Collateral Ventilation Effects on Response to AeriSeal System Treatment in Upper Lobe Predominant Emphysema
CV+/-
1 other identifier
interventional
100
2 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2012
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2012
CompletedFirst Posted
Study publicly available on registry
January 30, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 14, 2013
November 1, 2013
1.8 years
January 26, 2012
November 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in group mean post bronchodilator Forced Exhalation Volume in one second (FEV1)
24 Weeks
Secondary Outcomes (2)
Change from Baseline in group mean 6 Minute Walk Test (6MWT) distance
24 Weeks
Change from baseline in group mean health related quality of life
24 Weeks
Study Arms (2)
Collateral Ventilation Positive (CV+)
ACTIVE COMPARATORCollateral Ventilation Negative (CV-)
ACTIVE COMPARATORInterventions
4 Subsegments treated - 2 each bilaterally
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Zentralklinik Bad Berka GmbH
Bad Berka, 99437, Germany
Charite Campus Virchow-Klinikum
Berlin, 10117, Germany
Klinikum Coburg
Coburg, 96450, Germany
Klinikum Donaustauf
Donaustauf, 93093, Germany
Asklepios Fachkliniken Muenchen - Gauting
Gauting, 82131, Germany
Universitatsklinikum Halle
Halle, 06120, Germany
Asklepios Klinik Hamburg-Harburg
Hamburg, 21075, Germany
Thoraxklinik am Uniklinikum Heidelberg
Heidelberg, D-69126, Germany
Sana Kliniken Luebeck
Lübeck, 23560, Germany
Medizinische Klinik und Poliklinik Grosshadern
München, 81377, Germany
Hadassah - Hebrew University Medical Center
Jerusalem, 91120, Israel
Carmel Medical Center
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center
Tel Aviv, 52621, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janine McDermott, MS CCRP
Aeris Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2012
First Posted
January 30, 2012
Study Start
February 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 14, 2013
Record last verified: 2013-11