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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
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
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
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