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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00517998
Other study ID # 01-C06-002
Secondary ID
Status Completed
Phase Phase 1
First received August 15, 2007
Last updated January 14, 2010
Start date May 2007
Est. completion date March 2009

Study information

Verified date January 2010
Source Aeris Therapeutics
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema refractory to medical therapy.


Description:

Background:

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 involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. This procedure, 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. 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 diseased areas of the lung. This provides room within the chest to allow the remaining healthier 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- clinical diagnosis of advanced emphysema

- age >/= 40 years

- clinically significant dyspnea

- failure of standard medical therapy to relieve symptoms (inhaled beta agonist & inhaled anticholinergic)

- 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:

- alpha-1 protease inhibitor deficiency

- 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, endotracheal valve placement, airway stent placement or pleurodesis

- comorbid condition that could adversely influence outcomes

- significant comorbidity

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel
10 mL Hydrogel

Locations

Country Name City State
Israel Rabin Medical Center Petach Tivka

Sponsors (1)

Lead Sponsor Collaborator
Aeris Therapeutics

Country where clinical trial is conducted

Israel, 

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 SAEs - Safety of treatment and the procedure 1 year Yes
Secondary Reduction in gas trapping 12 weeks No
Secondary Improvement in exercise capacity 12 weeks No
Secondary Improvement in lung function (vital capacity) 12 weeks No
Secondary Improvement in lung function (expiratory flow) 12 weeks No
Secondary Improvement on dyspnea symptoms 12 weeks No
Secondary Improvement in quality of life 12 weeks No
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