Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT01908933
First received: July 18, 2013
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to prospectively evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.


Condition Intervention Phase
Emphysema
Chronic Obstructive Pulmonary Disease (COPD)
Device: AeriSeal Emphysematous Lung Sealant Syst
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema

Resource links provided by NLM:


Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • Volume change by CT [ Time Frame: 28 - 30 weeks ] [ Designated as safety issue: Yes ]
    Group mean normalized change from baseline in the volume of the treated lung lobes measured by quantitative CT at 24 weeks post-treatment (defined as the sum of volume change in all treated lobes/number of treatments).


Secondary Outcome Measures:
  • Fraction of patients showing clinically significant improvements from baseline in one or more of the following outcomes at 24 weeks post treatment: Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), Medical Research Council Dyspnea [ Time Frame: 28 - 30 weeks ] [ Designated as safety issue: Yes ]
    Group mean change in baseline to week 24 in:Forced Expiratory Volume in 1 second (FEV1),Forced Vital Capacity (FVC),Medical Research Council Dyspnea (MRCD), 6 Six-Minute Walk Test (6MWT), Saint George Respiratory Questionnaire (SGRQ)


Enrollment: 0
Study Start Date: September 2013
Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AeriSeal Emphysematous Lung Sealant Syst
This is a prospective, open label, single-arm, multicenter, investigational study. Patients will receive either unilateral or bilateral AeriSeal System therapy as appropriate utilizing 20 mL/subsegment dosing at 2 to 4 subsegments.
Device: AeriSeal Emphysematous Lung Sealant Syst
This is a prospective, open label, single-arm, multicenter, investigational study. Patients will receive either unilateral or bilateral AeriSeal System therapy as appropriate utilizing 20 mL/subsegment dosing at 2 to 4 subsegments.

Detailed Description:

This is a prospective single arm study to evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide informed consent and to participate in the study
  • Age > or = 40 years at the time of the screening
  • Advanced lower or lower and upper lobe predominant heterogeneous emphysema by CT scan
  • Minimum of 2 subsegments appropriate for treatment
  • MRCD questionnaire score of 2 or greater at screening
  • Failure of medical therapy to provide relief of symptoms
  • Spirometry 15 minutes after administration of bronchodilator (BOTH):

    • FEV1 < 50 % predicted.
    • FEV1/FVC ratio <70 %
  • Lung volumes by plethysmography (BOTH):

    • Total Lung Capacity (TLC) > 100 % predicted
    • Residual Volume (RV) > 150 % predicted
  • Diffusing Capacity of Carbon Monoxide(DLco) > = 20 and < = 60 percent predicted
  • Oxygen saturation (SpO2) > 90 % on < or = 4 L/min supplemental O2, at rest
  • Six-Minute Walk Test distance > or = 150 m
  • Abstinence from smoking for at least 16 weeks prior to screening

Exclusion Criteria:

  • Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, or prior lung transplantation
  • Requirement for ventilator support (invasive or non-invasive)
  • Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks of Screening visit
  • Pulmonary hypertension, defined as:

    • Echocardiogram with estimated peak systolic pressure > 45 mmHg in the presence of tricuspid valve regurgitation stated in the echocardiogram report
    • If the echocardiogram shows peak systolic pressure > 45 mmHg, right heart catheterization is required to rule out pulmonary hypertension, defined as peak systolic pressure > 45 mmHg or mean pressure > 35 mmHg
  • Clinically significant asthma (reversible airway obstruction) or bronchiectasis
  • CT scan: Presence of the following radiologic abnormalities:

    • Pulmonary nodule on CT scan greater that 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)
    • Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate
    • Significant interstitial lung disease
    • Significant pleural disease
    • Giant bullous disease (a predominant bulla > 10 cm in all dimensions >1 / 3 of the hemithorax)
  • 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)
  • Allergy or sensitivity to medications required to safely undergo AeriSeal System treatment
  • Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the screening visit
  • Body mass index < 15 kg/m2 or > 35 kg/m2
  • Female patient pregnant or breast-feeding or planning to be pregnant in the next year
  • Significant comorbidity that carries prohibitive risks or is associated with less than 2-year expected survival, including any of the following:

    • HIV/AIDS
    • Active malignancy
    • Stroke or Transient Ischemia Attack (TIA) within 12 months of screening
    • Myocardial infarction within 12 months of screening
    • Congestive heart failure within 12 months of screening defined at clinical evidence of right or left hear failure or left ventricular ejection fraction < 45 % on echocardiogram
  • 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 such as alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908933

Sponsors and Collaborators
Aeris Therapeutics
Investigators
Principal Investigator: Felix Herth, Prof. Dr med Thoraxklinik am Uniklinikum Heidelberg
Principal Investigator: Wolfgang Gesierich, Dr med Asklepios Fachkliniken Muenchen - Gauting
Principal Investigator: Manfred Wagner, Dr med Klinikum Nuernberg Nord
Principal Investigator: Mordechai Kramer, Prof Rabin Medical Center
Principal Investigator: Martin Hetzel, Dr med Krankenhaus vom Roten Kreuz - Stuttgart
  More Information

No publications provided

Responsible Party: Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT01908933     History of Changes
Other Study ID Numbers: 03-C13-001PLV
Study First Received: July 18, 2013
Last Updated: November 13, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health

Keywords provided by Aeris Therapeutics:
Advanced Emphysema
Heterogeneous Lower Lobe Predominant Emphysema
Heterogeneous Upper and Lower Lobe Predominant

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014