Pulmonary EmphysemaPhase 2NCT00205920
Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation
A Phase 2 study testing BLVR Hydrogel in people with Pulmonary Emphysema, run by Aeris Therapeutics at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine the effective dose of the Aeris BLVR System in patients with advanced emphysema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Emphysema
- What is being tested?
- BLVR Hydrogel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2005to May 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of advanced emphysema
- Age > 18 years at the time of initial presentation
- Clinically significant dyspnea (MRC Dyspnea >/= 2)
- Laboratory tests within protocol-specified ranges
- Pulmonary function tests
Who cannot join
- Alpha-1 protease inhibitor deficiency verified by a serum level of <80mg% or knowledge of PI*ZZ genotype
- Tobacco use within 16 weeks of the initial clinic visit
- Body mass index < 15 kg/m2 or > 35 kg/m2
- Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis
- Allergy to fish or pork products or sensitivity to tetracycline
- FEV1 <20% predicted with DLCO <20% predicted or homogeneous disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Escalation Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Emphysema
The purpose of this study is to determine the effective dose of the Aeris BLVR System in 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 Bronchoscopic Lung Volume Reduction (BLVR) Hydrogel 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 and efficacy of the Aeris BLVR System in patients with advanced emphysema.
- Conditions
- Pulmonary Emphysema
- Being tested
- BLVR Hydrogel
- Keywords
- emphysema, pulmonary emphysema, COPD, COLD, chronic obstructive pulmonary disease
- 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 HydrogelBiological
10 mL BLVR Hydrogel
| Study group | Role | What they receive |
|---|---|---|
| single | Experimental | BLVR Treatment Receives: Biological: BLVR Hydrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Include: Product-related life-threatening adverse events, permanently disabling complications and deaths
Measured: 1 year post treatment
FEV1
Measured: 12 weeks post treatment
MRC Dyspnea Score
Measured: 12 weeks post treatment
Six-Minute Walk Test
Measured: 12 week post treatment
Health-Related Quality of Life
Measured: 12 week post treatment
Secondary outcomes (2)
Include: Lung function tests
Measured: 12 week post treatment
Lung volume measurements
Measured: 12 week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionSep 2006
- Study completionMay 2007
Why it stopped: Change in formulation
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeris Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- V.A.M. Duurkens, MD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205920
- Sponsor's protocol ID
- C04-012
- Status last verified
- Jan 2010
- First submitted
- 13 Sep 2005
- Last updated
- 18 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Emphysema
- ClinicalTrials.gov ID
- NCT00205920
- Acronym / sponsor ID
- C04-012
- Conditions
- Pulmonary Emphysema
- Keywords
- emphysema, pulmonary emphysema, COPD, COLD, chronic obstructive pulmonary disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in formulation
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Aeris TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 21 Sep 2005 (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 determine the effective dose of the Aeris BLVR System in 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 Bronchoscopic Lung Volume Reduction (BLVR) Hydrogel 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 and efficacy of the Aeris 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 | Experimental | Biological: BLVR HydrogelBLVR Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of advanced emphysema
- Age > 18 years at the time of initial presentation
- Clinically significant dyspnea (MRC Dyspnea >/= 2)
- Laboratory tests within protocol-specified ranges
- Pulmonary function tests
Key exclusion criteria (6 listed)
- Alpha-1 protease inhibitor deficiency verified by a serum level of <80mg% or knowledge of PI*ZZ genotype
- Tobacco use within 16 weeks of the initial clinic visit
- Body mass index < 15 kg/m2 or > 35 kg/m2
- Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis
- Allergy to fish or pork products 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 Hydrogel10 mL BLVR Hydrogel | Biological | single |
Primary outcome
Include: Product-related life-threatening adverse events, permanently disabling complications and deaths
Time frame: 1 year post treatment
FEV1
Time frame: 12 weeks post treatment
MRC Dyspnea Score
Time frame: 12 weeks post treatment
Six-Minute Walk Test
Time frame: 12 week post treatment
Health-Related Quality of Life
Time frame: 12 week post treatment
2 secondary outcomes
Include: Lung function tests
Time frame: 12 week post treatment
Lung volume measurements
Time frame: 12 week post treatment
Results and safety
The study was stopped early (reason given: Change in formulation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2010.
- 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. Epub 2002 Oct 11.Link 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.
V.A.M. Duurkens, MD principal investigator
St. Antonius Hospital
1 site 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 Hydrogel in people with Pulmonary Emphysema, run by Aeris Therapeutics at 1 site in Netherlands.
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: stopped early, as of the sponsor's last update on 18 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 was stopped early (reason given: Change in formulation). 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?
Include: Product-related life-threatening adverse events, permanently disabling complications and deaths (time frame: 1 year post treatment). The study lists 5 primary outcomes in all. 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 18 Jan 2010.