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Pulmonary EmphysemaPhase 2/3NCT01181466

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

A Phase 2/3 study testing AeriSeal System in people with Pulmonary Emphysema and COPD, run by Aeris Therapeutics at 2 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Emphysema, COPD, Lung Diseases
What is being tested?
AeriSeal System
Type of treatment
Medical device
How many people
20 participants
Where
2 sitesIsrael
Study dates
Aug 2010to May 2011
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • -

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

  • The Soroka Medical Center

    Beersheba

  • The Rabin Medical Center

    Petah Tikva

Other trials in Israel

About this study

Official title: 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

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.

Read the 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.

Being tested
AeriSeal System
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
Medical subject headings
Pulmonary Emphysema, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiratory Aspiration, Emphysema, Pathologic Processes, Respiratory Tract Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AeriSeal SystemDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks following treatment

Secondary outcomes (6)

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

    Change from baseline at 12 weeks in RV/TLC

    Measured: 12 weeks following treatment

  2. Change in Forced Expiratory Volume in 1 Second (FEV1)

    Change from baseline at 12 weeks in FEV1

    Measured: 12 weeks following treatment

  3. Change in Forced Vital Capacity (FVC)

    Change from baseline at 12 weeks in FVC

    Measured: 12 weeks following treatment

  4. Change in distance walked in six minutes

    Change from baseline at 12 weeks in 6 Minute Walk Test (6MWT)

    Measured: 12 weeks following treatment

  5. Change in Medical Research Council Dyspnea (MRCD) score

    Change from baseline at 12 weeks in MRCD score

    Measured: 12 weeks following treatment

  6. Change in St. George's Respiratory Questionnaire (SGRQ) domain score

    Change from baseline at 12 weeks in SGRQ total domain score

    Measured: 12 weeks following treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01181466
Sponsor's protocol ID
03-C10-002PLV
Status last verified
Oct 2011
First submitted
13 Jul 2010
Last updated
21 Oct 2011
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28.

    PubMed 22374920

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing AeriSeal System in people with Pulmonary Emphysema and COPD, run by Aeris Therapeutics at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Percent Volume of Lung (time frame: 12 weeks following treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01181466, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2011.

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