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Israeli 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation

Primary Purpose

Pulmonary Emphysema

Status
Terminated
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
BLVR Hydrogel
Sponsored by
Aeris Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Emphysema focused on measuring BLVR, emphysema, COPD, COLD, chronic obstructive pulmonary disease, pulmonary emphysema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria include: Clinical diagnosis of advanced heterogeneous emphysema Age > 18 years at the time of initial presentation Clinically significant dyspnea (MRC Dyspnea >/= 2) Failure of standard medical therapy to provide relief of symptoms BUN, creatinine, ALT, AST, alkaline phosphatase, WBC, hematocrit, platelet count, PT and PTT within normal limits Pulmonary function tests Exclusion Criteria: Alpha-1 protease inhibitor deficiency verified by a serum level of < 80 mg% or knowledge of PI*ZZ genotype Body mass index < 15 kg/m2 or > 35 kg/m2 Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis Tobacco use within 16 weeks of the initial clinic visit Allergy to fish or pork products or sensitivity to tetracycline FEV1 <20% with DLCO <20% or homogeneous disease

Sites / Locations

  • Chaim Sheba (Tel Hashomer) Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single

Arm Description

BLVR treatment

Outcomes

Primary Outcome Measures

Product-related life-threatening adverse events, permanently disabling complications and deaths
FEV1
MRC Dyspnea Score
Six-Minute Walk Test
Health-Related Quality of Life

Secondary Outcome Measures

Lung function tests
Lung volume measures

Full Information

First Posted
September 13, 2005
Last Updated
February 27, 2008
Sponsor
Aeris Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00205907
Brief Title
Israeli 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation
Official Title
Phase 1/Phase 2 Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Emphysema
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Terminated
Why Stopped
Change in Formulation
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aeris Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.
Detailed Description
Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come. Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Bronchoscopic Lung Volume Reduction (BLVR) Hydrogel System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. The current study will evaluate the safety and efficacy of this procedure in patients with advanced emphysema.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Emphysema
Keywords
BLVR, emphysema, COPD, COLD, chronic obstructive pulmonary disease, pulmonary emphysema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single
Arm Type
Experimental
Arm Description
BLVR treatment
Intervention Type
Biological
Intervention Name(s)
BLVR Hydrogel
Intervention Description
10 mL BLVR Hydrogel
Primary Outcome Measure Information:
Title
Product-related life-threatening adverse events, permanently disabling complications and deaths
Time Frame
1 year post treatment
Title
FEV1
Time Frame
12 weeks post treatment
Title
MRC Dyspnea Score
Time Frame
12 weeks post treatment
Title
Six-Minute Walk Test
Time Frame
12 weeks post treatment
Title
Health-Related Quality of Life
Time Frame
12 weeks post treatment
Secondary Outcome Measure Information:
Title
Lung function tests
Time Frame
12 weeks post treatment
Title
Lung volume measures
Time Frame
12 weeks post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria include: Clinical diagnosis of advanced heterogeneous emphysema Age > 18 years at the time of initial presentation Clinically significant dyspnea (MRC Dyspnea >/= 2) Failure of standard medical therapy to provide relief of symptoms BUN, creatinine, ALT, AST, alkaline phosphatase, WBC, hematocrit, platelet count, PT and PTT within normal limits Pulmonary function tests Exclusion Criteria: Alpha-1 protease inhibitor deficiency verified by a serum level of < 80 mg% or knowledge of PI*ZZ genotype Body mass index < 15 kg/m2 or > 35 kg/m2 Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis Tobacco use within 16 weeks of the initial clinic visit Allergy to fish or pork products or sensitivity to tetracycline FEV1 <20% with DLCO <20% or homogeneous disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Issahar Ben-Dov, MD
Organizational Affiliation
The Chaim Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaim Sheba (Tel Hashomer) Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi
Description
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.

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Israeli 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation

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