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A Continuation 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

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ClinicalTrials.gov Identifier: NCT01320566
Recruitment Status : Terminated
First Posted : March 22, 2011
Last Update Posted : November 14, 2013
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics

March 15, 2011
March 22, 2011
November 14, 2013
March 2011
January 2012   (Final data collection date for primary outcome measure)
Change from baseline in Percent Volume of Lung [ Time Frame: 48 Weeks following treatment ]
Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 48 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.
Change in Percent Volume of Lung [ Time Frame: 48 Weeks following treatment ]
Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 48 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm.
Complete list of historical versions of study NCT01320566 on ClinicalTrials.gov Archive Site
  • Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) [ Time Frame: 24 and 48 weeks following treatment ]
    Change from baseline at 24 and 48 weeks in RV/TLC
  • Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 24 and 48 weeks following treatment ]
    Change from baseline at 24 and 48 weeks in FEV1
  • Change in Forced Vital Capacity (FVC) [ Time Frame: 24 and 48 weeks following treatment ]
    Change from baseline at 24 and 48 weeks in FVC
  • Change in distance walked in six minutes [ Time Frame: 24 and 48 weeks following treatment ]
    Change from baseline at 24 and 48 weeks in 6 Minutes Walk Test (6MWT)
  • Change in Medical Research Council Dyspnea (MRCD) score [ Time Frame: 24 and 48 weeks following treatment ]
    Change from baseline at 24 and 48 weeks in MRCD score
  • Change in St. George's Respiratory Questionnaire (SGRQ)domain score [ Time Frame: 24 and 48 weeks following treatment ]
    Change from baseline at 24 and 48 weeks in SGRQ total domain score
Same as current
Not Provided
Not Provided
 
A Continuation 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
A Continuation 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
The purpose of this study is to assess the long term safety and efficacy of AeriSeal System treatment administered at up to 4 subsegments during a single treatment session for lung volume reduction in patients with advanced emphysema through 48 weeks after treatment.

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pulmonary Emphysema
  • Chronic Obstructive Pulmonary Disease(COPD)
  • Lung Diseases
Device: AeriSeal System
Not applicable. Follow-Up study only.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
Same as current
November 2013
January 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have been enrolled in the 03-C10-002PLV Aeris' Investigational Study and completed a minimum of 12 weeks of follow-up following AeriSeal System treatment.
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01320566
03-C10-003PLV
Yes
Not Provided
Not Provided
Aeris Therapeutics
Aeris Therapeutics
Not Provided
Not Provided
Aeris Therapeutics
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP