NCT00517998

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 18, 2010

Status Verified

January 1, 2010

Enrollment Period

1.8 years

First QC Date

August 15, 2007

Last Update Submit

January 14, 2010

Conditions

Pulmonary EmphysemaChronic Obstructive Pulmonary Disease

Keywords

Lung volume reductionBronchoscopyEmphysemaCOPDNETTLung diseaseCOLDBLVR

Outcome Measures

Primary Outcomes (1)

  • SAEs - Safety of treatment and the procedure

    1 year

Secondary Outcomes (6)

  • Reduction in gas trapping

    12 weeks

  • Improvement in exercise capacity

    12 weeks

  • Improvement in lung function (vital capacity)

    12 weeks

  • Improvement in lung function (expiratory flow)

    12 weeks

  • Improvement on dyspnea symptoms

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Group1

EXPERIMENTAL

Treatment will be administered in two sessions.

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

Group2

EXPERIMENTAL

Treatment will be administered in a single session.

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

Interventions

Biologic Lung Volume Reduction (BLVR) - 10 mL HydrogelDRUG

10 mL Hydrogel

Group1Group2

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Minute Walk Distance \>/= 150 m

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petach Tivka, 49110, Israel

Location

Related 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. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11.

    PMID: 12406835BACKGROUND

  • 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.

    PMID: 17426216BACKGROUND

MeSH Terms

Conditions

Pulmonary EmphysemaPulmonary Disease, Chronic ObstructiveEmphysemaLung Diseases

Interventions

Hydrogels

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GelsColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Yael Refaely, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 15, 2007

First Posted

August 17, 2007

Study Start

May 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 18, 2010

Record last verified: 2010-01

Locations

IL(1)