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Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study

NCT ID: NCT00630227

Last Updated: 2011-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-12-31

Brief Summary

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The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also eligible for participation.

Detailed Description

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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 (LVRS) involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. LVRS, 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 or in the case of homogeneous disease, areas that are less active as shown by the extent of regional blood flow. 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 treated areas of the lung. This provides room within the chest to allow the remaining 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 (upper lobe predominant) 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.

Conditions

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Homogeneous Emphysema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single

all patients are treated with the experimental therapy

Group Type EXPERIMENTAL

Biologic Lung Volume Reduction

Intervention Type BIOLOGICAL

20 mL Hydrogel

Interventions

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Biologic Lung Volume Reduction

20 mL Hydrogel

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of advanced homogeneous or upper lobe predominant emphysema demonstrated by CT scan
* age \>/= 40 years
* clinically significant dyspnea
* failure of standard medical therapy (typically inhaled beta agonist \& inhaled anticholinergic) to relieve symptoms
* 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

* tobacco use within 4 months of initial visit or during study
* 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
* inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
* history of renal infarction or renal failure lung perfusion scan indicating \> 20% of blood flow to either upper lung field or 30% total to both upper lung fields if homogeneous emphysema
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aeris Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Gotfried, MD

Role: PRINCIPAL_INVESTIGATOR

Pulmonary Associates, Phoenix, AZ

Mark Dransfield, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama, Birmingham, AL

Gerard Criner, MD

Role: PRINCIPAL_INVESTIGATOR

Temple University Lung Center, Philadelphia, PA

William Leeds, DO

Role: PRINCIPAL_INVESTIGATOR

Veritas Clinical Specialties, Topeka, KS

Mark Krasna, MD

Role: PRINCIPAL_INVESTIGATOR

St Josephs Medical Center, Towson, MD

Thomas Gildea, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Cleveland, OH

Sanjiv Tewari, MD

Role: PRINCIPAL_INVESTIGATOR

Akron Medical Center, Akron, OH

Geoffrey McLennan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa Hospitals & Clinics, Iowa City, IA

Locations

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University of Alabama

Birmingham, Alabama, United States

Site Status

Pulmonary Associates

Phoenix, Arizona, United States

Site Status

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

Site Status

Veritas Clinical Specialties

Topeka, Kansas, United States

Site Status

St Josephs Medical Center

Towson, Maryland, United States

Site Status

Akron Medical Center

Akron, Ohio, United States

Site Status

Cleveland Clinic Foundation, Pulmonary Allergy & Critical Care Medicine

Cleveland, Ohio, United States

Site Status

Temple University Lung Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12406835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17426216 (View on PubMed)

Other Identifiers

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01-C07-002

Identifier Type: -

Identifier Source: org_study_id