Pulmonary EmphysemaPhase 1NCT00347659
US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study
A Phase 1 study testing BLVR System in people with Pulmonary Emphysema, run by Aeris Therapeutics at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced 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?
- BLVR System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2006to Sep 2007
- Phase
- Phase 1
- 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 heterogeneous emphysema
- Age >/= 40
- Clinically significant dyspnea
- Failure of standard medical therapy to relieve symptoms
- Pulmonary function tests with protocol-specified ranges
Who cannot join
- Alpha-1 protease inhibitor deficiency
- Tobacco use within 16 weeks of initial clinic visit
- Body mass index < 15 kg/m2 or > 35 kg/m@
- Clinically significant asthma, chronic bronchitis or bronchiectasis
- Allergy or sensitivity to tetracycline
- Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior endobronchial valve placement, prior airway stent placement or prior pleurodesis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Temple University Lung Center
Philadelphia, Pennsylvania, 19140
About this study
Official title: Phase 1 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.
Read the detailed description
Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.
Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Biologic Lung Volume Reduction (BLVR) System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. This study will evaluate the safety of the BLVR System in patients with advanced emphysema.
- Conditions
- Pulmonary Emphysema
- Being tested
- BLVR System
- Keywords
- Lung volume reduction, Bronchoscopy, Emphysema, COPD, NETT, Lung disease, COLD, BLVR
- Medical subject headings
- Pulmonary Emphysema, Emphysema, Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLVR SystemDrug
Treatment is administered in a single treatment session.
| Study group | Role | What they receive |
|---|---|---|
| Single Treatment | Experimental | Experimental Treatment Receives: Drug: BLVR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAEs - Safety of the procedure from initiation of treatment through hospital discharge.
Measured: 1 week post treatment
SAEs - Safety of the treatment through Week 12.
Measured: 12 weeks post procedure
Secondary outcomes (7)
SAEs - Safety of the treatment through Week 48.
Measured: 48 weeks post treatment
Evaluation of radiologic changes.
Measured: 12 weeks post treatment
Improvement in exercise capacity.
Measured: 12 weeks post treatment
Improvement in quality of life.
Measured: 12 weeks post treatment
Decrease in trapped gas.
Measured: 12 weeks post treatment
Improvement in lung function.
Measured: 12 weeks post trreatment
Improvement in symptoms.
Measured: 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionDec 2006
- Study completionSep 2007
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 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00347659
- Sponsor's protocol ID
- 01-C06-001
- Status last verified
- Feb 2008
- First submitted
- 30 Jun 2006
- Last updated
- 6 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
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 12406835
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
- ClinicalTrials.gov ID
- NCT00347659
- Acronym / sponsor ID
- 01-C06-001
- Conditions
- Pulmonary Emphysema
- Keywords
- Lung volume reduction, Bronchoscopy, Emphysema, COPD, NETT, Lung disease, COLD, BLVR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Aeris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 4 Jul 2006 (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 of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.
Detailed description
Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.
Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Biologic Lung Volume Reduction (BLVR) System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. This study will evaluate the safety of the BLVR System in patients with advanced emphysema.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Treatment | Experimental | Drug: BLVR SystemExperimental Treatment |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of advanced heterogeneous emphysema
- Age >/= 40
- Clinically significant dyspnea
- Failure of standard medical therapy to relieve symptoms
- Pulmonary function tests with protocol-specified ranges
Key exclusion criteria (6 listed)
- Alpha-1 protease inhibitor deficiency
- Tobacco use within 16 weeks of initial clinic visit
- Body mass index < 15 kg/m2 or > 35 kg/m@
- Clinically significant asthma, chronic bronchitis or bronchiectasis
- Allergy or sensitivity to tetracycline
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 |
|---|---|---|
| BLVR SystemTreatment is administered in a single treatment session. | Drug | Single Treatment |
Primary outcome
SAEs - Safety of the procedure from initiation of treatment through hospital discharge.
Time frame: 1 week post treatment
SAEs - Safety of the treatment through Week 12.
Time frame: 12 weeks post procedure
7 secondary outcomes
SAEs - Safety of the treatment through Week 48.
Time frame: 48 weeks post treatment
Evaluation of radiologic changes.
Time frame: 12 weeks post treatment
Improvement in exercise capacity.
Time frame: 12 weeks post treatment
Improvement in quality of life.
Time frame: 12 weeks post treatment
Decrease in trapped gas.
Time frame: 12 weeks post treatment
Improvement in lung function.
Time frame: 12 weeks post trreatment
Improvement in symptoms.
Time frame: 12 weeks post 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 6 Mar 2008.
- 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.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BLVR System in people with Pulmonary Emphysema, run by Aeris Therapeutics at 2 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 5 inclusion and 6 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 6 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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.
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?
SAEs - Safety of the procedure from initiation of treatment through hospital discharge. (time frame: 1 week post treatment). The study lists 2 primary outcomes in all. 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 NCT00347659, 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 6 Mar 2008.