US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

Status Completed

Clinical Trial Summary

Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.

Clinical Trial Description

Prospective, open-label, non-controlled, multi-center Phase 2 Study evaluating the efficacy and safety of the 10 mL BLVR System in patients with advanced upper lobe predominant emphysema. Twenty patients will be divided into 2 groups of 10 patients each and treated under conscious sedation at a total of 8 subsegments. Group 1 will be treated in 4 subsegments in 1 lung and have a second treatment of 4 subsegments in the other lung 6 to 12 weeks later. Group 2 will receive treatment at 8 subsegments (4 in each lung) during a single treatment session if possible; if not completed in 1 session the remaining subsegments will be treated 6 to 12 weeks later. Patients will be followed 96 weeks after completion of the final BLVR treatment. All patients will receive standard medical therapy in addition to BLVR treatment. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00435253
Study type	Interventional
Source	Aeris Therapeutics
Contact
Status	Completed
Phase	Phase 2
Start date	February 2007
Completion date	June 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT00995852` - Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study	Phase 2/Phase 3
Completed	`NCT01860898` - A Phase I Study of iPS Cell Generation From Patients With COPD	N/A
Completed	`NCT00123422` - Innovation in Pulmonary Rehabilitation	N/A
Recruiting	`NCT02879331` - Clinical Study to Evaluate the Exercise Capacity in Patients With Severe Emphysema Treated With Coils	N/A
Completed	`NCT01507415` - Do the SPPB and 4-metre Gait Speed Predict Hospital Readmission in Patients Hospitalised for Acute Exacerbation if COPD?	N/A
Completed	`NCT01051258` - AeriSeal System for Lung Volume Reduction	Phase 1/Phase 2
Completed	`NCT00680056` - Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients	Phase 4
Completed	`NCT01872624` - Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema	N/A
Completed	`NCT01110252` - Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease	N/A
Completed	`NCT00517998` - Israeli Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study	Phase 1
Terminated	`NCT00205920` - Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation	Phase 2
Withdrawn	`NCT01849159` - Clinical Study of the Efficacy and Safety of the Application of Allogeneic Mesenchymal (Stromal) Cells of Bone Marrow, Cultured Under the Hypoxia in the Treatment of Patients With Severe Pulmonary Emphysema	Phase 1/Phase 2
Completed	`NCT01869205` - The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients	Phase 3
Terminated	`NCT01320566` - 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	Phase 2/Phase 3
Completed	`NCT00683722` - PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)	Phase 2
Active, not recruiting	`NCT04465461` - Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion	N/A
Completed	`NCT04012359` - Description of Bullous Emphysema Using Lung Ultrasound and Comparison to the Characteristics of Pneumothorax
Recruiting	`NCT04918706` - Allogeneic MSC Treatment for Pulmonary Emphysema	Phase 2
Terminated	`NCT01449292` - Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)	Phase 3
Completed	`NCT00347659` - US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study	Phase 1