The Spiration Valve System for the Treatment of Severe Emphysema

Pulmonary Disease, Chronic Obstructive Clinical Trial

— REACH  

Official title:

The Spiration Valve System for the Treatment of Severe Emphysema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989182
• Other study ID #: TG1226SVS
• Status: Completed
• Phase: N/A
• First received: November 6, 2013
• Last updated: February 12, 2018
• Start date: November 8, 2013
• Est. completion date: March 2017

Study information

• Verified date: February 2018
• Source: Spiration, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, prospective, randomized, controlled study being conducted in China to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.

The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: March 2017
• Est. primary completion date: May 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patient has severe emphysema and high heterogeneity by visual assessment defined as:

• a target lobe with = 40% emphysema involvement and

• = 15% difference with the ipsilateral lobe.

2. The target lobe and ipsilateral lobe will be separated with an intact fissure. An intact fissure will be estimated visually to be =90% complete after viewing the HRCT in 3 dimensions.

3. Patient has received optimal medical management and it has been stable for 6 weeks prior to baseline testing. If pulmonary rehabilitation has been recent, it will be completed at least 3 months prior to baseline testing.

4. Patient must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of = 140 m.

5. Patient has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study.

6. Severe dyspnea defined as a mMRC = 2.

7. Patient's obstructive disease is severe as defined by:

• FEV1 = 45% of predicted

8. Patient's hyperinflation is defined by:

• TLC = 100% of predicted

• RV = 150% of predicted

9. Patient is willing to participate in a study, complete the required follow-up visits, and maintain consistent nutrition and exercise habits during the study period.

10. Investigator has confirmed that medical management is within standard of care and patient has been stable and without a COPD exacerbation for 6 weeks or more.

Exclusion Criteria:

1. Patient has severe gas exchange abnormalities as defined by:

• PCO2 > 50 mm Hg (6.6 kPa), or

• PaO2 < 45 mm Hg (6.0 kPa) on room air

2. Patient has a BMI < 15 kg/m2 or > 35 kg/m2

3. Patient is unable to provide informed consent.

4. Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures.

5. Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.

6. Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory infections in the past year or has had a COPD exacerbation in the 3 months prior to baseline testing.

7. Patient has bronchitis with sputum production > 60 ml per day.

8. Patient has an active asthma component to their disease or requires more than 15 mg of prednisone daily (20 mg prednisolone).

9. Patient has giant bulla (> 1/3 volume in either lung).

10. Patient has severe pulmonary hypertension based upon clinical evaluation.

11. A patient with a malignant condition and/or a life threatening disease (other than COPD) that would likely affect the completion of the study

12. Patient has any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints. This would include neurological or musculoskeletal conditions that may interfere with testing.

13. Patient has had prior lung volume reduction surgery or major lung procedures (lobectomy or greater).

14. Patient has a lung nodule anticipated to require evaluation or intervention during the 3 month study period.

15. Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.

16. Patient has a diffuse emphysema pattern, diffuse pulmonary fibrosis, or pulmonary tuberculosis (active, extensive, or with adhesive pleural incrassation).

17. Patient is classified as ASA Class greater than P4 including presence of co-morbidity that could significantly increase the risk of a bronchoscopy procedure.

18. Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study.

19. Female patient of childbearing potential has a positive result from a pregnancy test required during the 7 days prior to the procedure.

Related Conditions & MeSH terms

• Chronic Disease
• Emphysema
• Empyhsema
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

Device:
• Spiration Valve System

Other:
• Medical Management

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing
China	The General Hospital of Chinese People's Liberation Army (301)	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	Guangdong General Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The Second Affiliated Hospital ZheJiang University School of Medicine	Hangzhou
China	Shanghai Chest Hospital	Shanghai
China	Shanghai Tenth People's Hospital	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
China	The First Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	Tangdu Hospital the Second Teaching Hospital of the Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (3)

Lead Sponsor	Collaborator
Spiration, Inc.	Olympus Corporation, Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between treatment and control groups in the mean change in forced expiratory volume in one second (FEV1)		Baseline and 3 Months
Secondary	Incidence of device-related serious adverse events		Baseline and 3 Months
Secondary	Difference between responder rates in the treatment and control groups, with a responder defined as = 15% improvement in FEV1		Baseline and 3 Months
Secondary	Target lobe volume reduction as measured by QCT		Baseline and 3 Months
Secondary	Health Status as measured by St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT)		Baseline and 3 Months
Secondary	Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC)		Baseline and 3 Months
Secondary	Exercise capacity as measured by Six Minute Walk Test (6MWT)		Baseline and 3 Months
Secondary	Hyperinflation as measured by Residual Volume (RV)		Baseline and 3 Months