EmphysemaPhase 3STICREVOLENSNCT01822795
Lung Volume Reduction Coil Treatment in Emphysema.
A Phase 3 study testing Lung volume reduction coïl treatment and Regular medical treatment in people with Emphysema, run by CHU de Reims at 9 sites in France.
Trial summary
BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- Lung volume reduction coïl treatment and Regular medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesFrance
- Study dates
- Mar 2013to Dec 2019
- Phase
- Phase 3
- 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
- Bilateral emphysema on Chest CT Scanner
- Post bronchodilator FEV1 < 50 %
- Total Lung Capacity > 100 %
- Residual Volume > 220 %
- Dyspnea score between 2 and 4 based on the mMRC scale
- Stopped cigarette smoking for more than 8 weeks
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- Pulmonary rehabilitation within the previous twelve months
- Consent form signed
- Covered by Medical Insurance
Who cannot join
- Post bronchodilator FEV1 < 15%
- Post-bronchodilator change in FEV1 > 20%
- Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months
- COPD exacerbation requiring hospital stay within 3 months
- Pulmonary Hypertension (Pulmonary systolic pressure >50 mmHg on cardiac echo)
- Patient unable to perform a 6-min walking test in room air
Show all 17Show fewer
- Giant bulla of more than 1/3 of the lung field on Chest CT
- Strictly homogeneous emphysema on Chest CT
- Clinically significant bronchiectasis
- Past history of lobectomy, lung volume reduction surgery, lung transplantation
- Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…)
- Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
- Contra-indication to general anesthesia
- Oral anticoagulant treatment (antivitamin K)
- Allergy to nitinol
- Inclusion in an other study assessing respiratory treatments
- Patient protected by the law
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU d'Amiens
Amiens, 80054
CHU de Grenoble
Grenoble, 38043
AP-HM
Marseille, 13015
CHU de Montpellier
Montpellier, 34295
CHU de Nice
Nice, 06002
AP-HP - Hôpital Bichat
Paris, 75877
CHU de Rouen
Rouen, 76031
CHU de Saint-Etienne
Saint-Priest-en-Jarez, 42270
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.
- BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be feasible and associated with an acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity and lung function. The objective of this study is to analyze the cost effectiveness of LVRC treatment in severe emphysema.
- METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs conventional treatment) will include 100 patients who will be followed up for 1year. The primary outcome measure is the 6-month improvement of the 6-minute walk test: the percentage of patients showing an improvement of at least 54m will be compared between groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global cost of this therapeutic option and will compare the cost between patients treated by LVRC and by medical treatment alone.
- EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in severe emphysema. The cost-effectiveness study will assess the medical-economic impact of the LVRC therapeutic option.
- Conditions
- Emphysema
- Being tested
- Lung volume reduction coïl treatment, Regular medical treatment
- Keywords
- Chronic obstructive pulmonary disease, Endoscopic 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.
Lung volume reduction coïl treatmentProcedure or surgery
Regular medical treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Lung volume reduction coïl treatment | Experimental | Lung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention Receives: Procedure: Lung volume reduction coïl treatment; Other: Regular medical treatment |
| Regular Medical Treatment | Other | No intervention, just a follow up under usual medical treatment Receives: Other: Regular medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month improvement of the 6-minute walk test
6-month improvement of the 6-minute walk test : the percentage of patients showing an improvement of at least 54m will be compared between groups.
Measured: 6 months
Secondary outcomes (5)
Cost-effectiveness
Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores.
Measured: 6 and 12 months
Dyspnea
Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale
Measured: 6 and 12 months
Pulmonary function assessment
Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC.
Measured: 6 and 12 months
Quality of life
Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions)
Measured: 6 and 12 months
Morbidity-mortality
Comparison of mortality and severe adverse events using a composite score (death, haemoptysis > 150 cc, pneumonia requiring hospitalization, pneumothorax requiring chest tube drainage > 7 days, mechanical ventilation > 24 hours, lung transplantation).
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 posted2 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2015 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Collaborators
- PneumRx, Inc.
