Alpha-1-Antitrypsin DeficiencyLuReCAANCT02273349
Lung Volume Reduction Coils for Emphysema in Alpha-1 Antitrypsin Deficiency
A study testing Lung Volume Reduction Coil (PneumrX Inc.) in people with Alpha-1-Antitrypsin Deficiency and Chronic Obstructive Lung Disease, run by University Hospital, Saarland at 2 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of the RePneu Lung Volume Reduction Coil (LVRC) in patients with Alpha-1-Antitrypsin deficiency (AATD) caused emphysema. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Alpha-1-Antitrypsin Deficiency, Chronic Obstructive Lung Disease, Emphysema
- What is being tested?
- Lung Volume Reduction Coil (PneumrX Inc.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2014to Oct 2015
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient > 18 years of age, diagnosed with AATD emphysema
- CT scan indicates bilateral heterogeneous or non-severe homogeneous emphysema, with sufficient lung parenchyma for coil deployment, in accordance with manufacturer recommendations (see section 5.2.4.1).
- Patient has post- bronchodilator FEV1 less than or equal to 45% predicted
- Total Lung Capacity > 100%
- Residual Volume (RV) >175% predicted
- Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
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- Patient has read, understood and signed the Informed Consent form
- Patient is willing and able to attend all required follow-up visits
- Patient is willing and able to undergo bilateral LVRC treatment
- Patient has received Pneumococcal and Influenza vaccinations consistent with local recommendations and/or policy
Who cannot join
- Patient has a change in FEV1 > 20% post-bronchodilator.
- Patients DLCO < 20% predicted
- Patient has a history of recurrent clinically significant respiratory infection
- Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure >50mmHg and or evidenced by echocardiogram
- Patient has an inability to walk >140 meters (150 yards) in 6 minutes
- Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc.
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- Patient is pregnant or lactating
- Patient has an inability to tolerate bronchoscopy under moderate sedation or anesthesia
- Patient has clinically significant bronchiectasis
- Patient has giant bullae > 1/3 lung volume
- Patient has had previous LVR surgery, lung transplant or lobectomy
- Patient has been involved in other pulmonary drug or device studies with 30 days prior to this study
- Patient is taking > 20mg prednisone (or similar steroid) daily
- Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as heparin or coumadin) or has not been weaned off prior to procedure
- Patient has other condition that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
- Patient has severe homogeneous emphysema by CT scan.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema in Alpha-1 Antitrypsin Deficient Patients
The objective of this study is to evaluate the safety and effectiveness of the RePneu Lung Volume Reduction Coil (LVRC) in patients with Alpha-1-Antitrypsin deficiency (AATD) caused emphysema. The hypothesis is that emphysema in AATD patients shows similar tissue destruction profile was well as symptoms and thus will respond favorably to LVRC treatment, demonstrating improvement in lung function, exercise capacity, and quality of life relative to their baseline status.
- Being tested
- Lung Volume Reduction Coil (PneumrX Inc.)
- Medical subject headings
- alpha 1-Antitrypsin Deficiency, Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Volume Reduction Coil (PneumrX Inc.)Device
Endoscopic Lung Volume Reduction
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients with Alpha-1-Antitrypsin deficiency treated with endoscopic lung volume reduction using Lung Volume Reduction Coils (PneumRx Inc.) Receives: Device: Lung Volume Reduction Coil (PneumrX Inc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) compared to the 6 months Follow-up Visit
Quality of Life
Measured: 6 months
Secondary outcomes (4)
Percent change in FEV1 from Baseline (Pre-Treatment Visit)
Lung function
Measured: 6 and 12 months
Decrease in the Residual Volume and the RV/TLC ratio
Lung function
Measured: 6 and 12 months
Improvement in the 6 minute walk distance
6MWT
Measured: 6 and 12 months
Changes in mMRC Dyspnoe Scale
mMRC
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alpha-1-Antitrypsin DeficiencyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273349
- Sponsor's protocol ID
- PL001-AATD
- Acronym
- LuReCAA
- Status last verified
- May 2017
- First submitted
- 21 Oct 2014
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema in Alpha-1 Antitrypsin Deficient Patients
- ClinicalTrials.gov ID
- NCT02273349
- Acronym / sponsor ID
- LuReCAA / PL001-AATD
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 23 Oct 2014 (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 objective of this study is to evaluate the safety and effectiveness of the RePneu Lung Volume Reduction Coil (LVRC) in patients with Alpha-1-Antitrypsin deficiency (AATD) caused emphysema. The hypothesis is that emphysema in AATD patients shows similar tissue destruction profile was well as symptoms and thus will respond favorably to LVRC treatment, demonstrating improvement in lung function, exercise capacity, and quality of life relative to their baseline status.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Lung Volume Reduction Coil (PneumrX Inc.)Patients with Alpha-1-Antitrypsin deficiency treated with endoscopic lung volume reduction using Lung Volume Reduction Coils (PneumRx Inc.) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient > 18 years of age, diagnosed with AATD emphysema
- CT scan indicates bilateral heterogeneous or non-severe homogeneous emphysema, with sufficient lung parenchyma for coil deployment, in accordance with manufacturer recommendations (see section 5.2.4.1).
- Patient has post- bronchodilator FEV1 less than or equal to 45% predicted
- Total Lung Capacity > 100%
- Residual Volume (RV) >175% predicted
Key exclusion criteria (16 listed)
- Patient has a change in FEV1 > 20% post-bronchodilator.
- Patients DLCO < 20% predicted
- Patient has a history of recurrent clinically significant respiratory infection
- Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure >50mmHg and or evidenced by echocardiogram
- Patient has an inability to walk >140 meters (150 yards) in 6 minutes
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 |
|---|---|---|
| Lung Volume Reduction Coil (PneumrX Inc.)Endoscopic Lung Volume Reduction | Device | Treatment |
Primary outcome
symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) compared to the 6 months Follow-up Visit
Time frame: 6 months
Quality of Life
4 secondary outcomes
Percent change in FEV1 from Baseline (Pre-Treatment Visit)
Time frame: 6 and 12 months
Decrease in the Residual Volume and the RV/TLC ratio
Time frame: 6 and 12 months
Improvement in the 6 minute walk distance
Time frame: 6 and 12 months
Changes in mMRC Dyspnoe Scale
Time frame: 6 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
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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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Volume Reduction Coil (PneumrX Inc.) in people with Alpha-1-Antitrypsin Deficiency and Chronic Obstructive Lung Disease, run by University Hospital, Saarland at 2 sites in 2 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 10 inclusion and 16 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: withdrawn, as of the sponsor's last update on 2 May 2017. 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 Denmark, Germany. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) compared to the 6 months Follow-up Visit (time frame: 6 months). 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 2 May 2017.