Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation - Full Text View

Purpose

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

Condition	Intervention	Phase
Pulmonary Emphysema	Biological: BLVR Hydrogel	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Dose Escalation Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Emphysema

Resource links provided by NLM:

MedlinePlus related topics: Emphysema

U.S. FDA Resources

Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:

Include: Product-related life-threatening adverse events, permanently disabling complications and deaths [ Time Frame: 1 year post treatment ] [ Designated as safety issue: Yes ]
FEV1 [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
MRC Dyspnea Score [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
Six-Minute Walk Test [ Time Frame: 12 week post treatment ] [ Designated as safety issue: No ]
Health-Related Quality of Life [ Time Frame: 12 week post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Include: Lung function tests [ Time Frame: 12 week post treatment ] [ Designated as safety issue: No ]
Lung volume measurements [ Time Frame: 12 week post treatment ] [ Designated as safety issue: No ]


Enrollment:	5
Study Start Date:	May 2005
Study Completion Date:	May 2007
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: single BLVR Treatment	Biological: BLVR Hydrogel 10 mL BLVR Hydrogel

Detailed Description:

Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.

Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Bronchoscopic Lung Volume Reduction (BLVR) Hydrogel System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. This study will evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria include:

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

Exclusion Criteria include:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205920

Locations


Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430 EM

Sponsors and Collaborators

Aeris Therapeutics

Investigators


Principal Investigator:	V.A.M. Duurkens, MD	St. Antonius Ziekenhuis

More Information

Additional Information:

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. Epub 2002 Oct 11. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site


Responsible Party:	Edward P Ingenito, MD, PhD, Medical Director & CSO, Aeris Therapeutics Inc
ClinicalTrials.gov Identifier:	NCT00205920 History of Changes
Other Study ID Numbers:	C04-012
Study First Received:	September 13, 2005
Last Updated:	January 14, 2010
Health Authority:	Netherlands: Independent Ethics Committee

Keywords provided by Aeris Therapeutics:


emphysema pulmonary emphysema COPD COLD chronic obstructive pulmonary disease

Additional relevant MeSH terms:


Emphysema Pulmonary Emphysema Pathologic Processes Pulmonary Disease, Chronic Obstructive	Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 23, 2016