9 completed, 7 terminated, 2 withdrawn. 8 Phase 2, 6 Phase 1, 5 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 5, Terminated 3 |
| Phase 1 | 6 | Completed 5, Terminated 1 |
| Phase 3 | 5 | Terminated 2, Withdrawn 2, Completed 1 |
| Phase 4 | 1 | Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema AeriSeal Emphysematous Lung Sealant Syst - Emphysema, Chronic Obstructive Pulmonary Disease (COPD) | Phase 3 | Withdrawn | Aeris Therapeutics | 2013-09-01 | 2013-11-14 | |
| Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE) Treatment plus Optimal Medical Therapy, Optimal Medical Therapy - Pulmonary Emphysema | Phase 3 | Terminated | Aeris Therapeutics | 300 | 2012-06-01 | 2013-11-14 |
| Collateral Ventilation Effects on Response to AeriSeal System Treatment in Upper Lobe Predominant Emphysema Emphysematous Lung Sealant - Pulmonary Emphysema | Phase 4 | Terminated | Aeris Therapeutics | 100 | 2012-02-01 | 2013-11-14 |
| Post Market Registry Study of the AeriSeal System Pulmonary Emphysema | Terminated | Aeris Therapeutics | 25 | 2012-02-01 | 2013-11-14 | |
| A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema AeriSeal System - Pulmonary Emphysema, Chronic Obstructive Pulmonary Disease(COPD) | Phase 2 / Phase 3 | Terminated | Aeris Therapeutics | 18 | 2011-03-01 | 2013-11-14 |
| A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema Chronic Pulmonary Obstructive Disease, Emphysema | Terminated | Aeris Therapeutics | 54 | 2011-01-01 | 2013-11-14 | |
| AeriSeal® System for Lung Volume Reduction in Patients With Advanced Emphysema AeriSeal System - Pulmonary Emphysema, COPD | Phase 2 / Phase 3 | Completed | Aeris Therapeutics | 20 | 2010-08-01 | 2011-10-21 |
| AeriSeal System for Lung Volume Reduction AeriSeal System - Emphysema, Chronic Obstructive Pulmonary Disease (COPD) | Phase 1 / Phase 2 | Completed | Aeris Therapeutics | 55 | 2009-11-01 | 2013-06-26 |
| A Dose Ranging Study of the Aeris Polymeric Lung Volume Reduction (PLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema Polymeric Lung Volume Reduction System (PLVR) - Advanced Emphysema | Phase 1 | Completed | Aeris Therapeutics | 25 | 2008-12-01 | 2011-10-21 |
| Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Advanced Upper Lobe Predominant (ULP) Emphysema BLVR - Advanced Upper Lobe Predominant Emphysema | Phase 3 | Withdrawn | Aeris Therapeutics | 225 | 2008-12-01 | 2010-01-18 |
| Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study Biologic Lung Volume Reduction - Homogeneous Emphysema | Phase 2 | Completed | Aeris Therapeutics | 33 | 2008-02-01 | 2011-10-24 |
| US Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study Biologic Lung Volume Reduction (BLVR) - 20 mL Hydrogel - Pulmonary Emphysema, Chronic Obstructive Pulmonary Disease | Phase 2 | Completed | Aeris Therapeutics | 22 | 2007-08-01 | 2011-10-24 |
| Israeli Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel - Pulmonary Emphysema, Chronic Obstructive Pulmonary Disease | Phase 1 | Completed | Aeris Therapeutics | 16 | 2007-05-01 | 2010-01-18 |
| US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study BLVR Treatment - Pulmonary Emphysema | Phase 2 | Completed | Aeris Therapeutics | 20 | 2007-02-01 | 2011-10-24 |
| US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study BLVR System - Pulmonary Emphysema | Phase 1 | Completed | Aeris Therapeutics | 6 | 2006-06-01 | 2008-03-06 |
| Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation BLVR Hydrogel - Pulmonary Emphysema | Phase 2 | Terminated | Aeris Therapeutics | 5 | 2005-05-01 | 2010-01-18 |
| US 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study - Initial Formulation BLVR - Pulmonary Emphysema | Phase 1 | Completed | Aeris Therapeutics | 6 | 2005-04-01 | 2008-03-06 |
| Israeli 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation BLVR Hydrogel - Pulmonary Emphysema | Phase 1 / Phase 2 | Terminated | Aeris Therapeutics | 4 | 2005-01-01 | 2008-03-06 |
Emphysema (17) · Pulmonary Disease, Chronic Obstructive (17) · Pulmonary Emphysema (13) · Lung Diseases (7) · Respiratory Aspiration (5) · Respiratory Tract Diseases (5) · Pathologic Processes (3)
Hydrogels (2) · Pneumonectomy (1) · Therapeutics (1)
Israel (9) · United States (6) · Germany (5) · France (3) · Austria (2) · Netherlands (2) · Greece (1) · Italy (1) · Spain (1)
Gerard Criner, MD (3) · Mark Gotfried, MD (3) · Charlie Strange, MD (2) · Geoffrey McLennan, MD (2) · Janine McDermott, MS CCRP (2) · Mark Dransfield, MD (2) · Mark Krasna, MD (2) · Sanjiv Tewari, MD (2) · Thomas Gildea, MD (2) · William Leeds, DO (2) · Felix Herth, Prof. Dr med (1) · Issahar Ben-Dov, MD (1) · John J. Reilly, MD (1) · Manfred Wagner, Dr med (1) · Martin Hetzel, Dr med (1)