Completed

NCT Number: NCT01181466

AeriSeal® System for Lung Volume Reduction in Patients With Advanced Emphysema

The purpose of this study is to assess the procedural and post-procedural safety and efficacy of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with GOLD Stage III/IV homogeneous or heterogeneous emphysema.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulmonary Emphysema COPD Chronic Disease Disease Attributes Emphysema Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The Soroka Medical Center, Beersheba, Israel

About this study

Emphysema is a progressive, debilitating disease characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic, occupational, and environmental causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death worldwide. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come.

The AeriSeal System is a novel device system being developed for the treatment of advanced emphysema. The AeriSeal System is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC<70% predicted, FEV1 of <50% predicted, TLC > 100% predicted, and RV > 135% predicted.
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.
Patients must be > 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.

Exclusion criteria

Treatment and study plan

AeriSeal System

Device

The AeriSeal System will be Administered at 3 to 4 Pulmonary Subsegments During a Single Treatment session.

Primary outcomes

Change in Percent Volume of Lung

Time frame: 12 weeks following treatment

Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 12 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.

Secondary outcomes

Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)

Time frame: 12 weeks following treatment

Change from baseline at 12 weeks in RV/TLC
Change in Forced Expiratory Volume in 1 Second (FEV1)

Time frame: 12 weeks following treatment

Change from baseline at 12 weeks in FEV1
Change in Forced Vital Capacity (FVC)

Time frame: 12 weeks following treatment

Change from baseline at 12 weeks in FVC
Change in distance walked in six minutes

Time frame: 12 weeks following treatment

Change from baseline at 12 weeks in 6 Minute Walk Test (6MWT)
Change in Medical Research Council Dyspnea (MRCD) score

Time frame: 12 weeks following treatment

Change from baseline at 12 weeks in MRCD score
Change in St. George's Respiratory Questionnaire (SGRQ) domain score

Time frame: 12 weeks following treatment

Change from baseline at 12 weeks in SGRQ total domain score

Sponsors and collaborators

Lead sponsor

Aeris Therapeutics

Industry

Registry information

Official study title

A 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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Aug 13, 2010
Registry last updated: Oct 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed