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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00884962
Other study ID # 03-C08-003PLV
Secondary ID
Status Completed
Phase Phase 1
First received April 20, 2009
Last updated October 20, 2011
Start date December 2008
Est. completion date May 2010

Study information

Verified date October 2011
Source Aeris Therapeutics
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Germany 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

Sponsors (1)

Lead Sponsor Collaborator
Aeris Therapeutics

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 and 24 weeks following treatment No
Secondary Change in Forced Expiratory Volume in 1 Second (FEV1) o Change from baseline in FEV1 (post bronchodilator) at 12 and 24 weeks following treatment 12 and 24 weeks following treatment No
Secondary Change in Forced Vital Capacity (FVC) Change from baseline in FVC (post bronchodilator) at 12 and 24 weeks following treatment 12 and 24 weeks following treatment No
Secondary Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) Change from baseline in DLco at 12 and 24 weeks following treatment 12 and 24 weeks following treatment No
Secondary Change in Medical Research Council Dyspnea (MRCD) score Change from baseline in MRCD score at 12 and 24 weeks 12 and 24 weeks following treatment No
Secondary Change in distance walked in six minutes Change from baseline at 12 and 248 weeks in 6 Minutes Walk Test (6MWT) 12 and 24 weeks following treatment No
Secondary 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 12 and 24 weeks following treatment No