US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

Pulmonary Emphysema Clinical Trial

Official title:

Phase 2 Study of the Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435253
• Other study ID #: 01-C06-003
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2007
• Last updated: October 21, 2011
• Start date: February 2007
• Est. completion date: June 2009

Study information

• Verified date: October 2011
• Source: Aeris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Biological:
• BLVR Treatment
BLVR Treatment, 10 mL Hydrogel

Locations

Country	Name	City	State
United States	University of Alabama Birmingham Lung Health Center	Birmingham	Alabama
United States	Caritas St Elizabeth's Med Cen	Boston	Massachusetts
United States	Medical University of South Carolina Hospital	Charleston	South Carolina
United States	Temple University Lung Center	Philadelphia	Pennsylvania
United States	Pulmonary Associates	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Aeris Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2002 Oct 11. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in gas trapping		12 weeks post treatment	No
Primary	SAEs - Safety of treatment and the procedure		2 years	Yes
Secondary	Improvement in vital capacity		12 weeks post treatment	No
Secondary	Improvement in expiratory flow		12 weeks post treatment	No
Secondary	Improvement in inspiratory flow		12 weeks post treatment	No
Secondary	Improvement in dyspnea symptoms (breathlessness)		12 weeks post treatment	No
Secondary	Improvement in exercise capacity		12 weeks post treatment	No
Secondary	Improvement in respiratory quality of life		12 weeks post treatment	No