Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study

NCT00630227 | Completed Phase 2

• 1 other identifier: 01-C07-002
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Homogeneous Emphysema

Keywords

emphysema; chronic obstructive pulmonary disease; lung volume reduction

Outcome Measures

Primary Outcomes (1)

• reduction in gas trapping

  12 weeks post treatment

Secondary Outcomes (6)

• improvement in exercise capacity

  12 weeks post treatment

• improvement in expiratory flow

  12 weeks post treatment

• improvement in vital capacity

  12 weeks post treatment

• improvement in dyspnea sysmptoms

  12 weeks post treatment

• improvemnet in respiratory quality of life

  12 weeks post treatment

Study Arms (1)

Single

EXPERIMENTAL

all patients are treated with the experimental therapy

Biological: Biologic Lung Volume Reduction

Interventions

Biologic Lung Volume Reduction BIOLOGICAL

20 mL Hydrogel

Single

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Minute Walk Distance \>/= 150 m

You may not qualify if:

• 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

Sponsors & Collaborators

• Aeris Therapeutics: lead

Study Sites (8)

University of Alabama

Birmingham, Alabama, 35249, United States

Location

Pulmonary Associates

Phoenix, Arizona, 85006, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Veritas Clinical Specialties

Topeka, Kansas, 66606, United States

Location

St Josephs Medical Center

Towson, Maryland, 21204, United States

Location

Akron Medical Center

Akron, Ohio, 44302, United States

Location

Cleveland Clinic Foundation, Pulmonary Allergy & Critical Care Medicine

Cleveland, Ohio, 44195, United States

Location

Temple University Lung Center

Philadelphia, Pennsylvania, 19140, United States

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: 12406835 BACKGROUND

• 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: 17426216 BACKGROUND

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark Gotfried, MD

  Pulmonary Associates, Phoenix, AZ

  PRINCIPAL INVESTIGATOR

• Mark Dransfield, MD

  University of Alabama, Birmingham, AL

  PRINCIPAL INVESTIGATOR

• Gerard Criner, MD

  Temple University Lung Center, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

• William Leeds, DO

  Veritas Clinical Specialties, Topeka, KS

  PRINCIPAL INVESTIGATOR

• Mark Krasna, MD

  St Josephs Medical Center, Towson, MD

  PRINCIPAL INVESTIGATOR

• Thomas Gildea, MD

  Cleveland Clinic, Cleveland, OH

  PRINCIPAL INVESTIGATOR

• Sanjiv Tewari, MD

  Akron Medical Center, Akron, OH

  PRINCIPAL INVESTIGATOR

• Geoffrey McLennan, MD

  University of Iowa Hospitals & Clinics, Iowa City, IA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 6, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 24, 2011

Record last verified: 2011-10

Locations

US (8)