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

Pulmonary Emphysema Clinical Trial

— CV+/-  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01520740
• Other study ID #: 03-C11-004PLV
• Status: Terminated
• Phase: Phase 4
• First received: January 26, 2012
• Last updated: November 13, 2013
• Start date: February 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Aeris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

• a-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 a-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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Device:
• Emphysematous Lung Sealant
4 Subsegments treated - 2 each bilaterally
• Emphysematous Lung Sealant
4 Subsegments treated - 2 each bilaterally

Locations

Country	Name	City	State
Germany	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	Luebeck
Germany	Medizinische Klinik und Poliklinik Grosshadern	Munchen
Israel	Hadassah - Hebrew University Medical Center	Jerusalem
Israel	Carmel Medical Center	Petach-Tikva
Israel	Chaim Sheba Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Aeris Therapeutics

Countries where clinical trial is conducted

Germany,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in group mean post bronchodilator Forced Exhalation Volume in one second (FEV1)		24 Weeks	No
Secondary	Change from Baseline in group mean 6 Minute Walk Test (6MWT) distance		24 Weeks	No
Secondary	Change from baseline in group mean health related quality of life	Change from baseline in group mean health related quality of life, measured in terms of St. George's Respiratory Questionnaire (SGRQ) total domain score	24 Weeks	No