Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema

NCT01908933 | Withdrawn Phase 3 DMC

• 1 other identifier: 03-C13-001PLV
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to prospectively evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.

Conditions

Emphysema; Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Advanced Emphysema; Heterogeneous Lower Lobe Predominant Emphysema; Heterogeneous Upper and Lower Lobe Predominant

Outcome Measures

Primary Outcomes (1)

• Volume change by CT

  Group mean normalized change from baseline in the volume of the treated lung lobes measured by quantitative CT at 24 weeks post-treatment (defined as the sum of volume change in all treated lobes/number of treatments).

  28 - 30 weeks

Secondary Outcomes (1)

• Fraction of patients showing clinically significant improvements from baseline in one or more of the following outcomes at 24 weeks post treatment: Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), Medical Research Council Dyspnea

  28 - 30 weeks

Study Arms (1)

AeriSeal Emphysematous Lung Sealant Syst

EXPERIMENTAL

This is a prospective, open label, single-arm, multicenter, investigational study. Patients will receive either unilateral or bilateral AeriSeal System therapy as appropriate utilizing 20 mL/subsegment dosing at 2 to 4 subsegments.

Device: AeriSeal Emphysematous Lung Sealant Syst

Interventions

AeriSeal Emphysematous Lung Sealant Syst DEVICE

This is a prospective, open label, single-arm, multicenter, investigational study. Patients will receive either unilateral or bilateral AeriSeal System therapy as appropriate utilizing 20 mL/subsegment dosing at 2 to 4 subsegments.

AeriSeal Emphysematous Lung Sealant Syst

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 lower or lower and upper lobe predominant heterogeneous emphysema by CT scan
• Minimum of 2 subsegments appropriate for treatment
• 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):
• Total Lung Capacity (TLC) \> 100 % predicted
• Residual Volume (RV) \> 150 % predicted
• Diffusing Capacity of Carbon Monoxide(DLco) \> = 20 and \< = 60 percent predicted
• Oxygen saturation (SpO2) \> 90 % on \< or = 4 L/min supplemental O2, at rest
• Six-Minute Walk Test distance \> or = 150 m

You may not qualify if:

• Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, or prior lung transplantation
• 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
• 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 all dimensions \>1 / 3 of the hemithorax)
• 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)
• Allergy or sensitivity to medications required to safely undergo AeriSeal System treatment

Sponsors & Collaborators

• Aeris Therapeutics: lead

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Officials

• Felix Herth, Prof. Dr med

  Thoraxklinik am Uniklinikum Heidelberg

  PRINCIPAL INVESTIGATOR

• Wolfgang Gesierich, Dr med

  Asklepios Fachkliniken Muenchen - Gauting

  PRINCIPAL INVESTIGATOR

• Manfred Wagner, Dr med

  Klinikum Nuernberg Nord

  PRINCIPAL INVESTIGATOR

• Mordechai Kramer, Prof

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

• Martin Hetzel, Dr med

  Krankenhaus vom Roten Kreuz - Stuttgart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 26, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 14, 2013

Record last verified: 2013-11