A Phase 1 interventional study of Polymeric Lung Volume Reduction System (PLVR) in Advanced Emphysema, sponsored by Aeris Therapeutics. Completed at 6 sites in Germany. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2011-10-21.
Sponsored by Aeris Therapeutics · Phase 1, Interventional, and Treatment
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.
187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.
This study's enrollment of 25 is below the median of 33 across 128 interventional studies indexed under Pulmonary Emphysema.
Browse Pulmonary Emphysema studies →Aeris Therapeutics is the lead sponsor of 17 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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.
Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)
Change from baseline in RV/TLC ratio at 12 and 24 weeks following treatment
Time frame: 12 and 24 weeks following treatment
Change in Forced Expiratory Volume in 1 Second (FEV1)
o Change from baseline in FEV1 (post bronchodilator) at 12 and 24 weeks following treatment
Time frame: 12 and 24 weeks following treatment
Change in Forced Vital Capacity (FVC)
Change from baseline in FVC (post bronchodilator) at 12 and 24 weeks following treatment
Time frame: 12 and 24 weeks following treatment
Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco)
Change from baseline in DLco at 12 and 24 weeks following treatment
Time frame: 12 and 24 weeks following treatment
Change in Medical Research Council Dyspnea (MRCD) score
Change from baseline in MRCD score at 12 and 24 weeks
Time frame: 12 and 24 weeks following treatment
Change in distance walked in six minutes
Change from baseline at 12 and 248 weeks in 6 Minutes Walk Test (6MWT)
Time frame: 12 and 24 weeks following treatment
Change in St. George's Respiratory Questionnaire (SGRQ) domain score
Change from baseline in disease-specific health related quality of life assessment (SGRQ) at 12 and 24 weeks following treatment
Time frame: 12 and 24 weeks following treatment
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Aeris Therapeutics