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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pulmonary Emphysema	Biological: BLVR Hydrogel	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	5 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Dose Escalation Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Emphysema
Study Start Date :	May 2005
Actual Primary Completion Date :	September 2006
Actual Study Completion Date :	May 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: single; BLVR Treatment	Biological: BLVR Hydrogel; 10 mL BLVR Hydrogel

Outcome Measures

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Primary Outcome Measures :

1. Include: Product-related life-threatening adverse events, permanently disabling complications and deaths [ Time Frame: 1 year post treatment ]
2. FEV1 [ Time Frame: 12 weeks post treatment ]
3. MRC Dyspnea Score [ Time Frame: 12 weeks post treatment ]
4. Six-Minute Walk Test [ Time Frame: 12 week post treatment ]
5. Health-Related Quality of Life [ Time Frame: 12 week post treatment ]

Secondary Outcome Measures :

1. Include: Lung function tests [ Time Frame: 12 week post treatment ]
2. Lung volume measurements [ Time Frame: 12 week post treatment ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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. 

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
First Posted:	September 21, 2005
Last Update Posted:	January 18, 2010
Last Verified:	January 2010

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