NCT00205920

Brief Summary

The purpose of this study is to determine the effective dose of the Aeris BLVR System in patients with advanced emphysema.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
terminated

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, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 18, 2010

Status Verified

January 1, 2010

Enrollment Period

1.3 years

First QC Date

September 13, 2005

Last Update Submit

January 14, 2010

Conditions

Pulmonary Emphysema

Keywords

emphysemapulmonary emphysemaCOPDCOLDchronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (5)

  • Include: Product-related life-threatening adverse events, permanently disabling complications and deaths

    1 year post treatment

  • FEV1

    12 weeks post treatment

  • MRC Dyspnea Score

    12 weeks post treatment

  • Six-Minute Walk Test

    12 week post treatment

  • Health-Related Quality of Life

    12 week post treatment

Secondary Outcomes (2)

  • Include: Lung function tests

    12 week post treatment

  • Lung volume measurements

    12 week post treatment

Study Arms (1)

single

EXPERIMENTAL

BLVR Treatment

Biological: BLVR Hydrogel

Interventions

BLVR HydrogelBIOLOGICAL

10 mL BLVR Hydrogel

single

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of advanced emphysema
  • Age \> 18 years at the time of initial presentation
  • Clinically significant dyspnea (MRC Dyspnea \>/= 2)
  • Laboratory tests within protocol-specified ranges
  • Pulmonary function tests

You may not qualify if:

  • Alpha-1 protease inhibitor deficiency verified by a serum level of \<80mg% or knowledge of PI\*ZZ genotype
  • Tobacco use within 16 weeks of the initial clinic visit
  • Body mass index \< 15 kg/m2 or \> 35 kg/m2
  • Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis
  • Allergy to fish or pork products or sensitivity to tetracycline
  • FEV1 \<20% predicted with DLCO \<20% predicted or homogeneous disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Antonius Ziekenhuis

Nieuwegein, 3430 EM, Netherlands

Location

Related Links

MeSH Terms

Conditions

Pulmonary EmphysemaEmphysemaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • V.A.M. Duurkens, MD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

May 1, 2005

Primary Completion

September 1, 2006

Study Completion

May 1, 2007

Last Updated

January 18, 2010

Record last verified: 2010-01

Locations

NL(1)