The Spiration Valve System for the Treatment of Severe Emphysema

NCT01989182 | Completed

• 1 other identifier: TG1226SVS
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Empyhsema; Pulmonary Disease, Chronic Obstructive

Keywords

Endobronchial Valves; Intrabronchial Valves; Bronchial Valve; Chronic Obstructive Pulmonary Disease; COPD; Pulmonary Disease, Chronic Obstructive; Bronchoscopic Lung Volume Reduction; BLVR; TLVR; Emphysema; Pulmonary Emphysema; Pathologic Process; Lung Diseases; Respiratory Tract Disease; China; Spiration Valve System (SVS)

Outcome Measures

Primary Outcomes (1)

• Difference between treatment and control groups in the mean change in forced expiratory volume in one second (FEV1)

  Baseline and 3 Months

Secondary Outcomes (7)

• 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

Study Arms (2)

Treatment with Spiration Valve System

EXPERIMENTAL

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

Medical Management

ACTIVE COMPARATOR

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

Interventions

Spiration Valve System DEVICE

Treatment with Spiration Valve System

Medical Management OTHER

Medical Management; Treatment with Spiration Valve System

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• Patient must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m.
• Patient has abstained from cigarette smoking for 4 months and is willing to abstain throughout the study.
• Severe dyspnea defined as a mMRC ≥ 2.
• Patient's obstructive disease is severe as defined by:
• FEV1 ≤ 45% of predicted
• Patient's hyperinflation is defined by:
• TLC ≥ 100% of predicted
• RV ≥ 150% of predicted
• 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.
• 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.

You may not qualify if:

• 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
• Patient has a BMI \< 15 kg/m2 or \> 35 kg/m2
• Patient is unable to provide informed consent.
• Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures.
• Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
• 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.
• Patient has bronchitis with sputum production \> 60 ml per day.
• Patient has an active asthma component to their disease or requires more than 15 mg of prednisone daily (20 mg prednisolone).
• Patient has giant bulla (\> 1/3 volume in either lung).
• Patient has severe pulmonary hypertension based upon clinical evaluation.
• A patient with a malignant condition and/or a life threatening disease (other than COPD) that would likely affect the completion of the study
• 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.
• Patient has had prior lung volume reduction surgery or major lung procedures (lobectomy or greater).

Sponsors & Collaborators

• Olympus Corporation of the Americas: lead
• Olympus Corporation: collaborator
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (12)

Guangdong General Hospital

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Tangdu Hospital the Second Teaching Hospital of the Fourth Military Medical University

Xi'an, Shaanxi, China

Location

The First Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Location

Peking University First Hospital

Beijing, China

Location

The General Hospital of Chinese People's Liberation Army (301)

Beijing, China

Location

The Second Affiliated Hospital ZheJiang University School of Medicine

Hangzhou, China

Location

Shanghai Chest Hospital

Shanghai, China

Location

Shanghai Tenth People's Hospital

Shanghai, China

Location

Zhongshan Hospital Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Pulmonary Emphysema; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Nanshan Zhong, MD

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 20, 2013
• Study Start: November 8, 2013
• Primary Completion: May 18, 2016
• Study Completion: March 1, 2017
• Last Updated: February 14, 2018

Record last verified: 2018-02

Locations

CN (12)