Clinical trial NCT00435253: US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study
Official title: Phase 2 Study of the Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Emphysema
Keywords: emphysema
COPD
lung volume reduction
NETT
BLVR
biologic lung volume reduction
bronchoscopic lung volume reduction
Lead sponsor: Aeris Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-02-14
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.

Detailed description: Prospective, open-label, non-controlled, multi-center Phase 2 Study evaluating the efficacy and safety of the 10 mL BLVR System in patients with advanced upper lobe predominant emphysema. Twenty patients will be divided into 2 groups of 10 patients each and treated under conscious sedation at a total of 8 subsegments. Group 1 will be treated in 4 subsegments in 1 lung and have a second treatment of 4 subsegments in the other lung 6 to 12 weeks later. Group 2 will receive treatment at 8 subsegments (4 in each lung) during a single treatment session if possible; if not completed in 1 session the remaining subsegments will be treated 6 to 12 weeks later. Patients will be followed 96 weeks after completion of the final BLVR treatment. All patients will receive standard medical therapy in addition to BLVR treatment.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* alpha-1 protease inhibitor deficiency
* homogeneous disease
* tobacco use within 4 months of initial visit
* 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, endobronchial valve placement, airway stent placement or pleurodesis
* comorbid condition that could adversely influence outcomes
* inability to tolerate bronchoscopy under conscious sedation (or anesthesia)

Primary outcomes:
measure: Reduction in gas trapping
timeFrame: 12 weeks post treatment
measure: SAEs - Safety of treatment and the procedure
timeFrame: 2 years
Secondary outcomes:
measure: Improvement in vital capacity
timeFrame: 12 weeks post treatment
measure: Improvement in expiratory flow
timeFrame: 12 weeks post treatment
measure: Improvement in inspiratory flow
timeFrame: 12 weeks post treatment
measure: Improvement in dyspnea symptoms (breathlessness)
timeFrame: 12 weeks post treatment
measure: Improvement in exercise capacity
timeFrame: 12 weeks post treatment
measure: Improvement in respiratory quality of life
timeFrame: 12 weeks post treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham Lung Health Center
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Boston
country: United States
facility: Caritas St Elizabeth's Med Cen
state: Massachusetts
city: Philadelphia
country: United States
facility: Temple University Lung Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina Hospital
state: South Carolina
Study officials:
affiliation: Steward St. Elizabeth's Medical Center of Boston, Inc.
name: Victor Pinto-Plata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University Lung Center
name: Gerard Criner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulmonary Associates
name: Mark Gotfried, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Univ South Carolina Hospital
name: Charlie Strange, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univ of Alabama Birmingham Lung Health Center
name: Mark Dransfield, 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.
citation: Criner GJ, Pinto-Plata V, Strange C, Dransfield M, Gotfried M, Leeds W, McLennan G, Refaely Y, Tewari S, Krasna M, Celli B. Biologic lung volume reduction in advanced upper lobe emphysema: phase 2 results. Am J Respir Crit Care Med. 2009 May 1;179(9):791-8. doi: 10.1164/rccm.200810-1639OC. Epub 2009 Jan 29.