- Responsible party
- Sponsor
- Investigators
- Gaëtan DESLEE, PhD, MD, Principal investigator, CHU de Reims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822795
- Sponsor's protocol ID
- PD12133
- Acronym
- STICREVOLENS
- Status last verified
- Apr 2014
- First submitted
- 28 Mar 2013
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deslee G, Barbe C, Bourdin A, Durand-Zaleski I, Dutau H, Jolly D, Jounieaux V, Kessler R, Mal H, Pison C, Thiberville L, Vergnon JM, Marquette CH. [Cost-effectiveness of lung volume reduction coil treatment in emphysema. STIC REVOLENS]. Rev Mal Respir. 2012 Nov;29(9):1157-64. doi: 10.1016/j.rmr.2012.09.010. Epub 2012 Oct 12. French.
PubMed 23200592Perotin JM, Leroy S, Marquette CH, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Barbe C, Deslee G; REVOLENS Study Group. Endobronchial coil treatment in severe emphysema patients with alpha-1 antitrypsin deficiency. Int J Chron Obstruct Pulmon Dis. 2018 Nov 5;13:3645-3649. doi: 10.2147/COPD.S176366. eCollection 2018.
PubMed 30464447Bulsei J, Leroy S, Perotin JM, Mal H, Marquette CH, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Salaun M, Marceau A, Dukic S, Barbe C, Bonnaire M, Deslee G, Durand-Zaleski I; REVOLENS study group. Cost-effectiveness of lung volume reduction coil treatment in patients with severe emphysema: results from the 2-year follow-up crossover REVOLENS study (REVOLENS-2 study). Respir Res. 2018 May 9;19(1):84. doi: 10.1186/s12931-018-0796-x.
PubMed 29743071Deslee G, Leroy S, Perotin JM, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Salaun M, Marceau A, Dury S, Benzaquen J, Bonnaire M, Dukic S, Barbe C, Marquette CH; , on behalf of the REVOLENS Study Group13; REVOLENS Study Group. Two-year follow-up after endobronchial coil treatment in emphysema: results from the REVOLENS study. Eur Respir J. 2017 Dec 21;50(6):1701740. doi: 10.1183/13993003.01740-2017. Print 2017 Dec. No abstract available.
PubMed 29269583Deslee G, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Thiberville L, Leroy S, Marceau A, Laroumagne S, Mallet JP, Dukic S, Barbe C, Bulsei J, Jolly D, Durand-Zaleski I, Marquette CH; REVOLENS Study Group. Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):175-84. doi: 10.1001/jama.2015.17821.
PubMed 26757466
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.
- ClinicalTrials.gov ID
- NCT01822795
- Acronym / sponsor ID
- STICREVOLENS / PD12133
- Conditions
- Emphysema
- Keywords
- Chronic obstructive pulmonary disease, Endoscopic lung volume reduction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Collaborators
- PneumRx, Inc.
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Apr 2013 (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.
- BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be feasible and associated with an acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity and lung function. The objective of this study is to analyze the cost effectiveness of LVRC treatment in severe emphysema.
- METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs conventional treatment) will include 100 patients who will be followed up for 1year. The primary outcome measure is the 6-month improvement of the 6-minute walk test: the percentage of patients showing an improvement of at least 54m will be compared between groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global cost of this therapeutic option and will compare the cost between patients treated by LVRC and by medical treatment alone.
- EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in severe emphysema. The cost-effectiveness study will assess the medical-economic impact of the LVRC therapeutic option.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung volume reduction coïl treatment | Experimental | Procedure: Lung volume reduction coïl treatment, Other: Regular medical treatmentLung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention |
| Regular Medical Treatment | Other | Other: Regular medical treatmentNo intervention, just a follow up under usual medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Bilateral emphysema on Chest CT Scanner
- Post bronchodilator FEV1 < 50 %
- Total Lung Capacity > 100 %
- Residual Volume > 220 %
- Dyspnea score between 2 and 4 based on the mMRC scale
Key exclusion criteria (17 listed)
- Post bronchodilator FEV1 < 15%
- Post-bronchodilator change in FEV1 > 20%
- Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months
- COPD exacerbation requiring hospital stay within 3 months
- Pulmonary Hypertension (Pulmonary systolic pressure >50 mmHg on cardiac echo)
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 coïl treatment | Procedure or surgery | Lung volume reduction coïl treatment |
| Regular medical treatment | Other | Lung volume reduction coïl treatment, Regular Medical Treatment |
Primary outcome
6-month improvement of the 6-minute walk test
Time frame: 6 months
6-month improvement of the 6-minute walk test : the percentage of patients showing an improvement of at least 54m will be compared between groups.
5 secondary outcomes
Cost-effectiveness
Time frame: 6 and 12 months
Dyspnea
Time frame: 6 and 12 months
Pulmonary function assessment
Time frame: 6 and 12 months
Quality of life
Time frame: 6 and 12 months
Morbidity-mortality
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
- Background: PubMed 23200592Deslee G, Barbe C, Bourdin A, Durand-Zaleski I, Dutau H, Jolly D, Jounieaux V, Kessler R, Mal H, Pison C, Thiberville L, Vergnon JM, Marquette CH. [Cost-effectiveness of lung volume reduction coil treatment in emphysema. STIC REVOLENS]. Rev Mal Respir. 2012 Nov;29(9):1157-64. doi: 10.1016/j.rmr.2012.09.010. Epub 2012 Oct 12. French.
- Derived from this study: PubMed 30464447Perotin JM, Leroy S, Marquette CH, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Barbe C, Deslee G; REVOLENS Study Group. Endobronchial coil treatment in severe emphysema patients with alpha-1 antitrypsin deficiency. Int J Chron Obstruct Pulmon Dis. 2018 Nov 5;13:3645-3649. doi: 10.2147/COPD.S176366. eCollection 2018.
- Derived from this study: PubMed 29743071Bulsei J, Leroy S, Perotin JM, Mal H, Marquette CH, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Salaun M, Marceau A, Dukic S, Barbe C, Bonnaire M, Deslee G, Durand-Zaleski I; REVOLENS study group. Cost-effectiveness of lung volume reduction coil treatment in patients with severe emphysema: results from the 2-year follow-up crossover REVOLENS study (REVOLENS-2 study). Respir Res. 2018 May 9;19(1):84. doi: 10.1186/s12931-018-0796-x.
- Derived from this study: PubMed 29269583Deslee G, Leroy S, Perotin JM, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Salaun M, Marceau A, Dury S, Benzaquen J, Bonnaire M, Dukic S, Barbe C, Marquette CH; , on behalf of the REVOLENS Study Group13; REVOLENS Study Group. Two-year follow-up after endobronchial coil treatment in emphysema: results from the REVOLENS study. Eur Respir J. 2017 Dec 21;50(6):1701740. doi: 10.1183/13993003.01740-2017. Print 2017 Dec. No abstract available.
- Derived from this study: PubMed 26757466Deslee G, Mal H, Dutau H, Bourdin A, Vergnon JM, Pison C, Kessler R, Jounieaux V, Thiberville L, Leroy S, Marceau A, Laroumagne S, Mallet JP, Dukic S, Barbe C, Bulsei J, Jolly D, Durand-Zaleski I, Marquette CH; REVOLENS Study Group. Lung Volume Reduction Coil Treatment vs Usual Care in Patients With Severe Emphysema: The REVOLENS Randomized Clinical Trial. JAMA. 2016 Jan 12;315(2):175-84. doi: 10.1001/jama.2015.17821.
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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.
Gaëtan DESLEE, PhD, MD principal investigator
CHU de Reims
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lung volume reduction coïl treatment and Regular medical treatment in people with Emphysema, run by CHU de Reims at 9 sites in France.
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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 30 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
6-month improvement of the 6-minute walk test (time frame: 6 months). 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 NCT01822795, which also lists 5 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 30 Apr 2014.