Patients With Advanced Homogeneous Emphysema Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 8 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years to 85 Years |
| Eligibility |
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) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Rabin Medical Center | Petach Tikva |
| Lead Sponsor | Collaborator |
|---|---|
| Rabin Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 Examinations Vital signs Serum chemistry and hematology. Changes from baseline in clinical pathology or lung physiology based on: Blood gases Pulmonary function data Radiology data |
6 months | No |
| Secondary | 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 | No |