Homogeneous EmphysemaPhase 2NCT00630227
Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study
A Phase 2 study testing Biologic Lung Volume Reduction in people with Homogeneous Emphysema, run by Aeris Therapeutics at 8 sites in United States.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also eligible for participation. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Homogeneous Emphysema
- What is being tested?
- Biologic Lung Volume Reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2008to Dec 2009
- Phase
- Phase 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
- clinical diagnosis of advanced homogeneous or upper lobe predominant emphysema demonstrated by CT scan
- age >/= 40 years
- clinically significant dyspnea
- failure of standard medical therapy (typically inhaled beta agonist \& inhaled anticholinergic) to relieve symptoms
- pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 < 45% predicted \& experiencing < 30% or 300 mL improvement using bronchodilator; total lung capacity > 110% predicted; residual volume > 150% predicted)
- 6 Minute Walk Distance >/= 150 m
Who cannot join
- tobacco use within 4 months of initial visit or during study
- body mass index < 15 kg/m2 or> 35 kg/m2
- clinically significant asthma, chronic bronchitis or bronchiectasis
- allergy or sensitivity to procedural components
- pregnant, lactating or unwilling to use birth control if required
- prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endotracheal valve placement, airway stent placement or pleurodesis
Show all 9Show fewer
- comorbid condition that could adversely influence outcomes
- inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
- history of renal infarction or renal failure lung perfusion scan indicating > 20% of blood flow to either upper lung field or 30% total to both upper lung fields if homogeneous emphysema
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Akron Medical Center
Akron, Ohio, 44302
University of Alabama
Birmingham, Alabama, 35249
Cleveland Clinic Foundation, Pulmonary Allergy & Critical Care Medicine
Cleveland, Ohio, 44195
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
Temple University Lung Center
Philadelphia, Pennsylvania, 19140
Pulmonary Associates
Phoenix, Arizona, 85006
Veritas Clinical Specialties
Topeka, Kansas, 66606
St Josephs Medical Center
Towson, Maryland, 21204
About this study
Official title: Phase 2 Study of the 20 mL Biologic Lung Volume Reduction (BLVR) System in Patients With Homogeneous or Upper Lobe Predominant Emphysema
The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also eligible for participation.
Read the detailed description
Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery (LVRS) involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. LVRS, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.
Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System which is intended to achieve lung volume reduction without surgery and its attendant risks. Patients are treated using a bronchoscope to direct treatment to the most damaged areas of the lung or in the case of homogeneous disease, areas that are less active as shown by the extent of regional blood flow. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a biodegradable hydrogel. The hydrogel acts to reduce lung volume by permanently collapsing and sealing the treated areas of the lung. This provides room within the chest to allow the remaining portions of the lung to function better.
Aeris' BLVR development program has been granted Fast Track designation by the U.S. FDA, and is the subject of ongoing clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous (upper lobe predominant) emphysema. Fast Track designation is reserved for drug and biologic development programs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
- Conditions
- Homogeneous Emphysema
- Being tested
- Biologic Lung Volume Reduction
- Keywords
- emphysema, chronic obstructive pulmonary disease, lung volume reduction
- 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.
Biologic Lung Volume ReductionBiological
20 mL Hydrogel
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | all patients are treated with the experimental therapy Receives: Biological: Biologic Lung Volume Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in gas trapping
Measured: 12 weeks post treatment
Secondary outcomes (6)
improvement in exercise capacity
Measured: 12 weeks post treatment
improvement in expiratory flow
Measured: 12 weeks post treatment
improvement in vital capacity
Measured: 12 weeks post treatment
improvement in dyspnea sysmptoms
Measured: 12 weeks post treatment
improvemnet in respiratory quality of life
Measured: 12 weeks post treatment
serious adverse events
Measured: through 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Homogeneous 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Gotfried, MD, Principal investigator, Pulmonary Associates, Phoenix, AZMark Dransfield, MD, Principal investigator, University of Alabama, Birmingham, ALGerard Criner, MD, Principal investigator, Temple University Lung Center, Philadelphia, PAWilliam Leeds, DO, Principal investigator, Veritas Clinical Specialties, Topeka, KSMark Krasna, MD, Principal investigator, St Josephs Medical Center, Towson, MDThomas Gildea, MD, Principal investigator, Cleveland Clinic, Cleveland, OHSanjiv Tewari, MD, Principal investigator, Akron Medical Center, Akron, OHGeoffrey McLennan, MD, Principal investigator, University of Iowa Hospitals & Clinics, Iowa City, IA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630227
- Sponsor's protocol ID
- 01-C07-002
- Status last verified
- Oct 2011
- First submitted
- 27 Feb 2008
- Last updated
- 24 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11.
