Emphysematous Lung Sealant Therapy in Homogeneous Emphysema

Post Market Investigator Sponsored Study of Emphysematous Lung Sealant Therapy in Homogeneous Emphysema Using a Modified Treatment Strategy

This study will test that hypothesis that endoscopic lung volume reduction therapy performed using emphysematous lung sealant treatment can be improved using smaller doses delivered to more a larger number of treatment sites.

Study Overview

• Status: Unknown
• Conditions: Patients With Advanced Homogeneous Emphysema
• Intervention / Treatment: Procedure: ELVR Procedure

Detailed Description

This is an investigational, single arm, physician-sponsored study that will be conducted at Rabin Medical Center under the direction of Professor Mordechai Kramer. Patients will receive AeriSeal System therapy using a new treatment algorithm to deliver approved foam sealant components at doses at or below those previously shown to be safe and effective during prior studies. Investigational aspects of this study involve only the method of administration of material, not the material itself. The specific modifications to the treatment method proposed in this study include: 1) lowering the dose per subsegment of AeriSeal System Foam Sealant to 10 mL from the approved 20 mL dose; 2) administering the subsegmental doses at more anatomic locations with the goal of improving distribution of material and achieving more effective lung volume reduction; 3) eliminating the administration of air through the instrument channel of the bronchoscope following Foam Sealant delivery to simply and shorten the procedure, improving safety.

The study is designed to treat 8 patients. The first 4 patients will receive treatment with 10 mL of AeriSeal System Foam Sealant administered at 6 subsegments, 3 in each upper lobe (a dose of 60 mL of AeriSeal Foam Sealant). This group will be followed until all 4 have completed 1 month (28 day) follow-up. A safety review of the data will then be conducted prior to initiating treatment in the next group of 4 patients. This review will include an assessment of adverse events and physiological responses.

Assuming no emergent safety issues are identified, the next group of 4 patients will receive treatment with 10 mL of AeriSeal System Foam Sealant administered at 8 subsegments, 3 in each upper lobe, one in the upper-most portion of the right middle lobe, one in the upper-most portion of the lingual (a dose of 80 mL of AeriSeal Foam Sealant).

All patients will be followed for 24 weeks after completion of therapy and receive standard medical treatment in addition to treatment with the AeriSeal System.

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mordechai R Kramer, MD; Email: kremerm@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel, 49100
    • Rabin Medical Center
    • Principal Investigator: Mordechai R Kramer, MD
    • Contact: Mordechai R Kramer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients must have a diagnosis of GOLD Stage III/IV homogeneous emphysema
2. FEV1/FVC <70 % predicted, FEV1 of < 50% predicted, TLC > 100% of predicted, and RV > 150% predicted.
3. chest CT scan showing evidence of tissue destruction indicative of homogeneous (uniformly distributed) emphysema.
4. Patients must also have ≤ 15% perfusion in both upper lobes on a quantitative lung perfusion scan indicating bilateral target sites for therapy.
5. Patients must be > 40 years of age.

Exclusion Criteria:

1. Alpha-1 antitrypsin deficient patients (i.e. those with serum levels < 80 mg/dL, or < 11 µmol/L or 57 mg/dL).
2. patients who are pregnant or breast feeding.
3. patients who are smoking.
4. patients using other investigational medications will be excluded.
5. 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.
6. have no significant co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.
7. Specifically, patients should not have a history of prior major thoracic surgery, HIV infection, clinically significant asthma, bronchiectasis, pulmonary hypertension or coronary heart disease.
8. Patients must also not be dependent on medications that could increase the risk of undergoing treatment or adversely effect the chance of recovering from treatment (i.e. high dose steroids, immunosuppressive agents, or anticoagulants)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ELVR Procedure; A single subsegmental AeriSeal System treatment consists of the administration of 10 mL Foam Sealant administered through a standard fiberoptic bronchoscope via an administration syringe and bronchoscopic catheter into the target area of damaged lung	Procedure: ELVR Procedure; Lung Volume Reduction Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall safety assessment	Overall assessment of safety based on review; Clinical and laboratory results:Serious Adverse Events (SAEs)Serious Adverse Device Effects (SADEs)Unanticipated Serious Adverse Device Effects (USADEs)Physical ExaminationsVital signsSerum chemistry and hematology.; Changes from baseline in clinical pathology or lung physiology based on:Blood gasesPulmonary function dataRadiology data	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Evaluations will include:	CT evidence of lobar volume reduction at site(s) of AeriSeal administration at 12 weeks assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.; Change from baseline at 12 and 24 weeks in RV/TLC; Change from baseline at 12 and 24 weeks in FEV1; Change from baseline at 12 and 24 weeks in FVC; Change from baseline at 12 and 24 weeks in 6 MWT; Change from baseline at 12 and 24 weeks in MRCD score; Change from baseline at 12 and 24 weeks in SGRQ total domain score	6 months

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Mordechai R Kramer, MD, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: October 23, 2012
• First Submitted That Met QC Criteria: November 13, 2012
• First Posted (Estimate): November 20, 2012

Study Record Updates

• Last Update Posted (Estimate): November 20, 2012
• Last Update Submitted That Met QC Criteria: November 13, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: emphysema; lung volume reduction therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: RMC127000 CTIL