The Spiration Valve System for the Treatment of Severe Emphysema (REACH)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive; Empyhsema
• Intervention / Treatment: Device: Spiration Valve System; Other: Medical Management

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Spiration Valve System; Subjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. Subjects assigned to this group will also receive medical management.	Device: Spiration Valve System; Other: Medical Management
Active Comparator: Medical Management; The control group for this study will receive medical management. This medical management group will be evaluated and followed in the same manner as the treatment group, but without having a bronchoscopic procedure.	Other: Medical Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference between treatment and control groups in the mean change in forced expiratory volume in one second (FEV1)	Baseline and 3 Months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Spiration, Inc.
• Collaborators: Tigermed Consulting Co., Ltd; Olympus Corporation
• Investigators: Principal Investigator: Nanshan Zhong, MD, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2013
• Primary Completion (Actual): May 18, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: November 14, 2013
• First Posted (Estimate): November 20, 2013

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: China; COPD; Lung Diseases; Chronic Obstructive Pulmonary Disease; Pulmonary Disease, Chronic Obstructive; Emphysema; Pulmonary Emphysema; Endobronchial Valves; Intrabronchial Valves; Bronchial Valve; Bronchoscopic Lung Volume Reduction; Respiratory Tract Disease; BLVR; TLVR; Pathologic Process; Spiration Valve System (SVS)
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema; Chronic Disease
• Other Study ID Numbers: TG1226SVS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No