AeriSeal System in Patients With Advanced Upper Lobe Predominant Emphysema and Collateral Ventilation

NCT01460108 | Unknown Phase 4

• 1 other identifier: EK_11_027_0311
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Emphysema; COPD; Lung Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Forced Expiratory Volume in one second (FEV1)

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

  12 Weeks

Secondary Outcomes (8)

• 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

Study Arms (1)

AeriSeal System Treatment

EXPERIMENTAL

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

Interventions

AeriSeal System DEVICE

20 mL

Also known as: Emphasemateous Lung Sealant

AeriSeal System Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• % \< 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology: lead

Study Sites (1)

Otto-Wagner-Spital

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Pulmonary Emphysema; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Aspiration; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Officials

• Arschang Valipour, MD, FCCP

  Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arschang Valipour, MD, FCCP

CONTACT

43-1-91060-41008; arschang.valipour@wienkav.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. Department of Respiratory and Critical Care Medicine

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 26, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: October 27, 2011

Record last verified: 2011-10

Locations

AU (1)