Lung Volume Reduction Coil Treatment in Emphysema.

Emphysema Clinical Trial

— STICREVOLENS  

Official title:

Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01822795
• Other study ID #: PD12133
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 28, 2013
• Last updated: April 29, 2014
• Start date: March 2013
• Est. completion date: December 2019

Study information

• Verified date: April 2014
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Inclusion in an other study assessing respiratory treatments

• Patient protected by the law

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Procedure:
• Lung volume reduction coïl treatment

Other:
• Regular medical treatment

Locations

Country	Name	City	State
France	CHU d'Amiens	AMIENS Cedex 1
France	CHU de Grenoble	GRENOBLE Cedex 9
France	AP-HM	Marseille
France	CHU de Montpellier	MONTPELLIER Cedex 5
France	CHU de Nice	Nice
France	AP-HP - Hôpital Bichat	PARIS Cedex 18
France	CHU de Rouen	ROUEN Cedex
France	CHU de Saint-Etienne	Saint-priest-en-jarez
France	Hôpitaux Universitaires de Strasbourg	STRASBOURG Cedex

Sponsors (2)

Lead Sponsor	Collaborator
CHU de Reims	PneumRx, Inc.

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exercise testing	Comparison of the 6-min walking test between groups (using the > 25 meters change from baseline as cut-off for clinically significant change).	6 and 12 months months	No
Other	Exercise testing	Comparison of the 6-min walking distance at 12 months using 54 meters as cut-off for clinically significant change.	12 months	No
Primary	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	No
Secondary	Cost-effectiveness	Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores.	6 and 12 months	No
Secondary	Dyspnea	Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale	6 and 12 months	No
Secondary	Pulmonary function assessment	Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC.	6 and 12 months	No
Secondary	Quality of life	Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions)	6 and 12 months	No
Secondary	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).	6 and 12 months	Yes

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