medical Center
state: Maryland
city: Akron
country: United States
facility: Akron Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation, Pulmonary Allergy & Critical Care Medicine
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Lung Center
state: Pennsylvania
Study officials:
affiliation: Pulmonary Associates, Phoenix, AZ
name: Mark Gotfried, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama, Birmingham, AL
name: Mark Dransfield, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University Lung Center, Philadelphia, PA
name: Gerard Criner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Veritas Clinical Specialties, Topeka, KS
name: William Leeds, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: St Josephs Medical Center, Towson, MD
name: Mark Krasna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic, Cleveland, OH
name: Thomas Gildea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Akron Medical Center, Akron, OH
name: Sanjiv Tewari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa Hospitals & Clinics, Iowa City, IA
name: Geoffrey McLennan, 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.
citation: Reilly J, Washko G, Pinto-Plata V, Velez E, Kenney L, Berger R, Celli B. Biological lung volume reduction: a new bronchoscopic therapy for advanced emphysema. Chest. 2007 Apr;131(4):1108-13. doi: 10.1378/chest.06-1754.