CompletedNCT01051258Updated Jun 26, 2013

AeriSeal System for Lung Volume Reduction

A Phase 1/2 interventional study of AeriSeal System in Emphysema, Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Emphysema, sponsored by Aeris Therapeutics. Completed at 8 sites in 4 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2013-06-26.

Sponsored by Aeris Therapeutics · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 55
Allocation: Non-randomized
Ages: 40 Years and older
Sex: All

Study summary

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

Read the detailed description

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

Conditions studied

Emphysema
Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Emphysema
Lung Diseases

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Keywords

Polymeric Lung Volume Reduction (PLVR)
Biologic Lung Volume Reduction (BLVR)
AeriSeal
treatment
device
breathing
COPD
emphysema
heterogeneous
homogeneous
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 55 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Aeris Therapeutics is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 55 participants (actual)

Interventions

DeviceAeriSeal System
AeriSeal System for Lung Volume Reduction
Also known as: lung volume reduction, AeriSeal, PLVR

What researchers measure

Primary outcomes

Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio
Time frame: 12 Weeks following final treatment

Secondary outcomes

Change from baseline in RV/TLC ratio
Time frame: 24 and 48 weeks following treatment
Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator)
Time frame: 12, 24, 48 weeks following treatment
Change from baseline in MRC dyspnea score
Time frame: 12, 24, 48 weeks following treatment
Change from baseline in 6 minute walk test (MWT)
Time frame: 12, 24, 48 weeks following treatment
Change from baseline in disease-specific health related quality of life assessment (SGRQ)
Time frame: 12, 24, 48 weeks following treatment

Study locations

8 sites

Otto Wagner Spital Wien Interne Lungenabteilung
Wien, Austria
Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice
Nice, France
Chefarzt Klinik für Pneumologie
Bad Berka, Germany
Thoraxklinik Heidelberg
Heidelberg, Germany
Lungenklinik Hemer
Hemer, Germany
Medizinische Klinik und Poliklinik Klinikum Großhadern
München, Germany
Soroka Medical Center
Beer Sheva, Israel
Rabin Medical Center, Beilinson Hospital
Petach-Tikva, Israel

References and documents

Publications

Magnussen H, Kramer MR, Kirsten AM, Marquette C, Valipour A, Stanzel F, Bonnet R, Behr J, Fruchter O, Refaely Y, Eberhardt R, Herth FJ. Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. Thorax. 2012 Apr;67(4):302-8. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28. PubMed 22374920 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01051258
Lead sponsor: Aeris Therapeutics
Responsible party: Sponsor
First posted: Jan 18, 2010
Start date: Nov 2009
Primary completion: Aug 2011
Completion: Apr 2013
Last update: Jun 26, 2013

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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