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Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)

NCT01449292 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-11-14

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.

Conditions

  • Pulmonary Emphysema

Interventions

DEVICE

Treatment plus Optimal Medical Therapy

Patients will be treated with the AeriSeal System in 2 subsegments in the upper lobes of each lung (4 subsegments total). 20mL of foam sealant will be injected via catheter into each subsegment selected for treatment. Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).

OTHER

Optimal Medical Therapy

Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).

Sponsors & Collaborators

  • Aeris Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States
  • France
  • Greece
  • Israel
  • Italy
  • Netherlands
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01449292 on ClinicalTrials.gov