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US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

NCT ID: NCT00435253

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-06-30

Brief Summary

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Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.

Detailed Description

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Prospective, open-label, non-controlled, multi-center Phase 2 Study evaluating the efficacy and safety of the 10 mL BLVR System in patients with advanced upper lobe predominant emphysema. Twenty patients will be divided into 2 groups of 10 patients each and treated under conscious sedation at a total of 8 subsegments. Group 1 will be treated in 4 subsegments in 1 lung and have a second treatment of 4 subsegments in the other lung 6 to 12 weeks later. Group 2 will receive treatment at 8 subsegments (4 in each lung) during a single treatment session if possible; if not completed in 1 session the remaining subsegments will be treated 6 to 12 weeks later. Patients will be followed 96 weeks after completion of the final BLVR treatment. All patients will receive standard medical therapy in addition to BLVR treatment.

Conditions

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Pulmonary Emphysema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BLVR Treatment

BLVR Treatment

Group Type EXPERIMENTAL

BLVR Treatment

Intervention Type BIOLOGICAL

BLVR Treatment, 10 mL Hydrogel

Interventions

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BLVR Treatment

BLVR Treatment, 10 mL Hydrogel

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of advanced upper lobe predominant emphysema
* age \>/= 40 years
* clinically significant dyspnea
* failure of standard medical therapy to relieve symptoms (inhaled beta agonist and inhaled anticholinergic)
* pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 \< 45% predicted and experiencing \< 30% or 300 mL improvement using bronchodilator; TLC \> 110% predicted; RV \> 150% predicted)
* 6 Minute Walk Distance \>/= 150 m

Exclusion Criteria

* alpha-1 protease inhibitor deficiency
* homogeneous disease
* 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, endobronchial valve placement, airway stent placement or pleurodesis
* comorbid condition that could adversely influence outcomes
* inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
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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Victor Pinto-Plata, MD

Role: PRINCIPAL_INVESTIGATOR

Steward St. Elizabeth's Medical Center of Boston, Inc.

Gerard Criner, MD

Role: PRINCIPAL_INVESTIGATOR

Temple University Lung Center

Mark Gotfried, MD

Role: PRINCIPAL_INVESTIGATOR

Pulmonary Associates

Charlie Strange, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Univ South Carolina Hospital

Mark Dransfield, MD

Role: PRINCIPAL_INVESTIGATOR

Univ of Alabama Birmingham Lung Health Center

Locations

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University of Alabama Birmingham Lung Health Center

Birmingham, Alabama, United States

Site Status

Pulmonary Associates

Phoenix, Arizona, United States

Site Status

Caritas St Elizabeth's Med Cen

Boston, Massachusetts, United States

Site Status

Temple University Lung Center

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina Hospital

Charleston, South Carolina, 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)

Criner GJ, Pinto-Plata V, Strange C, Dransfield M, Gotfried M, Leeds W, McLennan G, Refaely Y, Tewari S, Krasna M, Celli B. Biologic lung volume reduction in advanced upper lobe emphysema: phase 2 results. Am J Respir Crit Care Med. 2009 May 1;179(9):791-8. doi: 10.1164/rccm.200810-1639OC. Epub 2009 Jan 29.

Reference Type DERIVED
PMID: 19179484 (View on PubMed)

Other Identifiers

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01-C06-003

Identifier Type: -

Identifier Source: org_study_id