AeriSeal System in Patients With Advanced Upper Lobe Predominant Emphysema and Collateral Ventilation (CV+)

• ClinicalTrials.gov Identifier: NCT01460108
• Recruitment Status: Unknown
• First Posted: October 26, 2011
• Last Update Posted: October 27, 2011
• Sponsor: LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
• Information provided by (Responsible Party): Arschang Valipour, LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Emphysema; COPD; Lung Diseases	Device: AeriSeal System	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Utility of the AeriSeal System in Patients With Advanced Upper Lobe Predominant Emphysema and Collateral Ventilation Assessed by the Chartis System
• Study Start Date: April 2011
• Estimated Primary Completion Date: December 2012
• Estimated Study Completion Date: June 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: AeriSeal System Treatment; Candidates for the trial include patients with advanced non-bullous upper lobe predominant emphysema who have a DLco between 20 and 60% predicted and target sites in at least 1 upper lobe. Eligible and consented patients will undergo evaluation with the Chartis System, and only patients found to have significant collateral ventilation will be enrolled.	Device: AeriSeal System; 20 mL; Other Name: Emphasemateous Lung Sealant

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Change in Forced Expiratory Volume in one second (FEV1). [ Time Frame: 24 Weeks ]
   Change from baseline in FEV1 at 24 Weeks following completion of therapy
2. Change in Forced Vital Capacity (FVC) [ Time Frame: 12 Weeks and 24 Weeks ]
   Change from baseline in FVC at 12 and 24 weeks following completion of therapy.
3. Change in ratio of Residual Volume to Total Lung Capacity (RV/TLC) [ Time Frame: 24 Weeks ]
   Change from baseline in RV/TLC ratio at 24 weeks following completion of therapy.
4. Change in distance walked in six minutes (6MWT) [ Time Frame: 24 Weeks ]
   Change from baseline in 6MWT distance at 24 weeks following completion of therapy.
5. Change in Medical Research Council Dyspnea (MRCD) score [ Time Frame: 24 Weeks ]
   Change from baseline in MRCD score at 24 weeks following completion of therapy
6. Change in health related quality of life assessment (St. George's Respiratory Questionnaire)(SGRQ) [ Time Frame: 24 Weeks ]
   Change from baseline in disease-specific health related quality of life assessment (SGRQ) at 24 weeks following completion of therapy.
7. Change in Collateral Ventilation [ Time Frame: 24 Weeks ]
   Change from baseline in collateral ventilation at 24 weeks following completion of therapy as measured by the Chartis System.
8. Unanticipated Serious Adverse Device Effects (USADEs) [ Time Frame: 24 Week ]
   Record of any/all USADEs up to 24 weeks follwoing completion of therapy.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Arschang Valipour, MD, FCCP; 43-1-91060-41008; arschang.valipour@wienkav.at

Locations

Austria

Otto-Wagner-Spital; Recruiting

Wien, Austria, 1140

Contact: Arschang Valipour, MD, FCCP 43-1-91060-41008 arschang.valipour@wienkav.at

Principal Investigator: Arschang Valipour, MD, FCCP

Sponsors and Collaborators

LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology

Investigators

• Principal Investigator: Arschang Valipour, MD, FCCP; Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie

More Information

• Responsible Party: Arschang Valipour, Ass. Prof. Department of Respiratory and Critical Care Medicine, LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
• ClinicalTrials.gov Identifier: NCT01460108
• Other Study ID Numbers: EK_11_027_0311
• First Posted: October 26, 2011
• Last Update Posted: October 27, 2011
• Last Verified: October 2011

Keywords provided by Arschang Valipour, LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology:

PLVR; AeriSeal; Treatment; Device; Breathing; COPD; emphysema; polymeric lung volume reduction; heterogeneous; homogeneous; Chronic Obstructive Pulmonary Disease

Additional relevant MeSH terms:

Lung Diseases; Pulmonary Emphysema; Emphysema; Respiratory Tract Diseases; Pathologic Processes; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive