AzTrials
AzTrials

Advanced EmphysemaPhase 1NCT00884962

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

A Phase 1 study testing Polymeric Lung Volume Reduction System (PLVR) in people with Advanced Emphysema, run by Aeris Therapeutics at 6 sites in Germany.

Completed

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Advanced Emphysema
What is being tested?
Polymeric Lung Volume Reduction System (PLVR)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
6 sitesGermany
Study dates
Dec 2008to May 2010
Phase
Phase 1
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 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.

Who cannot join

None listed.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Chefarzt Klinik für Pneumologie

    Bad Berka

  • Charité Universitätsmedizin Medizinische Klinik Infektiologie und Pulmologie

    Berlin

  • Pneumologisches Forschungsinstitut

    Großhansdorf

  • Thoraxklinik Heidelberg

    Heidelberg

  • Lungenklinik Hemer

    Hemer

  • Medizinische Klinik und Poliklinik Klinikum Großhadern

    Munich

Other trials in Germany

About this study

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.

Being tested
Polymeric Lung Volume Reduction System (PLVR)
Keywords
emphysema, aeris, PLVR, BLVR, germany, treatment, device, breathing
Medical subject headings
Emphysema, Respiratory Aspiration

What participants receive

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

  • Polymeric Lung Volume Reduction System (PLVR)Device

    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.

Study groups in NCT00884962
Study groupRoleWhat they receive
PLVRExperimentalNot described
Receives: Device: Polymeric Lung Volume Reduction System (PLVR)

What is being measured

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

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

    Change from baseline in RV/TLC ratio at 12 and 24 weeks following treatment

    Measured: 12 and 24 weeks following treatment

Secondary outcomes (6)

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

    • Change from baseline in FEV1 (post bronchodilator) at 12 and 24 weeks following treatment

    Measured: 12 and 24 weeks following treatment

  2. Change in Forced Vital Capacity (FVC)

    Change from baseline in FVC (post bronchodilator) at 12 and 24 weeks following treatment

    Measured: 12 and 24 weeks following treatment

  3. Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco)

    Change from baseline in DLco at 12 and 24 weeks following treatment

    Measured: 12 and 24 weeks following treatment

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

    Change from baseline in MRCD score at 12 and 24 weeks

    Measured: 12 and 24 weeks following treatment

  5. Change in distance walked in six minutes

    Change from baseline at 12 and 248 weeks in 6 Minutes Walk Test (6MWT)

    Measured: 12 and 24 weeks following treatment

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

    Change from baseline in disease-specific health related quality of life assessment (SGRQ) at 12 and 24 weeks following treatment

    Measured: 12 and 24 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 posted21 Apr 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionMay 2010
  4. Study completionMay 2010

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00884962
Sponsor's protocol ID
03-C08-003PLV
Status last verified
Oct 2011
First submitted
20 Apr 2009
Last updated
21 Oct 2011
Results posted
No

Publications

  • Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.

    PubMed 33590989

  • 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 1 study testing Polymeric Lung Volume Reduction System (PLVR) in people with Advanced Emphysema, run by Aeris Therapeutics at 6 sites in Germany.

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 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: 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 6 sites in Germany. 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 phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) (time frame: 12 and 24 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 NCT00884962, which also lists 2 linked publications.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in