A Dose Ranging Study of the Aeris Polymeric Lung Volume Reduction (PLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema

This study is currently recruiting participants.

Verified by Aeris Therapeutics, April 2009

First Received: April 20, 2009 No Changes Posted

Sponsored by:	Aeris Therapeutics
Information provided by:	Aeris Therapeutics
ClinicalTrials.gov Identifier:	NCT00884962

Purpose

This is a multi-center, open-label, non-controlled Pilot Study. Approximately 24 patients will be assigned to one of 3 treatment groups (8 patients each group). Patients in each group will receive 2, 4, and 6 (3 followed by a retreatment of 3) subsegmental treatments, respectively. All patients will receive treatment in a single lung under conscious sedation or general anesthesia. Patients will be followed for 24 weeks after completion of PLVR treatment(s). Upon completion of 12-week follow-up, all safety and efficacy data will be analyzed to determine an effective treatment dose. Thereafter, Group 1 patients may elect to be retreated at additional sites so that their total dose received is consistent with the effective dose. All study patients will receive standard medical therapy in addition to PLVR.

Condition	Intervention	Phase
Advanced Emphysema	Device: Polymeric Lung Volume Reduction System (PLVR)	Phase I

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Emphysema

U.S. FDA Resources

Further study details as provided by Aeris Therapeutics:

Study Start Date:	December 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PLVR: Experimental	Device: Polymeric Lung Volume Reduction System (PLVR)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have a diagnosis of advanced upper lobe predominant (ULP) emphysema or advanced disease in the superior lower lobes as defined by FEV1/FVC <70 % predicted, FEV1 of < 50% predicted, TLC > 100% of predicted, and RV > 135% predicted.
Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
Patients must be > 40 years of age, have symptoms despite medical therapy, and have none of the pre-specified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884962

Contacts

Contact: Janine McDermott

janine.mcdermott@aerist.com

Locations

Germany
Thoraxklinik Heidelberg	Recruiting
Heidelberg, Germany
Contact: Ralf Eberhardt 06221-396-1204 Ralf.Eberhardt@thoraxklinik-heidelberg.de
Principal Investigator: Felix Herth, Prof.
Pneumologisches Forschungsinstitut	Recruiting
Grosshansdorf, Germany
Contact: Anne Kirsten 49 4102 8881-130 a.kirsten@pulmoresearch.de
Principal Investigator: Helgo Magnussen, Prof.
Lungenklinik Hemer	Recruiting
Hemer, Germany
Contact: Tanja Fries 02372 - 908 2167 Tanja.Fries@lkhemer.de
Principal Investigator: Franz Stanzel, Prof.
Charité Universitätsmedizin Medizinische Klinik Infektiologie und Pulmologie	Recruiting
Berlin, Germany
Contact: Bernd Schmidt 49 30-450 565 022 b.schmidt@charite.de
Principal Investigator: Christian Witt, Prof.
Medizinische Klinik und Poliklinik Klinikum Großhadern	Recruiting
Munich, Germany
Contact: Mirjam Landmesser Mirjam.Landmesser@med.uni-muenchen.de
Principal Investigator: Jürgen Behr, Prof.
Chefarzt Klinik für Pneumologie	Recruiting
Bad Berka, Germany
Contact: Yvonne Lautenschlaeger y.lautenschlaeger.aed@zentralklinik-bad-berka.de
Principal Investigator: Reiner Bonnet, Prof.

Sponsors and Collaborators

Aeris Therapeutics

More Information

No publications provided

Study ID Numbers:	03-C08-003PLV
Study First Received:	April 20, 2009
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00884962 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Aeris Therapeutics:

emphysema
aeris
PLVR
BLVR

germany
treatment
device
breathing

Study placed in the following topic categories:

Pulmonary Emphysema
Emphysema
Lung Diseases, Obstructive

Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Pulmonary Emphysema
Emphysema
Lung Diseases, Obstructive
Pathologic Processes

Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on August 24, 2009