Status:
COMPLETED
A Dose Ranging Study of the Aeris Polymeric Lung Volume Reduction (PLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
Lead Sponsor:
Aeris Therapeutics
Conditions:
Advanced Emphysema
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief Summary
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, ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00884962
Start Date
December 1 2008
End Date
May 1 2010
Last Update
October 21 2011
Active Locations (6)
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1
Chefarzt Klinik für Pneumologie
Bad Berka, Germany
2
Charité Universitätsmedizin Medizinische Klinik Infektiologie und Pulmologie
Berlin, Germany
3
Pneumologisches Forschungsinstitut
Großhansdorf, Germany
4
Thoraxklinik Heidelberg
Heidelberg, Germany