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

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Trial Conditions
  • Pulmonary Emphysema
What is the purpose of this trial?

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.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
40 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Advanced emphysema refractory to medical therapy, age ≥ 40 yrs, severe airflow
obstruction and hyperinflation.

- Smoking history of ≥ 20 pack-years with abstinence from at least 16 weeks prior to
the initial Screening visit, confirmed by HbCO, CO, or cotinine through completion of
study participation.

Exclusion Criteria:

- Prior thoracic surgery or endobronchial lung volume reduction, history of recurrent
COPD exacerbations, disease associated with alpha-1 anti-trypsin deficiency or other
co-morbid conditions that could affect study outcomes.

Gender: Both
Trial Interventions
Device
  • Treatment plus Optimal Medical Therapy
Other
  • Optimal Medical Therapy
Other Information

Sponsor: Aeris Therapeutics
Phase: Phase 3
Trial ID: NCT01449292
Volunteers:  Not Accepting Healthy Volunteers

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