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

Primary Purpose

Pulmonary Emphysema

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BLVR Treatment

About this trial

This is an interventional treatment trial for Pulmonary Emphysema focused on measuring emphysema, COPD, lung volume reduction, NETT, BLVR, biologic lung volume reduction, bronchoscopic lung volume reduction

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of Alabama Birmingham Lung Health Center
Pulmonary Associates
Caritas St Elizabeth's Med Cen
Temple University Lung Center
Medical University of South Carolina Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BLVR Treatment

Arm Description

BLVR Treatment

Outcomes

Primary Outcome Measures

Reduction in gas trapping

SAEs - Safety of treatment and the procedure

Secondary Outcome Measures

Improvement in vital capacity

Improvement in expiratory flow

Improvement in inspiratory flow

Improvement in dyspnea symptoms (breathlessness)

Improvement in exercise capacity

Improvement in respiratory quality of life

Full Information

NCT ID

NCT00435253

First Posted

February 7, 2007

Last Updated

October 21, 2011

Sponsor

Aeris Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00435253

Brief Title

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

Official Title

Phase 2 Study of the Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aeris Therapeutics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Emphysema

Keywords

emphysema, COPD, lung volume reduction, NETT, BLVR, biologic lung volume reduction, bronchoscopic lung volume reduction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BLVR Treatment

Arm Type

Experimental

Arm Description

BLVR Treatment

Intervention Type

Biological

Intervention Name(s)

BLVR Treatment

Intervention Description

BLVR Treatment, 10 mL Hydrogel

Primary Outcome Measure Information:

Title

Reduction in gas trapping

Time Frame

12 weeks post treatment

Title

SAEs - Safety of treatment and the procedure

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Improvement in vital capacity

Time Frame

12 weeks post treatment

Title

Improvement in expiratory flow

Time Frame

12 weeks post treatment

Title

Improvement in inspiratory flow

Time Frame

12 weeks post treatment

Title

Improvement in dyspnea symptoms (breathlessness)

Time Frame

12 weeks post treatment

Title

Improvement in exercise capacity

Time Frame

12 weeks post treatment

Title

Improvement in respiratory quality of life

Time Frame

12 weeks post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials: