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

NCT00205907 | Terminated Phase 1

• 1 other identifier: C04-003
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.

Conditions

Pulmonary Emphysema

Keywords

BLVR; emphysema; COPD; COLD; chronic obstructive pulmonary disease; pulmonary emphysema

Outcome Measures

Primary Outcomes (5)

• Product-related life-threatening adverse events, permanently disabling complications and deaths

  1 year post treatment

• FEV1

  12 weeks post treatment

• MRC Dyspnea Score

  12 weeks post treatment

• Six-Minute Walk Test

  12 weeks post treatment

• Health-Related Quality of Life

  12 weeks post treatment

Secondary Outcomes (2)

• Lung function tests

  12 weeks post treatment

• Lung volume measures

  12 weeks post treatment

Study Arms (1)

single

EXPERIMENTAL

BLVR treatment

Biological: BLVR Hydrogel

Interventions

BLVR Hydrogel BIOLOGICAL

10 mL BLVR Hydrogel

single

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aeris Therapeutics: lead

Study Sites (1)

Chaim Sheba (Tel Hashomer) Medical Center

Ramat Gan, 52621, Israel

Location

Related Links

• 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.

MeSH Terms

Conditions

Pulmonary Emphysema; Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Issahar Ben-Dov, MD

  The Chaim Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: April 1, 2007
• Last Updated: March 6, 2008

Record last verified: 2008-02

Locations

IL (1)