A Dose Ranging Study of the Aeris Polymeric Lung Volume Reduction (PLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT00884962
First received: April 20, 2009
Last updated: October 20, 2011
Last verified: October 2011

April 20, 2009
October 20, 2011
December 2008
May 2010   (final data collection date for primary outcome measure)
Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
Change from baseline in RV/TLC ratio at 12 and 24 weeks following treatment
Not Provided
Complete list of historical versions of study NCT00884962 on ClinicalTrials.gov Archive Site
  • Change in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
    o Change from baseline in FEV1 (post bronchodilator) at 12 and 24 weeks following treatment
  • Change in Forced Vital Capacity (FVC) [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline in FVC (post bronchodilator) at 12 and 24 weeks following treatment
  • Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline in DLco at 12 and 24 weeks following treatment
  • Change in Medical Research Council Dyspnea (MRCD) score [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline in MRCD score at 12 and 24 weeks
  • Change in distance walked in six minutes [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline at 12 and 248 weeks in 6 Minutes Walk Test (6MWT)
  • Change in St. George's Respiratory Questionnaire (SGRQ) domain score [ Time Frame: 12 and 24 weeks following treatment ] [ Designated as safety issue: No ]
    Change from baseline in disease-specific health related quality of life assessment (SGRQ) at 12 and 24 weeks following treatment
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A Dose Ranging Study of the Aeris Polymeric Lung Volume Reduction (PLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
Not Provided

This is a multi-center, open-label, non-controlled Pilot Study. Approximately 24 patients will be assigned to one of 3 treatment groups (8 patients each group). Patients in each group will receive 2, 4, and 6 (3 followed by a retreatment of 3) subsegmental treatments, respectively. All patients will receive treatment in a single lung under conscious sedation or general anesthesia. Patients will be followed for 24 weeks after completion of PLVR treatment(s). Upon completion of 12-week follow-up, all safety and efficacy data will be analyzed to determine an effective treatment dose. Thereafter, Group 1 patients may elect to be retreated at additional sites so that their total dose received is consistent with the effective dose. All study patients will receive standard medical therapy in addition to PLVR.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Emphysema
Device: Polymeric Lung Volume Reduction System (PLVR)
20ml (each) of polymer will be injected into 2, 3 or 4 subsegments during the first treatment. Eligible patients may have 20ml (each) of polymer will be injected into 2 or 3 subsegments during the second treatment.
Experimental: PLVR
Intervention: Device: Polymeric Lung Volume Reduction System (PLVR)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a diagnosis of advanced upper lobe predominant (ULP) emphysema or advanced disease in the superior lower lobes as defined by FEV1/FVC <70 % predicted, FEV1 of < 50% predicted, TLC > 100% of 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 pre-specified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00884962
03-C08-003PLV
Not Provided
Aeris Therapeutics
Aeris Therapeutics
Not Provided
Not Provided
Aeris Therapeutics
October 2011

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