Utility of the AeriSeal System in Patients With Advanced Upper Lobe Predominant Emphysema and Collateral Ventilation Assessed by the Chartis System

LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology1 site in 1 country10 target enrollmentApril 2011

ConditionsPulmonary Emphysema COPD Lung Diseases

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Pulmonary Emphysema
Sponsor: LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
Enrollment: 10
Locations: 1
Primary Endpoint: Change in Forced Expiratory Volume in one second (FEV1)
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to characterize the safety and efficacy of the AeriSeal System in patients with advanced upper lobe predominant emphysema and significant collateral ventilation as determined by the Chartis System.

Detailed Description

This is an investigator initiated, open-label, uncontrolled study to prospectively characterize the safety and efficacy of the AeriSeal System in patients with advanced upper lobe predominant emphysema found to have significant collateral ventilation using the Chartis System.

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

June 2013

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology

Responsible Party

Principal Investigator

Arschang Valipour

Ass. Prof. Department of Respiratory and Critical Care Medicine

LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology

Eligibility Criteria

Inclusion Criteria

•Willing and able to provide informed consent and to participate in the study
•Diagnosis of advanced emphysema (GOLD Stage III or Stage IV disease)
•Radiologic evidence of non-bullous upper lobe predominant heterogeneous emphysema with at least 2 target sites deemed appropriate for treatment evident by CT imaging
•DLco between 20 and 60% predicted
•Positive Collateral Ventilation as determined by the Chartis® System
•Clinically significant dyspnea (defined as a MRC dyspnea score of 2 or greater at Screening)
•Failure of standard medical therapy to provide adequate relief of symptoms (defined as regular use of standard medication for more than 1 month prior to Screening; standard medications include at least an inhaled beta agonist and inhaled anticholinergic unless medically contraindicated or prior medical failure)
•Significant airflow obstruction as demonstrated by Spirometry 15 minutes after administration of bronchodilator with:
•5% \< FEV1 \< 50% predicted using the ATS recommended calculation for expected value
•FEV1/FVC ratio \<70%

Exclusion Criteria

•Alpha-1 antitrypsin serum level of \< 80 mg/dL (i.e. \< 11 micro mol/L) at Screening
•Body mass index \< 15 kg/m2 or \> 35 kg/m
•Clinically significant asthma, chronic bronchitis or bronchiectasis as determined by the Investigator, or a significant COPD exacerbation within the past 4 months
•Use of systemic steroids \> 20 mg/day or equivalent immunosuppressive agents, heparins, oral anticoagulants (e.g., warfarin, dicumarol; note: antiplatelet drugs including aspirin and clopidogrel are permitted) or investigational medications within 4 weeks of Screening
•Allergy or sensitivity to medications required to safely perform AeriSeal System treatment under general anesthesia or conscious sedation
•Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the Screening visit
•Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
•Significant co-morbidity that carries prohibitive risks (e.g., HIV/AIDS, cancer) or is associated with less than 2-year expected survival
•Blood gases and oxygen saturation:
•SpO2 ≤ 90% on \> 4 L/min supplemental O2, at rest

Outcomes

Primary Outcomes

Change in Forced Expiratory Volume in one second (FEV1)

Time Frame: 12 Weeks

Change from baseline in FEV1 measurement after 12 weeks following completion of therapy.

Secondary Outcomes

Change in Forced Expiratory Volume in one second (FEV1).(24 Weeks)
Change in Forced Vital Capacity (FVC)(12 Weeks and 24 Weeks)
Change in ratio of Residual Volume to Total Lung Capacity (RV/TLC)(24 Weeks)
Change in distance walked in six minutes (6MWT)(24 Weeks)
Change in Medical Research Council Dyspnea (MRCD) score(24 Weeks)
Change in health related quality of life assessment (St. George's Respiratory Questionnaire)(SGRQ)(24 Weeks)
Change in Collateral Ventilation(24 Weeks)
Unanticipated Serious Adverse Device Effects (USADEs)(24 Week)