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

NCT01181466 | Completed Phase 2 DMC

• 1 other identifier: 03-C10-002PLV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Emphysema; COPD; Lung Diseases

Keywords

PLVR; BLVR; AeriSeal; treatment; device; breathing; COPD; emphysema; polymeric lung volume reduction; biologic lung volume reduction; heterogeneous; homogeneous; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Change in Percent Volume of Lung

  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.

  12 weeks following treatment

Secondary Outcomes (6)

• Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)

  12 weeks following treatment

• Change in Forced Expiratory Volume in 1 Second (FEV1)

  12 weeks following treatment

• Change in Forced Vital Capacity (FVC)

  12 weeks following treatment

• Change in distance walked in six minutes

  12 weeks following treatment

• Change in Medical Research Council Dyspnea (MRCD) score

  12 weeks following treatment

Interventions

AeriSeal System DEVICE

The AeriSeal System will be Administered at 3 to 4 Pulmonary Subsegments During a Single Treatment session.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Aeris Therapeutics: lead

Study Sites (2)

The Soroka Medical Center

Beersheba, Israel

Location

The Rabin Medical Center

Petah Tikva, Israel

Location

Related Publications (1)

• 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.

  PMID: 22374920 DERIVED

Related Links

• Aeris Therapeutics

MeSH Terms

Conditions

Pulmonary Emphysema; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Aspiration; Emphysema; Pathologic Processes; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: August 13, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 21, 2011

Record last verified: 2011-10

Locations

IL (2)