Emphysematous Lung Sealant Therapy in Homogeneous Emphysema

Not Applicable

• Conditions: Patients With Advanced Homogeneous Emphysema
• Interventions: Procedure: ELVR Procedure

• Registration Number: NCT01728662
• Lead Sponsor: Rabin Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2012-10-23
• Status Verified: 2012-11
• Study First Submitted QC: 2012-11-13
• Last Update Submitted: 2012-11-13
• Study First Posted: 2012-11-20
• Last Update Posted: 2012-11-20
• Study Start: 2012-12
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ELVR Procedure	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

Primary Outcome Measures

Name	Time	Method
Overall safety assessment	6 months	Overall assessment of safety based on review; 1. Clinical and laboratory results: * Serious Adverse Events (SAEs); * Serious Adverse Device Effects (SADEs); * Unanticipated Serious Adverse Device Effects (USADEs); * Physical Examinations; * Vital signs; * Serum chemistry and hematology.; 2. Changes from baseline in clinical pathology or lung physiology based on: * Blood gases; * Pulmonary function data; * Radiology data

Secondary Outcome Measures

Name	Time	Method
Efficacy Evaluations will include:	6 months	* 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

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petach Tikva, Israel