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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT00884962
First received: April 20, 2009
Last updated: October 20, 2011
Last verified: October 2011
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline in RV/TLC ratio at 12 and 24 weeks following treatment


Secondary Outcome Measures:
  • Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
    o Change from baseline in FEV1 (post bronchodilator) at 12 and 24 weeks following treatment

  • Change in Forced Vital Capacity (FVC) [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline in FVC (post bronchodilator) at 12 and 24 weeks following treatment

  • Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline in DLco at 12 and 24 weeks following treatment

  • Change in Medical Research Council Dyspnea (MRCD) score [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline in MRCD score at 12 and 24 weeks

  • Change in distance walked in six minutes [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 12 and 248 weeks in 6 Minutes Walk Test (6MWT)

  • Change in St. George's Respiratory Questionnaire (SGRQ) domain score [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline in disease-specific health related quality of life assessment (SGRQ) at 12 and 24 weeks following treatment


Enrollment: 25
Study Start Date: December 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PLVR Device: Polymeric Lung Volume Reduction System (PLVR)
20ml (each) of polymer will be injected into 2, 3 or 4 subsegments during the first treatment. Eligible patients may have 20ml (each) of polymer will be injected into 2 or 3 subsegments during the second treatment.

  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

Locations
Germany
Chefarzt Klinik für Pneumologie
Bad Berka, Germany
Charité Universitätsmedizin Medizinische Klinik Infektiologie und Pulmologie
Berlin, Germany
Pneumologisches Forschungsinstitut
Grosshansdorf, Germany
Thoraxklinik Heidelberg
Heidelberg, Germany
Lungenklinik Hemer
Hemer, Germany
Medizinische Klinik und Poliklinik Klinikum Großhadern
Munich, Germany
Sponsors and Collaborators
Aeris Therapeutics
  More Information

No publications provided by Aeris Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT00884962     History of Changes
Other Study ID Numbers: 03-C08-003PLV
Study First Received: April 20, 2009
Last Updated: October 20, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Aeris Therapeutics:
emphysema
aeris
PLVR
BLVR
 germany
treatment
device
breathing

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013