Pulmonary EmphysemaPhase 4CV+/-NCT01520740
Collateral Ventilation Effects on Response to AeriSeal System Treatment in Upper Lobe Predominant Emphysema
A Phase 4 study testing Emphysematous Lung Sealant in people with Pulmonary Emphysema, run by Aeris Therapeutics at 13 sites in 2 countries.
Trial summary
This study will evaluate the effects of baseline collateral ventilation status on outcomes following treatment with AeriSeal System in patients with advanced upper-lobe predominant heterogenous emphysema. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Emphysema
- What is being tested?
- Emphysematous Lung Sealant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Feb 2012to Nov 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 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 upper lobe predominant emphysema by CT scan
- Two (2) subsegments appropriate for treatment based upon CT scan in 2 different upper lobe segments in each lung (total 4 available subsegments)
- 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):
- TLC > 100% predicted
- RV > 150% predicted
- DLco > or = 20 and < or = 60% 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, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
- 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
- α-1 antitrypsin serum level of <80 mg/dl (immunodiffusion) or <11µmol/L (nephelometry) at Screening visit in the absence of enzyme replacement therapy. Patients with documented α-1 antitrypsin deficiency requiring replacement therapy are excluded from the study participation.
- Pulmonary hypertension, defined as:
- Echocardiogram with estimated peak systolic pressure > 45 mmHg in the presence of tricuspid valve regurgitation stated in the echocardiogram report
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- 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
- 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 diameter)
- 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) and investigational medications within 4 weeks of screening
- 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 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
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Germany10 sites
Zentralklinik Bad Berka GmbH
Bad Berka, 99437
Charite Campus Virchow-Klinikum
Berlin, 10117
Klinikum Coburg
Coburg, 96450
Klinikum Donaustauf
Donaustauf, 93093
Asklepios Fachkliniken Muenchen - Gauting
Gauting, 82131
Universitatsklinikum Halle
Halle, 06120
Asklepios Klinik Hamburg-Harburg
Hamburg, 21075
Thoraxklinik am Uniklinikum Heidelberg
Heidelberg, D-69126
Sana Kliniken Luebeck
Lübeck, 23560
Medizinische Klinik und Poliklinik Grosshadern
München, 81377
Israel3 sites
Hadassah - Hebrew University Medical Center
Jerusalem, 91120
Carmel Medical Center
Petah Tikva, 49100
Chaim Sheba Medical Center
Tel Aviv, 52621
About this study
This study will evaluate the effects of baseline collateral ventilation status on outcomes following treatment with AeriSeal System in patients with advanced upper-lobe predominant heterogenous emphysema.
- Conditions
- Pulmonary Emphysema
- Being tested
- Emphysematous Lung Sealant
- Keywords
- Gold Stage III, Gold Stage IV, Chronic Obstructive Pulmonary Disease, COPD, Lung Volume Reduction Surgery, LVRS, Bronchoscopic Lung Volume Reduction, BLVR, Upper Lobe Predominant, ULP, Heterogeneous, Homogeneous
- Medical subject headings
- Pulmonary Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emphysematous Lung SealantDevice
Also called AeriSeal System Treatment
4 Subsegments treated - 2 each bilaterally
Emphysematous Lung SealantDevice
Also called AeriSeal System Treatment
4 Subsegments treated - 2 each bilaterally
| Study group | Role | What they receive |
|---|---|---|
| Collateral Ventilation Positive (CV+) | Active comparator | Not described Receives: Device: Emphysematous Lung Sealant |
| Collateral Ventilation Negative (CV-) | Active comparator | Not described Receives: Device: Emphysematous Lung Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in group mean post bronchodilator Forced Exhalation Volume in one second (FEV1)
Measured: 24 Weeks
Secondary outcomes (2)
Change from Baseline in group mean 6 Minute Walk Test (6MWT) distance
Measured: 24 Weeks
Change from baseline in group mean health related quality of life
Change from baseline in group mean health related quality of life, measured in terms of St. George's Respiratory Questionnaire (SGRQ) total domain score
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aeris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janine McDermott, MS CCRP, Study director, Aeris Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520740
- Sponsor's protocol ID
- 03-C11-004PLV
- Acronym
- CV+/-
- Status last verified
- Nov 2013
- First submitted
- 26 Jan 2012
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
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
- Collateral Ventilation Effects on Response to AeriSeal System Treatment in Upper Lobe Predominant Emphysema
- ClinicalTrials.gov ID
- NCT01520740
- Acronym / sponsor ID
- CV+/- / 03-C11-004PLV
- Conditions
- Pulmonary Emphysema
- Keywords
- Gold Stage III, Gold Stage IV, Chronic Obstructive Pulmonary Disease, COPD, Lung Volume Reduction Surgery, LVRS, Bronchoscopic Lung Volume Reduction, BLVR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aeris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 30 Jan 2012 (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.
This study will evaluate the effects of baseline collateral ventilation status on outcomes following treatment with AeriSeal System in patients with advanced upper-lobe predominant heterogenous emphysema.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collateral Ventilation Positive (CV+) | Active comparator | Device: Emphysematous Lung Sealant |
| Collateral Ventilation Negative (CV-) | Active comparator | Device: Emphysematous Lung Sealant |
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 upper lobe predominant emphysema by CT scan
- Two (2) subsegments appropriate for treatment based upon CT scan in 2 different upper lobe segments in each lung (total 4 available subsegments)
- MRCD questionnaire score of 2 or greater at screening
Key exclusion criteria (26 listed)
- 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
- 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
- α-1 antitrypsin serum level of <80 mg/dl (immunodiffusion) or <11µmol/L (nephelometry) at Screening visit in the absence of enzyme replacement therapy. Patients with documented α-1 antitrypsin deficiency requiring replacement therapy are excluded from the study participation.
- Pulmonary hypertension, defined as:
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 |
|---|---|---|
| Emphysematous Lung SealantAlso: AeriSeal System Treatment4 Subsegments treated - 2 each bilaterally | Device | Collateral Ventilation Positive (CV+) |
| Emphysematous Lung SealantAlso: AeriSeal System Treatment4 Subsegments treated - 2 each bilaterally | Device | Collateral Ventilation Negative (CV-) |
Primary outcome
Change from baseline in group mean post bronchodilator Forced Exhalation Volume in one second (FEV1)
Time frame: 24 Weeks
2 secondary outcomes
Change from Baseline in group mean 6 Minute Walk Test (6MWT) distance
Time frame: 24 Weeks
Change from baseline in group mean health related quality of life
Time frame: 24 Weeks
Results and safety
The study was stopped early. Results are not available in the source record.
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.
Janine McDermott, MS CCRP study director
Aeris Therapeutics
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Emphysematous Lung Sealant in people with Pulmonary Emphysema, run by Aeris Therapeutics at 13 sites in 2 countries.
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 26 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 13 sites in Germany, 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 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?
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 group mean post bronchodilator Forced Exhalation Volume in one second (FEV1) (time frame: 24 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.