PubMed 12406835Reilly J, Washko G, Pinto-Plata V, Velez E, Kenney L, Berger R, Celli B. Biological lung volume reduction: a new bronchoscopic therapy for advanced emphysema. Chest. 2007 Apr;131(4):1108-13. doi: 10.1378/chest.06-1754.
PubMed 17426216
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the 20 mL Biologic Lung Volume Reduction (BLVR) System in Patients With Homogeneous or Upper Lobe Predominant Emphysema
- ClinicalTrials.gov ID
- NCT00630227
- Acronym / sponsor ID
- 01-C07-002
- Conditions
- Homogeneous Emphysema
- Keywords
- emphysema, chronic obstructive pulmonary disease, lung volume reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Aeris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Mar 2008 (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 the study is to evaluate the efficacy and safety of the 20 mL BLVR System in patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also eligible for participation.
Detailed description
Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery (LVRS) involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. LVRS, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.
Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System which is intended to achieve lung volume reduction without surgery and its attendant risks. Patients are treated using a bronchoscope to direct treatment to the most damaged areas of the lung or in the case of homogeneous disease, areas that are less active as shown by the extent of regional blood flow. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a biodegradable hydrogel. The hydrogel acts to reduce lung volume by permanently collapsing and sealing the treated areas of the lung. This provides room within the chest to allow the remaining portions of the lung to function better.
Aeris' BLVR development program has been granted Fast Track designation by the U.S. FDA, and is the subject of ongoing clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous (upper lobe predominant) emphysema. Fast Track designation is reserved for drug and biologic development programs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Biological: Biologic Lung Volume Reductionall patients are treated with the experimental therapy |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- clinical diagnosis of advanced homogeneous or upper lobe predominant emphysema demonstrated by CT scan
- age >/= 40 years
- clinically significant dyspnea
- failure of standard medical therapy (typically inhaled beta agonist \& inhaled anticholinergic) to relieve symptoms
- pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 < 45% predicted \& experiencing < 30% or 300 mL improvement using bronchodilator; total lung capacity > 110% predicted; residual volume > 150% predicted)
Key exclusion criteria (9 listed)
- tobacco use within 4 months of initial visit or during study
- body mass index < 15 kg/m2 or> 35 kg/m2
- clinically significant asthma, chronic bronchitis or bronchiectasis
- allergy or sensitivity to procedural components
- pregnant, lactating or unwilling to use birth control if required
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 |
|---|---|---|
| Biologic Lung Volume Reduction20 mL Hydrogel | Biological | Single |
Primary outcome
reduction in gas trapping
Time frame: 12 weeks post treatment
6 secondary outcomes
improvement in exercise capacity
Time frame: 12 weeks post treatment
improvement in expiratory flow
Time frame: 12 weeks post treatment
improvement in vital capacity
Time frame: 12 weeks post treatment
improvement in dyspnea sysmptoms
Time frame: 12 weeks post treatment
improvemnet in respiratory quality of life
Time frame: 12 weeks post treatment
serious adverse events
Time frame: through 2 years
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 24 Oct 2011.
- Background: PubMed 12406835Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11.
- Background: PubMed 17426216Reilly J, Washko G, Pinto-Plata V, Velez E, Kenney L, Berger R, Celli B. Biological lung volume reduction: a new bronchoscopic therapy for advanced emphysema. Chest. 2007 Apr;131(4):1108-13. doi: 10.1378/chest.06-1754.
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.
Mark Gotfried, MD principal investigator
Pulmonary Associates, Phoenix, AZ
Mark Dransfield, MD principal investigator
University of Alabama, Birmingham, AL
Gerard Criner, MD principal investigator
Temple University Lung Center, Philadelphia, PA
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biologic Lung Volume Reduction in people with Homogeneous Emphysema, run by Aeris Therapeutics at 8 sites in United States.
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 6 inclusion and 9 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 24 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 8 sites in United States. 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 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?
reduction in gas trapping (time frame: 12 weeks post 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 NCT00630227, 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 24 Oct 2011.