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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01520740
Recruitment Status : Terminated
First Posted : January 30, 2012
Last Update Posted : November 14, 2013
Information provided by (Responsible Party):
Aeris Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Emphysema Device: Emphysematous Lung Sealant Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Collateral Ventilation Effects on Response to AeriSeal System Treatment in Upper Lobe Predominant Emphysema
Study Start Date : February 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline in group mean post bronchodilator Forced Exhalation Volume in one second (FEV1) [ Time Frame: 24 Weeks ]

Secondary Outcome Measures :
  1. Change from Baseline in group mean 6 Minute Walk Test (6MWT) distance [ Time Frame: 24 Weeks ]
  2. Change from baseline in group mean health related quality of life [ Time Frame: 24 Weeks ]
    Change from baseline in group mean health related quality of life, measured in terms of St. George's Respiratory Questionnaire (SGRQ) total domain score

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01520740

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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
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
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Study Director: Janine McDermott, MS CCRP Aeris Therapeutics

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Responsible Party: Aeris Therapeutics Identifier: NCT01520740     History of Changes
Other Study ID Numbers: 03-C11-004PLV
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013
Keywords provided by Aeris Therapeutics:
Gold Stage III
Gold Stage IV
Chronic Obstructive Pulmonary Disease
Lung Volume Reduction Surgery
Bronchoscopic Lung Volume Reduction
Upper Lobe Predominant
Additional relevant MeSH terms:
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Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases