EmphysemaPhase 3NCT01908933
Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema
A Phase 3 study testing AeriSeal Emphysematous Lung Sealant Syst in people with Emphysema and Chronic Obstructive Pulmonary Disease (COPD), run by Aeris Therapeutics.
Trial summary
The purpose of this study is to prospectively evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Emphysema, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- AeriSeal Emphysematous Lung Sealant Syst
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Nov 2013
- Phase
- Phase 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
- Willing and able to provide informed consent and to participate in the study
- Age > or = 40 years at the time of the screening
- Advanced lower or lower and upper lobe predominant heterogeneous emphysema by CT scan
- Minimum of 2 subsegments appropriate for treatment
- MRCD questionnaire score of 2 or greater at screening
- Failure of medical therapy to provide relief of symptoms
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- Spirometry 15 minutes after administration of bronchodilator (BOTH):
- FEV1 < 50 % predicted.
- FEV1/FVC ratio <70 %
- Lung volumes by plethysmography (BOTH):
- Total Lung Capacity (TLC) > 100 % predicted
- Residual Volume (RV) > 150 % predicted
- Diffusing Capacity of Carbon Monoxide(DLco) > = 20 and < = 60 percent predicted
- Oxygen saturation (SpO2) > 90 % on < or = 4 L/min supplemental O2, at rest
- Six-Minute Walk Test distance > or = 150 m
- Abstinence from smoking for at least 16 weeks prior to screening
Who cannot join
- Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, or prior lung transplantation
- Requirement for ventilator support (invasive or non-invasive)
- Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks of Screening visit
- Pulmonary hypertension, defined as:
- Echocardiogram with estimated peak systolic pressure > 45 mmHg in the presence of tricuspid valve regurgitation stated in the echocardiogram report
- If the echocardiogram shows peak systolic pressure > 45 mmHg, right heart catheterization is required to rule out pulmonary hypertension, defined as peak systolic pressure > 45 mmHg or mean pressure > 35 mmHg
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- Clinically significant asthma (reversible airway obstruction) or bronchiectasis
- CT scan: Presence of the following radiologic abnormalities:
- Pulmonary nodule on CT scan greater that 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)
- Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate
- Significant interstitial lung disease
- Significant pleural disease
- Giant bullous disease (a predominant bulla > 10 cm in all dimensions >1 / 3 of the hemithorax)
- 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)
- Allergy or sensitivity to medications required to safely undergo AeriSeal System treatment
- Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to the screening visit
- Body mass index < 15 kg/m2 or > 35 kg/m2
- Female patient pregnant or breast-feeding or planning to be pregnant in the next year
- Significant comorbidity that carries prohibitive risks or is associated with less than 2-year expected survival, including any of the following:
- HIV/AIDS
- Active malignancy
- Stroke or Transient Ischemia Attack (TIA) within 12 months of screening
- Myocardial infarction within 12 months of screening
- Congestive heart failure within 12 months of screening defined at clinical evidence of right or left hear failure or left ventricular ejection fraction < 45 % on echocardiogram
- 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 such as alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits
About this study
The purpose of this study is to prospectively evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
Read the detailed description
This is a prospective single arm study to evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
- Being tested
- AeriSeal Emphysematous Lung Sealant Syst
- Keywords
- Advanced Emphysema, Heterogeneous Lower Lobe Predominant Emphysema, Heterogeneous Upper and Lower Lobe Predominant
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AeriSeal Emphysematous Lung Sealant SystDevice
This is a prospective, open label, single-arm, multicenter, investigational study. Patients will receive either unilateral or bilateral AeriSeal System therapy as appropriate utilizing 20 mL/subsegment dosing at 2 to 4 subsegments.
| Study group | Role | What they receive |
|---|---|---|
| AeriSeal Emphysematous Lung Sealant Syst | Experimental | This is a prospective, open label, single-arm, multicenter, investigational study. Patients will receive either unilateral or bilateral AeriSeal System therapy as appropriate utilizing 20 mL/subsegment dosing at 2 to 4 subsegments. Receives: Device: AeriSeal Emphysematous Lung Sealant Syst |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume change by CT
Group mean normalized change from baseline in the volume of the treated lung lobes measured by quantitative CT at 24 weeks post-treatment (defined as the sum of volume change in all treated lobes/number of treatments).
Measured: 28 - 30 weeks
Secondary outcomes (1)
Fraction of patients showing clinically significant improvements from baseline in one or more of the following outcomes at 24 weeks post treatment: Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), Medical Research Council Dyspnea
Group mean change in baseline to week 24 in:Forced Expiratory Volume in 1 second (FEV1),Forced Vital Capacity (FVC),Medical Research Council Dyspnea (MRCD), 6 Six-Minute Walk Test (6MWT), Saint George Respiratory Questionnaire (SGRQ)
Measured: 28 - 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013 (estimated)
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felix Herth, Prof. Dr med, Principal investigator, Thoraxklinik am Uniklinikum HeidelbergWolfgang Gesierich, Dr med, Principal investigator, Asklepios Fachkliniken Muenchen - GautingManfred Wagner, Dr med, Principal investigator, Klinikum Nuernberg NordMordechai Kramer, Prof, Principal investigator, Rabin Medical CenterMartin Hetzel, Dr med, Principal investigator, Krankenhaus vom Roten Kreuz - Stuttgart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908933
- Sponsor's protocol ID
- 03-C13-001PLV
- Status last verified
- Nov 2013
- First submitted
- 18 Jul 2013
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the AeriSeal System Treatment in Patients With Advanced Non-Upper Lobe Predominant Heterogeneous Emphysema
- ClinicalTrials.gov ID
- NCT01908933
- Acronym / sponsor ID
- 03-C13-001PLV
- Keywords
- Advanced Emphysema, Heterogeneous Lower Lobe Predominant Emphysema, Heterogeneous Upper and Lower Lobe Predominant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aeris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to prospectively evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
Detailed description
This is a prospective single arm study to evaluate the safety and efficacy of the AeriSeal System in patients with advanced Non-Upper Lobe Predominant Heterogeneous Emphysema.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AeriSeal Emphysematous Lung Sealant Syst | Experimental | Device: AeriSeal Emphysematous Lung Sealant SystThis is a prospective, open label, single-arm, multicenter, investigational study. Patients will receive either unilateral or bilateral AeriSeal System therapy as appropriate utilizing 20 mL/subsegment dosing at 2 to 4 subsegments. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Willing and able to provide informed consent and to participate in the study
- Age > or = 40 years at the time of the screening
- Advanced lower or lower and upper lobe predominant heterogeneous emphysema by CT scan
- Minimum of 2 subsegments appropriate for treatment
- MRCD questionnaire score of 2 or greater at screening
Key exclusion criteria (25 listed)
- Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, or prior lung transplantation
- Requirement for ventilator support (invasive or non-invasive)
- Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks of Screening visit
- Pulmonary hypertension, defined as:
- Clinically significant asthma (reversible airway obstruction) or bronchiectasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AeriSeal Emphysematous Lung Sealant SystThis is a prospective, open label, single-arm, multicenter, investigational study. Patients will receive either unilateral or bilateral AeriSeal System therapy as appropriate utilizing 20 mL/subsegment dosing at 2 to 4 subsegments. | Device | AeriSeal Emphysematous Lung Sealant Syst |
Primary outcome
Volume change by CT
Time frame: 28 - 30 weeks
Group mean normalized change from baseline in the volume of the treated lung lobes measured by quantitative CT at 24 weeks post-treatment (defined as the sum of volume change in all treated lobes/number of treatments).
1 secondary outcome
Fraction of patients showing clinically significant improvements from baseline in one or more of the following outcomes at 24 weeks post treatment: Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), Medical Research Council Dyspnea
Time frame: 28 - 30 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Herth, Prof. Dr med principal investigator
Thoraxklinik am Uniklinikum Heidelberg
Wolfgang Gesierich, Dr med principal investigator
Asklepios Fachkliniken Muenchen - Gauting
Manfred Wagner, Dr med principal investigator
Klinikum Nuernberg Nord
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AeriSeal Emphysematous Lung Sealant Syst in people with Emphysema and Chronic Obstructive Pulmonary Disease (COPD), run by Aeris Therapeutics.
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 25 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: withdrawn, 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.
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 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 withdrawn before enrolling participants, so there are no results.
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?
Volume change by CT (time frame: 28 - 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.