Collateral Ventilation Effects on Response to AeriSeal System Treatment in Upper Lobe Predominant Emphysema

NCT ID: NCT01520740

Last Updated: 2013-11-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-11-30

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.

Conditions

Pulmonary Emphysema

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Collateral Ventilation Positive (CV+)

Group Type: ACTIVE_COMPARATOR

Emphysematous Lung Sealant

Intervention Type: DEVICE

4 Subsegments treated - 2 each bilaterally

Collateral Ventilation Negative (CV-)

Group Type: ACTIVE_COMPARATOR

Emphysematous Lung Sealant

Intervention Type: DEVICE

4 Subsegments treated - 2 each bilaterally

Interventions

Emphysematous Lung Sealant

4 Subsegments treated - 2 each bilaterally

Intervention Type: DEVICE

Emphysematous Lung Sealant

4 Subsegments treated - 2 each bilaterally

Intervention Type: DEVICE

Other Intervention Names

AeriSeal System Treatment; AeriSeal System Treatment

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aeris Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janine McDermott, MS CCRP

Role: STUDY_DIRECTOR

Aeris Therapeutics

Locations

Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Charite Campus Virchow-Klinikum

Berlin, , Germany

Klinikum Coburg

Coburg, , Germany

Klinikum Donaustauf

Donaustauf, , Germany

Asklepios Fachkliniken Muenchen - Gauting

Gauting, , Germany

Universitatsklinikum Halle

Halle, , Germany

Asklepios Klinik Hamburg-Harburg

Hamburg, , Germany

Thoraxklinik am Uniklinikum Heidelberg

Heidelberg, , Germany

Sana Kliniken Luebeck

Lübeck, , Germany

Medizinische Klinik und Poliklinik Grosshadern

München, , Germany

Hadassah - Hebrew University Medical Center

Jerusalem, , Israel

Carmel Medical Center

Petah Tikva, , Israel

Chaim Sheba Medical Center

Tel Aviv, , Israel

Countries

Germany; Israel

Other Identifiers

03-C11-004PLV

Identifier Type: -

Identifier Source: org_study_id