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Completed

NCT Number: NCT01051258

AeriSeal System for Lung Volume Reduction

The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.

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Key information

Conditions

Emphysema Chronic Disease Chronic Obstructive Pulmonary Disease (COPD) Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Emphysema Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Otto Wagner Spital Wien Interne Lungenabteilung, Vienna, Austria

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About this study

The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced homogeneous and heterogeneous emphysema.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC<70% predicted, FEV1 of <50% predicted, TLC > 100% predicted, and RV > 135% predicted.
  • Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
  • Patients must be > 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.

Treatment and study plan

AeriSeal System

Device

AeriSeal System for Lung Volume Reduction

Other names: lung volume reduction, AeriSeal, PLVR

Primary outcomes

  1. Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio

    Time frame: 12 Weeks following final treatment

Secondary outcomes

  1. Change from baseline in RV/TLC ratio

    Time frame: 24 and 48 weeks following treatment

  2. Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator)

    Time frame: 12, 24, 48 weeks following treatment

  3. Change from baseline in MRC dyspnea score

    Time frame: 12, 24, 48 weeks following treatment

  4. Change from baseline in 6 minute walk test (MWT)

    Time frame: 12, 24, 48 weeks following treatment

  5. Change from baseline in disease-specific health related quality of life assessment (SGRQ)

    Time frame: 12, 24, 48 weeks following treatment

Sponsors and collaborators

Lead sponsor

Aeris Therapeutics

Industry

Registry information

Official study title

A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Jan 18, 2010
Registry last updated
Jun 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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