Lung Volume Reduction Coil Treatment in Emphysema.

NCT01822795 | Unknown Phase 3 DMC

• 1 other identifier: PD12133
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

Brief 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 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

Keywords

Chronic obstructive pulmonary disease; Endoscopic lung volume reduction

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• Cost-effectiveness

  6 and 12 months

• Dyspnea

  6 and 12 months

• Pulmonary function assessment

  6 and 12 months

• Quality of life

  6 and 12 months

• Morbidity-mortality

  6 and 12 months

Other Outcomes (2)

• Exercise testing

  6 and 12 months months

• Exercise testing

  12 months

Study Arms (2)

Lung volume reduction coïl treatment

EXPERIMENTAL

Lung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention

Procedure: Lung volume reduction coïl treatment; Other: Regular medical treatment

Regular Medical Treatment

OTHER

No intervention, just a follow up under usual medical treatment

Other: Regular medical treatment

Interventions

Lung volume reduction coïl treatment PROCEDURE

Lung volume reduction coïl treatment

Regular medical treatment OTHER

Lung volume reduction coïl treatment; Regular Medical Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Pulmonary rehabilitation within the previous twelve months
• Consent form signed
• Covered by Medical Insurance

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• CHU de Reims: lead
• PneumRx, Inc.: collaborator

Study Sites (9)

CHU d'Amiens

Amiens, 80054, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

AP-HM

Marseille, 13015, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

CHU de Nice

Nice, 06002, France

Location

AP-HP - Hôpital Bichat

Paris, 75877, France

Location

CHU de Rouen

Rouen, 76031, France

Location

CHU de Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (5)

• 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.

  PMID: 23200592 BACKGROUND

• Perotin 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.

  PMID: 30464447 DERIVED

• Bulsei 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.

  PMID: 29743071 DERIVED

• Deslee 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.

  PMID: 29269583 DERIVED

• Deslee 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.

  PMID: 26757466 DERIVED

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Officials

• Gaëtan DESLEE, PhD, MD

  CHU de Reims

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 2, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2019
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

FR (9)