Pulmonary EmphysemaPhase 2NCT00435253
US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study
A Phase 2 study testing BLVR Treatment in people with Pulmonary Emphysema, run by Aeris Therapeutics at 5 sites in United States.
Trial summary
Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant 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 Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2007to Jun 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 upper lobe predominant emphysema
- age >/= 40 years
- clinically significant dyspnea
- failure of standard medical therapy to relieve symptoms (inhaled beta agonist and inhaled anticholinergic)
- pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 < 45% predicted and experiencing < 30% or 300 mL improvement using bronchodilator; TLC > 110% predicted; RV > 150% predicted)
- 6 Minute Walk Distance >/= 150 m
Who cannot join
- alpha-1 protease inhibitor deficiency
- homogeneous disease
- tobacco use within 4 months of initial visit
- body mass index < 15 kg/m2 or > 35 kg/m2
- clinically significant asthma, chronic bronchitis or bronchiectasis
- allergy or sensitivity to procedural components
Show all 10Show fewer
- pregnant, lactating or unwilling to use birth control if required
- prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endobronchial valve placement, airway stent placement or pleurodesis
- comorbid condition that could adversely influence outcomes
- inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama Birmingham Lung Health Center
Birmingham, Alabama, 35249
Caritas St Elizabeth's Med Cen
Boston, Massachusetts, 02135
Medical University of South Carolina Hospital
Charleston, South Carolina, 29425
Temple University Lung Center
Philadelphia, Pennsylvania, 01940
Pulmonary Associates
Phoenix, Arizona, 85006
About this study
Official title: Phase 2 Study of the Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema
Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.
Read the detailed description
Prospective, open-label, non-controlled, multi-center Phase 2 Study evaluating the efficacy and safety of the 10 mL BLVR System in patients with advanced upper lobe predominant emphysema. Twenty patients will be divided into 2 groups of 10 patients each and treated under conscious sedation at a total of 8 subsegments. Group 1 will be treated in 4 subsegments in 1 lung and have a second treatment of 4 subsegments in the other lung 6 to 12 weeks later. Group 2 will receive treatment at 8 subsegments (4 in each lung) during a single treatment session if possible; if not completed in 1 session the remaining subsegments will be treated 6 to 12 weeks later. Patients will be followed 96 weeks after completion of the final BLVR treatment. All patients will receive standard medical therapy in addition to BLVR treatment.
- Conditions
- Pulmonary Emphysema
- Being tested
- BLVR Treatment
- Keywords
- emphysema, COPD, lung volume reduction, NETT, BLVR, biologic lung volume reduction, bronchoscopic lung volume reduction
- Medical subject headings
- Pulmonary Emphysema, Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLVR TreatmentBiological
BLVR Treatment, 10 mL Hydrogel
| Study group | Role | What they receive |
|---|---|---|
| BLVR Treatment | Experimental | BLVR Treatment Receives: Biological: BLVR Treatment |
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
SAEs - Safety of treatment and the procedure
Measured: 2 years
Secondary outcomes (6)
Improvement in vital capacity
Measured: 12 weeks post treatment
Improvement in expiratory flow
Measured: 12 weeks post treatment
Improvement in inspiratory flow
Measured: 12 weeks post treatment
Improvement in dyspnea symptoms (breathlessness)
Measured: 12 weeks post treatment
Improvement in exercise capacity
Measured: 12 weeks post treatment
Improvement in respiratory quality of life
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 posted14 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victor Pinto-Plata, MD, Principal investigator, Steward St. Elizabeth's Medical Center of Boston, Inc.Gerard Criner, MD, Principal investigator, Temple University Lung CenterMark Gotfried, MD, Principal investigator, Pulmonary AssociatesCharlie Strange, MD, Principal investigator, Medical Univ South Carolina HospitalMark Dransfield, MD, Principal investigator, Univ of Alabama Birmingham Lung Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435253
- Sponsor's protocol ID
- 01-C06-003
- Status last verified
- Oct 2011
- First submitted
- 7 Feb 2007
- Last updated
- 24 Oct 2011
- 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 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 17426216Criner GJ, Pinto-Plata V, Strange C, Dransfield M, Gotfried M, Leeds W, McLennan G, Refaely Y, Tewari S, Krasna M, Celli B. Biologic lung volume reduction in advanced upper lobe emphysema: phase 2 results. Am J Respir Crit Care Med. 2009 May 1;179(9):791-8. doi: 10.1164/rccm.200810-1639OC. Epub 2009 Jan 29.
