Collateral Ventilation Effects on Response to AeriSeal System Treatment in Upper Lobe Predominant Emphysema (CV+/-)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT01520740
First received: January 26, 2012
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

This study will evaluate the effects of baseline collateral ventilation status on outcomes following treatment with AeriSeal System in patients with advanced upper-lobe predominant heterogenous emphysema.


Condition Intervention Phase
Pulmonary Emphysema
Device: Emphysematous Lung Sealant
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Collateral Ventilation Effects on Response to AeriSeal System Treatment in Upper Lobe Predominant Emphysema

Resource links provided by NLM:


Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • Change from baseline in group mean post bronchodilator Forced Exhalation Volume in one second (FEV1) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in group mean 6 Minute Walk Test (6MWT) distance [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline in group mean health related quality of life [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Change from baseline in group mean health related quality of life, measured in terms of St. George's Respiratory Questionnaire (SGRQ) total domain score


Estimated Enrollment: 100
Study Start Date: February 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Collateral Ventilation Positive (CV+) Device: Emphysematous Lung Sealant
4 Subsegments treated - 2 each bilaterally
Other Name: AeriSeal System Treatment
Active Comparator: Collateral Ventilation Negative (CV-) Device: Emphysematous Lung Sealant
4 Subsegments treated - 2 each bilaterally
Other Name: AeriSeal System Treatment

  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 upper lobe predominant emphysema by CT scan
  • Two (2) subsegments appropriate for treatment based upon CT scan in 2 different upper lobe segments in each lung (total 4 available subsegments)
  • 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):

    • TLC > 100% predicted
    • RV > 150% predicted
  • DLco > or = 20 and < or = 60% 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, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
  • 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
  • α-1 antitrypsin serum level of <80 mg/dl (immunodiffusion) or <11µmol/L (nephelometry) at Screening visit in the absence of enzyme replacement therapy. Patients with documented α-1 antitrypsin deficiency requiring replacement therapy are excluded from the study participation.
  • 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 diameter)
  • 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) and investigational medications within 4 weeks of screening
  • 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520740

Locations
Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany, 99437
Charite Campus Virchow-Klinikum
Berlin, Germany, 10117
Klinikum Coburg
Coburg, Germany, 96450
Klinikum Donaustauf
Donaustauf, Germany, 93093
Asklepios Fachkliniken Muenchen - Gauting
Gauting, Germany, 82131
Universitatsklinikum Halle
Halle, Germany, 06120
Asklepios Klinik Hamburg-Harburg
Hamburg, Germany, 21075
Thoraxklinik am Uniklinikum Heidelberg
Heidelberg, Germany, D-69126
Sana Kliniken Luebeck
Luebeck, Germany, 23560
Medizinische Klinik und Poliklinik Grosshadern
Munchen, Germany, 81377
Israel
Hadassah - Hebrew University Medical Center
Jerusalem, Israel, 91120
Carmel Medical Center
Petach-Tikva, Israel, 49100
Chaim Sheba Medical Center
Tel Aviv, Israel, 52621
Sponsors and Collaborators
Aeris Therapeutics
Investigators
Study Director: Janine McDermott, MS CCRP Aeris Therapeutics
  More Information

No publications provided

Responsible Party: Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT01520740     History of Changes
Other Study ID Numbers: 03-C11-004PLV
Study First Received: January 26, 2012
Last Updated: November 13, 2013
Health Authority: Germany: Ethics Commission
Israel: Ministry of Health

Keywords provided by Aeris Therapeutics:
Gold Stage III
Gold Stage IV
Chronic Obstructive Pulmonary Disease
COPD
Lung Volume Reduction Surgery
LVRS
Bronchoscopic Lung Volume Reduction
BLVR
Upper Lobe Predominant
ULP
Heterogeneous
Homogeneous

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 14, 2014