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Pulmonary EmphysemaPhase 4CV+NCT01460108

AeriSeal System in Patients With Advanced Upper Lobe Predominant Emphysema and Collateral Ventilation

A Phase 4 study testing AeriSeal System in people with Pulmonary Emphysema and COPD, run by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to characterize the safety and efficacy of the AeriSeal System in patients with advanced upper lobe predominant emphysema and significant collateral ventilation as determined by the Chartis System. Read more about this study

Who is it for?
Any age
Conditions the study is for
Pulmonary Emphysema, COPD, Lung Diseases
What is being tested?
AeriSeal System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteAustria
Study dates
Apr 2011to Jun 2013
Phase
Phase 4
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Willing and able to provide informed consent and to participate in the study
  • Diagnosis of advanced emphysema (GOLD Stage III or Stage IV disease)
  • Radiologic evidence of non-bullous upper lobe predominant heterogeneous emphysema with at least 2 target sites deemed appropriate for treatment evident by CT imaging
  • DLco between 20 and 60% predicted
  • Positive Collateral Ventilation as determined by the Chartis® System
  • Clinically significant dyspnea (defined as a MRC dyspnea score of 2 or greater at Screening)
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  • Failure of standard medical therapy to provide adequate relief of symptoms (defined as regular use of standard medication for more than 1 month prior to Screening; standard medications include at least an inhaled beta agonist and inhaled anticholinergic unless medically contraindicated or prior medical failure)
  • Significant airflow obstruction as demonstrated by Spirometry 15 minutes after administration of bronchodilator with:
  • 5% < FEV1 < 50% predicted using the ATS recommended calculation for expected value
  • FEV1/FVC ratio <70%
  • Physiological evidence of hyperinflation with Lung volumes (plethysmographic) of:
  • TLC > 100% predicted using the ATS recommended calculation for expected value
  • RV > 135% predicted using the ATS recommended calculation for expected value
  • Six-Minute Walk Test distance ≥ 150 m
  • Abstinence from inhaled tobacco use for at least 16 weeks prior to the initial Screening visit until the end of the study
  • Female patients are either post-menopausal or surgically sterile. Women with child-bearing potential will not be included in this study

Who cannot join

  • Alpha-1 antitrypsin serum level of < 80 mg/dL (i.e. < 11 micro mol/L) at Screening
  • Body mass index < 15 kg/m2 or > 35 kg/m
  • Clinically significant asthma, chronic bronchitis or bronchiectasis as determined by the Investigator, or a significant COPD exacerbation within the past 4 months
  • Use of systemic steroids > 20 mg/day or equivalent immunosuppressive agents, heparins, oral anticoagulants (e.g., warfarin, dicumarol; note: antiplatelet drugs including aspirin and clopidogrel are permitted) or investigational medications within 4 weeks of Screening
  • Allergy or sensitivity to medications required to safely perform AeriSeal System treatment under general anesthesia or conscious sedation
  • Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the Screening visit
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  • Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
  • Significant co-morbidity that carries prohibitive risks (e.g., HIV/AIDS, cancer) or is associated with less than 2-year expected survival
  • Blood gases and oxygen saturation:
  • SpO2 ≤ 90% on > 4 L/min supplemental O2, at rest
  • PaCO2 ≥ 55mmHg
  • DLCO < 20% or > 60% predicted for patients with heterogeneous emphysema
  • Chest CT scan: Presence of any of the following radiologic abnormalities:
  • Pulmonary nodule on CT scan greater than 1.0 cm in diameter (Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/PET)
  • Giant Bullous Disease
  • Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate
  • Significant interstitial lung disease (based upon investigator judgment)
  • Significant pleural disease (based upon investigator judgment)
  • Any condition that the Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient

Trial locations and contacts

1 site in 1 country.