PubMed 19179484
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 Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema
- ClinicalTrials.gov ID
- NCT00435253
- Acronym / sponsor ID
- 01-C06-003
- Conditions
- Pulmonary Emphysema
- Keywords
- emphysema, COPD, lung volume reduction, NETT, BLVR, biologic lung volume reduction, bronchoscopic lung volume reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aeris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Feb 2007 (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.
Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.
Detailed description
Prospective, open-label, non-controlled, multi-center Phase 2 Study evaluating the efficacy and safety of the 10 mL BLVR System in patients with advanced upper lobe predominant emphysema. Twenty patients will be divided into 2 groups of 10 patients each and treated under conscious sedation at a total of 8 subsegments. Group 1 will be treated in 4 subsegments in 1 lung and have a second treatment of 4 subsegments in the other lung 6 to 12 weeks later. Group 2 will receive treatment at 8 subsegments (4 in each lung) during a single treatment session if possible; if not completed in 1 session the remaining subsegments will be treated 6 to 12 weeks later. Patients will be followed 96 weeks after completion of the final BLVR treatment. All patients will receive standard medical therapy in addition to BLVR treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BLVR Treatment | Experimental | Biological: BLVR TreatmentBLVR Treatment |
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 upper lobe predominant emphysema
- age >/= 40 years
- clinically significant dyspnea
- failure of standard medical therapy to relieve symptoms (inhaled beta agonist and inhaled anticholinergic)
- pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 < 45% predicted and experiencing < 30% or 300 mL improvement using bronchodilator; TLC > 110% predicted; RV > 150% predicted)
Key exclusion criteria (10 listed)
- alpha-1 protease inhibitor deficiency
- homogeneous disease
- tobacco use within 4 months of initial visit
- body mass index < 15 kg/m2 or > 35 kg/m2
- clinically significant asthma, chronic bronchitis 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 |
|---|---|---|
| BLVR TreatmentBLVR Treatment, 10 mL Hydrogel | Biological | BLVR Treatment |
Primary outcome
Reduction in gas trapping
Time frame: 12 weeks post treatment
SAEs - Safety of treatment and the procedure
Time frame: 2 years
6 secondary outcomes
Improvement in vital capacity
Time frame: 12 weeks post treatment
Improvement in expiratory flow
Time frame: 12 weeks post treatment
Improvement in inspiratory flow
Time frame: 12 weeks post treatment
Improvement in dyspnea symptoms (breathlessness)
Time frame: 12 weeks post treatment
Improvement in exercise capacity
Time frame: 12 weeks post treatment
Improvement in respiratory quality of life
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 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.
- Derived from this study: PubMed 19179484Criner GJ, Pinto-Plata V, Strange C, Dransfield M, Gotfried M, Leeds W, McLennan G, Refaely Y, Tewari S, Krasna M, Celli B. Biologic lung volume reduction in advanced upper lobe emphysema: phase 2 results. Am J Respir Crit Care Med. 2009 May 1;179(9):791-8. doi: 10.1164/rccm.200810-1639OC. Epub 2009 Jan 29.
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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.
Victor Pinto-Plata, MD principal investigator
Steward St. Elizabeth's Medical Center of Boston, Inc.
Gerard Criner, MD principal investigator
Temple University Lung Center
Mark Gotfried, MD principal investigator
Pulmonary Associates
5 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 BLVR Treatment in people with Pulmonary Emphysema, run by Aeris Therapeutics at 5 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 10 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 5 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). 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 NCT00435253, which also lists 3 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.