Clinical trial NCT01051258: AeriSeal System for Lung Volume Reduction
Official title: A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Emphysema
Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Emphysema
Lung Diseases
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
Lead sponsor: Aeris Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-01-18
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

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.

Primary outcomes:
measure: Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio
timeFrame: 12 Weeks following final treatment
Secondary outcomes:
measure: Change from baseline in RV/TLC ratio
timeFrame: 24 and 48 weeks following treatment
measure: Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator)
timeFrame: 12, 24, 48 weeks following treatment
measure: Change from baseline in MRC dyspnea score
timeFrame: 12, 24, 48 weeks following treatment
measure: Change from baseline in 6 minute walk test (MWT)
timeFrame: 12, 24, 48 weeks following treatment
measure: Change from baseline in disease-specific health related quality of life assessment (SGRQ)
timeFrame: 12, 24, 48 weeks following treatment
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Otto Wagner Spital Wien Interne Lungenabteilung
city: Nice
country: France
facility: Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice
city: Bad Berka
country: Germany
facility: Chefarzt Klinik für Pneumologie
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: München
country: Germany
facility: Medizinische Klinik und Poliklinik Klinikum Großhadern
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Petach-Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
Study officials:
References:
citation: 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.