Arschang Valipour, MD, FCCP contact

43-1-91060-41008

arschang.valipour@wienkav.at

Austria1 site, 1 recruiting

  • Otto-Wagner-Spital

    Vienna, 1140

    Arschang Valipour, MD, FCCP, 43-1-91060-41008, arschang.valipour@wienkav.at

    Arschang Valipour, MD, FCCP

    Recruiting

Other trials in Austria

About this study

Official title: Utility of the AeriSeal System in Patients With Advanced Upper Lobe Predominant Emphysema and Collateral Ventilation Assessed by the Chartis System

The purpose of this study is to characterize the safety and efficacy of the AeriSeal System in patients with advanced upper lobe predominant emphysema and significant collateral ventilation as determined by the Chartis System.

Read the detailed description

This is an investigator initiated, open-label, uncontrolled study to prospectively characterize the safety and efficacy of the AeriSeal System in patients with advanced upper lobe predominant emphysema found to have significant collateral ventilation using the Chartis System.

Being tested
AeriSeal System
Keywords
PLVR, AeriSeal, Treatment, Device, Breathing, COPD, emphysema, polymeric lung volume reduction, heterogeneous, homogeneous, Chronic Obstructive Pulmonary Disease
Medical subject headings
Pulmonary Emphysema, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiratory Aspiration, Emphysema

What participants receive

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

  • AeriSeal SystemDevice

    Also called Emphasemateous Lung Sealant

    20 mL

Study groups in NCT01460108
Study groupRoleWhat they receive
AeriSeal System TreatmentExperimentalCandidates for the trial include patients with advanced non-bullous upper lobe predominant emphysema who have a DLco between 20 and 60% predicted and target sites in at least 1 upper lobe. Eligible and consented patients will undergo evaluation with the Chartis System, and only patients found to have significant collateral ventilation will be enrolled.
Receives: Device: AeriSeal System

What is being measured

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

  1. Change in Forced Expiratory Volume in one second (FEV1)

    Change from baseline in FEV1 measurement after 12 weeks following completion of therapy.

    Measured: 12 Weeks

Secondary outcomes (8)

  1. Change in Forced Expiratory Volume in one second (FEV1).

    Change from baseline in FEV1 at 24 Weeks following completion of therapy

    Measured: 24 Weeks

  2. Change in Forced Vital Capacity (FVC)

    Change from baseline in FVC at 12 and 24 weeks following completion of therapy.

    Measured: 12 Weeks and 24 Weeks

  3. Change in ratio of Residual Volume to Total Lung Capacity (RV/TLC)

    Change from baseline in RV/TLC ratio at 24 weeks following completion of therapy.

    Measured: 24 Weeks

  4. Change in distance walked in six minutes (6MWT)

    Change from baseline in 6MWT distance at 24 weeks following completion of therapy.

    Measured: 24 Weeks

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

    Change from baseline in MRCD score at 24 weeks following completion of therapy

    Measured: 24 Weeks

  6. Change in health related quality of life assessment (St. George's Respiratory Questionnaire)(SGRQ)

    Change from baseline in disease-specific health related quality of life assessment (SGRQ) at 24 weeks following completion of therapy.

    Measured: 24 Weeks

  7. Change in Collateral Ventilation

    Change from baseline in collateral ventilation at 24 weeks following completion of therapy as measured by the Chartis System.

    Measured: 24 Weeks

  8. Unanticipated Serious Adverse Device Effects (USADEs)

    Record of any/all USADEs up to 24 weeks follwoing completion of therapy.

    Measured: 24 Week

Timeline

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

  1. First posted26 Oct 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionDec 2012 (estimated)
  4. Study completionJun 2013 (estimated)

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01460108
Sponsor's protocol ID
EK_11_027_0311
Acronym
CV+
Status last verified
Oct 2011
First submitted
25 Oct 2011
Last updated
27 Oct 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing AeriSeal System in people with Pulmonary Emphysema and COPD, run by LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology at 1 site in Austria.

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 16 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 27 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 1 site in Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Arschang Valipour, MD, FCCP (43-1-91060-41008, arschang.valipour@wienkav.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Forced Expiratory Volume in one second (FEV1) (time frame: 12 Weeks). 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 NCT01460108.

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 27 Oct 2011.

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