EmphysemaPhase 1/2NCT01051258
AeriSeal System for Lung Volume Reduction
A Phase 1/2 study testing AeriSeal System in people with Emphysema and Chronic Obstructive Pulmonary Disease (COPD), run by Aeris Therapeutics at 8 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced 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), Pulmonary Emphysema
- What is being tested?
- AeriSeal System
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Nov 2009to Apr 2013
- Phase
- Phase 1/2
- 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 emphysema as defined by FEV1/FVC<70% predicted, FEV1 of <50% predicted, TLC > 100% 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 prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.
Who cannot join
None listed.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Germany4 sites
Chefarzt Klinik für Pneumologie
Bad Berka
Thoraxklinik Heidelberg
Heidelberg
Lungenklinik Hemer
Hemer
Medizinische Klinik und Poliklinik Klinikum Großhadern
München
Israel2 sites
Soroka Medical Center
Beersheba
Rabin Medical Center, Beilinson Hospital
Petah Tikva
France1 site
Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice
Nice
About this study
Official title: A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema
The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.
Read the detailed description
The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced homogeneous and heterogeneous emphysema.
- Conditions
- Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Emphysema, Lung Diseases
- Being tested
- AeriSeal System
- Keywords
- Polymeric Lung Volume Reduction (PLVR), Biologic 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
- Emphysema, Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema, Lung Diseases, Respiratory Aspiration, 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
Also called lung volume reduction, AeriSeal, PLVR
AeriSeal System for Lung Volume Reduction
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio
Measured: 12 Weeks following final treatment
Secondary outcomes (5)
Change from baseline in RV/TLC ratio
Measured: 24 and 48 weeks following treatment
Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator)
Measured: 12, 24, 48 weeks following treatment
Change from baseline in MRC dyspnea score
Measured: 12, 24, 48 weeks following treatment
Change from baseline in 6 minute walk test (MWT)
Measured: 12, 24, 48 weeks following treatment
Change from baseline in disease-specific health related quality of life assessment (SGRQ)
Measured: 12, 24, 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.
- First posted18 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionAug 2011
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051258
- Sponsor's protocol ID
- 03-C08-003PLVGP4-5
- Other IDs
- 03-C10-001PLV
- Status last verified
- Jun 2013
- First submitted
- 14 Jan 2010
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema
- ClinicalTrials.gov ID
- NCT01051258
- Acronym / sponsor ID
- 03-C08-003PLVGP4-5
- Conditions
- Emphysema, Chronic Obstructive Pulmonary Disease (COPD), Pulmonary Emphysema, Lung Diseases
- Keywords
- Polymeric Lung Volume Reduction (PLVR), Biologic Lung Volume Reduction (BLVR), AeriSeal, treatment, device, breathing, COPD, emphysema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Aeris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Jan 2010 (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 evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced homogeneous and heterogeneous emphysema.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC<70% predicted, FEV1 of <50% predicted, TLC > 100% 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 prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.
Key exclusion criteria (0 listed)
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 SystemAlso: lung volume reduction, AeriSeal, PLVRAeriSeal System for Lung Volume Reduction | Device | – |
Primary outcome
Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio
Time frame: 12 Weeks following final treatment
5 secondary outcomes
Change from baseline in RV/TLC ratio
Time frame: 24 and 48 weeks following treatment
Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator)
Time frame: 12, 24, 48 weeks following treatment
Change from baseline in MRC dyspnea score
Time frame: 12, 24, 48 weeks following treatment
Change from baseline in 6 minute walk test (MWT)
Time frame: 12, 24, 48 weeks following treatment
Change from baseline in disease-specific health related quality of life assessment (SGRQ)
Time frame: 12, 24, 48 weeks following treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
- Derived from this study: PubMed 22374920Magnussen 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.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AeriSeal System in people with Emphysema and Chronic Obstructive Pulmonary Disease (COPD), run by Aeris Therapeutics at 8 sites in 4 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 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 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Israel, Austria, France. 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 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 from baseline in respiratory volume/total lung capacity (RV/TLC) ratio (time frame: 12 Weeks following final 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 NCT01051258, which also lists 1 linked publication.
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 26 Jun 2013.