Clinical trial NCT01460108: AeriSeal System in Patients With Advanced Upper Lobe Predominant Emphysema and Collateral Ventilation
Official title: Utility of the AeriSeal System in Patients With Advanced Upper Lobe Predominant Emphysema and Collateral Ventilation Assessed by the Chartis System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pulmonary Emphysema
COPD
Lung Diseases
Keywords: PLVR
AeriSeal
Treatment
Device
Breathing
COPD
emphysema
polymeric lung volume reduction
heterogeneous
homogeneous
Chronic Obstructive Pulmonary Disease
Lead sponsor: LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
Sponsor class: NETWORK
First posted: 2011-10-26
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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%
* Physiological evidence of hyperinflation with Lung volumes (plethysmographic) of:
* TLC \> 100% predicted using the ATS recommended calculation for expected value
* RV \> 135% predicted using the ATS recommended calculation for expected value
* Six-Minute Walk Test distance ≥ 150 m
* Abstinence from inhaled tobacco use for at least 16 weeks prior to the initial Screening visit until the end of the study
* Female patients are either post-menopausal or surgically sterile. Women with child-bearing potential will not be included in this study

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
  * PaCO2 ≥ 55mmHg
  * DLCO \< 20% or \> 60% predicted for patients with heterogeneous emphysema
* Chest CT scan: Presence of any of the following radiologic abnormalities:

  * Pulmonary nodule on CT scan greater than 1.0 cm in diameter (Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/PET)
  * Giant Bullous Disease
  * Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate
  * Significant interstitial lung disease (based upon investigator judgment)
  * Significant pleural disease (based upon investigator judgment)
  * Any condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient

Primary outcomes:
measure: Change in Forced Expiratory Volume in one second (FEV1)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Change in Forced Expiratory Volume in one second (FEV1).
timeFrame: 24 Weeks
measure: Change in Forced Vital Capacity (FVC)
timeFrame: 12 Weeks and 24 Weeks
measure: Change in ratio of Residual Volume to Total Lung Capacity (RV/TLC)
timeFrame: 24 Weeks
measure: Change in distance walked in six minutes (6MWT)
timeFrame: 24 Weeks
measure: Change in Medical Research Council Dyspnea (MRCD) score
timeFrame: 24 Weeks
measure: Change in health related quality of life assessment (St. George's Respiratory Questionnaire)(SGRQ)
timeFrame: 24 Weeks
measure: Change in Collateral Ventilation
timeFrame: 24 Weeks
measure: Unanticipated Serious Adverse Device Effects (USADEs)
timeFrame: 24 Week
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Otto-Wagner-Spital
Study officials:
affiliation: Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie
name: Arschang Valipour, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
References: