AeriSeal® System for Lung Volume Reduction in Patients With Advanced Emphysema

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Aeris Therapeutics

ClinicalTrials.gov Identifier:

NCT01181466

First received: July 13, 2010

Last updated: October 20, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	July 13, 2010
Last Updated Date	October 20, 2011
Start Date ^ICMJE	August 2010
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 20, 2011)	Change in Percent Volume of Lung [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 12 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.
Original Primary Outcome Measures ^ICMJE (submitted: August 12, 2010)	Primary Outcome Measures: [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] CT evidence of lobar volume reduction at site(s) of AeriSeal administration at 12 weejs assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.
Change History	Complete list of historical versions of study NCT01181466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 20, 2011)	Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] Change from baseline at 12 weeks in RV/TLC Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] Change from baseline at 12 weeks in FEV1 Change in Forced Vital Capacity (FVC) [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] Change from baseline at 12 weeks in FVC Change in distance walked in six minutes [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] Change from baseline at 12 weeks in 6 Minute Walk Test (6MWT) Change in Medical Research Council Dyspnea (MRCD) score [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] Change from baseline at 12 weeks in MRCD score Change in St. George's Respiratory Questionnaire (SGRQ) domain score [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] Change from baseline at 12 weeks in SGRQ total domain score
Original Secondary Outcome Measures ^ICMJE (submitted: August 12, 2010)	Other efficacy outcome measures: [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] Change from baseline at 12 weeks in RV/TLC Other efficacy outcome measures [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] Change from baseline at 12 weeks in FEV1 other efficacy outcome measures [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] Change from baseline at 12 weeks in FVC Other efficacy outcome measures [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] Change in baseline at 12 weeks in 6 MWT Other efficacy outcome measures [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] Change from baseline at 12 weeks in MRCD score Other efficacy outcome measures [ Time Frame: 12 weeks following treatment ] [ Designated as safety issue: No ] Change in baseline at 12 weeks in SGRQ total domain score
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	AeriSeal® System for Lung Volume Reduction in Patients With Advanced Emphysema
Official Title ^ICMJE	A Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema
Brief Summary	The purpose of this study is to assess the procedural and post-procedural safety and efficacy of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with GOLD Stage III/IV homogeneous or heterogeneous emphysema.
Detailed Description	Emphysema is a progressive, debilitating disease characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic, occupational, and environmental causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death worldwide. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come. The AeriSeal System is a novel device system being developed for the treatment of advanced emphysema. The AeriSeal System is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Pulmonary Emphysema COPD Lung Diseases
Intervention ^ICMJE	Device: AeriSeal System The AeriSeal System will be Administered at 3 to 4 Pulmonary Subsegments During a Single Treatment session.
Study Arm (s)	Not Provided
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. Epub 2012 Feb 28.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	May 2011
Primary Completion Date	May 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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. Exclusion Criteria: -
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01181466
Other Study ID Numbers ^ICMJE	03-C10-002PLV
Has Data Monitoring Committee	Yes
Responsible Party	Aeris Therapeutics
Study Sponsor ^ICMJE	Aeris Therapeutics
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Aeris Therapeutics
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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