Clinical trial NCT00884962: A Dose Ranging Study of the Aeris Polymeric Lung Volume Reduction (PLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Emphysema
Keywords: emphysema
aeris
PLVR
BLVR
germany
treatment
device
breathing
Lead sponsor: Aeris Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-04-21
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)
timeFrame: 12 and 24 weeks following treatment
Secondary outcomes:
measure: Change in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: 12 and 24 weeks following treatment
measure: Change in Forced Vital Capacity (FVC)
timeFrame: 12 and 24 weeks following treatment
measure: Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco)
timeFrame: 12 and 24 weeks following treatment
measure: Change in Medical Research Council Dyspnea (MRCD) score
timeFrame: 12 and 24 weeks following treatment
measure: Change in distance walked in six minutes
timeFrame: 12 and 24 weeks following treatment
measure: Change in St. George's Respiratory Questionnaire (SGRQ) domain score
timeFrame: 12 and 24 weeks following treatment
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Chefarzt Klinik für Pneumologie
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Medizinische Klinik Infektiologie und Pulmologie
city: Grosshansdorf
country: Germany
facility: Pneumologisches Forschungsinstitut
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Munich
country: Germany
facility: Medizinische Klinik und Poliklinik Klinikum Großhadern
Study officials:
References:
citation: Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.
citation: Magnussen H, Kramer MR, Kirsten AM, Marquette C, Valipour A, Stanzel F, Bonnet R, Behr J, Fruchter O, Refaely Y, Eberhardt R, Herth FJ. Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. Thorax. 2012 Apr;67(4):302-8. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28.