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Pulmonary EmphysemaPhase 2/3NCT01320566

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

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
AeriSeal System
Type of treatment
Medical device
How many people
18 participants
Where
2 sitesIsrael
Study dates
Mar 2011to Nov 2013
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 been enrolled in the 03-C10-002PLV Aeris' Investigational Study and completed a minimum of 12 weeks of follow-up following AeriSeal System treatment.

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

  • The Soroka Medical Center

    Beersheba, 84101

  • The Rabin Medical Center

    Petah Tikva, 49100

Other trials in Israel

About this study

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.

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
Polymeric Lung Volume Reduction (PLVR), Bolilogic Lung Volume Reduction (BLVR), AeriSeal, treatment, device, breathing, COPD, emphysema, 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

    Not applicable. Follow-Up study only.

What is being measured

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

  1. Change from baseline in Percent Volume of Lung

    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.

    Measured: 48 Weeks following treatment

Secondary outcomes (6)

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

    Change from baseline at 24 and 48 weeks in RV/TLC

    Measured: 24 and 48 weeks following treatment

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

    Change from baseline at 24 and 48 weeks in FEV1

    Measured: 24 and 48 weeks following treatment

  3. Change in Forced Vital Capacity (FVC)

    Change from baseline at 24 and 48 weeks in FVC

    Measured: 24 and 48 weeks following treatment

  4. Change in distance walked in six minutes

    Change from baseline at 24 and 48 weeks in 6 Minutes Walk Test (6MWT)

    Measured: 24 and 48 weeks following treatment

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

    Change from baseline at 24 and 48 weeks in MRCD score

    Measured: 24 and 48 weeks following treatment

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

    Change from baseline at 24 and 48 weeks in SGRQ total domain score

    Measured: 24 and 48 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 posted22 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionJan 2012
  4. Study completionNov 2013

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
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01320566
Sponsor's protocol ID
03-C10-003PLV
Status last verified
Nov 2013
First submitted
15 Mar 2011
Last updated
14 Nov 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing AeriSeal System in people with Pulmonary Emphysema and Chronic Obstructive Pulmonary Disease(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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 14 Nov 2013. 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 was stopped early. Results are not available in the source record.

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 from baseline in Percent Volume of Lung (time frame: 48 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 NCT01320566.

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 14 Nov 2013.

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