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

Primary Purpose

Advanced Emphysema

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Polymeric Lung Volume Reduction System (PLVR)

About this trial

This is an interventional treatment trial for Advanced Emphysema focused on measuring emphysema, aeris, PLVR, BLVR, germany, treatment, device, breathing

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chefarzt Klinik für Pneumologie
Charité Universitätsmedizin Medizinische Klinik Infektiologie und Pulmologie
Pneumologisches Forschungsinstitut
Thoraxklinik Heidelberg
Lungenklinik Hemer
Medizinische Klinik und Poliklinik Klinikum Großhadern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PLVR

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Forced Expiratory Volume in 1 Second (FEV1)

o Change from baseline in FEV1 (post bronchodilator) at 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

Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco)

Change from baseline in DLco at 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

Change in distance walked in six minutes

Change from baseline at 12 and 248 weeks in 6 Minutes Walk Test (6MWT)

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

Full Information

NCT ID

NCT00884962

First Posted

April 20, 2009

Last Updated

October 20, 2011

Sponsor

Aeris Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT00884962

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aeris Therapeutics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Emphysema

Keywords

emphysema, aeris, PLVR, BLVR, germany, treatment, device, breathing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PLVR

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Polymeric Lung Volume Reduction System (PLVR)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)

Description

Change from baseline in RV/TLC ratio at 12 and 24 weeks following treatment

Time Frame

12 and 24 weeks following treatment

Secondary Outcome Measure Information:

Title

Change in Forced Expiratory Volume in 1 Second (FEV1)

Description

o Change from baseline in FEV1 (post bronchodilator) at 12 and 24 weeks following treatment

Time Frame

12 and 24 weeks following treatment

Title

Change in Forced Vital Capacity (FVC)

Description

Change from baseline in FVC (post bronchodilator) at 12 and 24 weeks following treatment

Time Frame

12 and 24 weeks following treatment

Title

Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco)

Description

Change from baseline in DLco at 12 and 24 weeks following treatment

Time Frame

12 and 24 weeks following treatment

Title

Change in Medical Research Council Dyspnea (MRCD) score

Description

Change from baseline in MRCD score at 12 and 24 weeks

Time Frame

12 and 24 weeks following treatment

Title

Change in distance walked in six minutes

Description

Change from baseline at 12 and 248 weeks in 6 Minutes Walk Test (6MWT)

Time Frame

12 and 24 weeks following treatment

Title

Change in St. George's Respiratory Questionnaire (SGRQ) domain score

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Chefarzt Klinik für Pneumologie

City

Bad Berka

Country

Germany

Facility Name

Charité Universitätsmedizin Medizinische Klinik Infektiologie und Pulmologie

City

Berlin

Country

Germany

Facility Name

Pneumologisches Forschungsinstitut

City

Grosshansdorf

Country

Germany

Facility Name

Thoraxklinik Heidelberg

City

Heidelberg

Country

Germany

Facility Name

Lungenklinik Hemer

City

Hemer

Country

Germany

Facility Name

Medizinische Klinik und Poliklinik Klinikum Großhadern

City

Munich

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

33590989

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.

Results Reference

derived

PubMed Identifier

22374920

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.

Results Reference

derived

Learn more about this trial

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

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