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

Phase 1

Completed

• Conditions: Advanced Emphysema

• Registration Number: NCT00884962
• Lead Sponsor: Aeris Therapeutics

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, 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-20
• Last Update Posted: 2011-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)	12 and 24 weeks following treatment	Change from baseline in RV/TLC ratio at 12 and 24 weeks following treatment

Secondary Outcome Measures

Name	Time	Method
Change in Forced Expiratory Volume in 1 Second (FEV1)	12 and 24 weeks following treatment	o Change from baseline in FEV1 (post bronchodilator) at 12 and 24 weeks following treatment
Change in Forced Vital Capacity (FVC)	12 and 24 weeks following treatment	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)	12 and 24 weeks following treatment	Change from baseline in DLco at 12 and 24 weeks following treatment
Change in Medical Research Council Dyspnea (MRCD) score	12 and 24 weeks following treatment	Change from baseline in MRCD score at 12 and 24 weeks
Change in distance walked in six minutes	12 and 24 weeks following treatment	Change from baseline at 12 and 248 weeks in 6 Minutes Walk Test (6MWT)
Change in St. George's Respiratory Questionnaire (SGRQ) domain score	12 and 24 weeks following treatment	Change from baseline in disease-specific health related quality of life assessment (SGRQ) at 12 and 24 weeks following treatment

Trial Locations

Locations (6)

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