Clinical trial NCT01989182: The Spiration Valve System for the Treatment of Severe Emphysema
Official title: The Spiration Valve System for the Treatment of Severe Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: Olympus Corporation of the Americas
Sponsor class: INDUSTRY
Collaborators: name: Olympus Corporation
name: Tigermed Consulting Co., Ltd
First posted: 2013-11-20
Enrollment: 107
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference between treatment and control groups in the mean change in forced expiratory volume in one second (FEV1)
timeFrame: Baseline and 3 Months
Secondary outcomes:
measure: Incidence of device-related serious adverse events
timeFrame: Baseline and 3 Months
measure: Difference between responder rates in the treatment and control groups, with a responder defined as ≥ 15% improvement in FEV1
timeFrame: Baseline and 3 Months
measure: Target lobe volume reduction as measured by QCT
timeFrame: Baseline and 3 Months
measure: Health Status as measured by St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT)
timeFrame: Baseline and 3 Months
measure: Dyspnea as measured by Modified Medical Research Council Questionnaire (mMRC)
timeFrame: Baseline and 3 Months
measure: Exercise capacity as measured by Six Minute Walk Test (6MWT)
timeFrame: Baseline and 3 Months
measure: Hyperinflation as measured by Residual Volume (RV)
timeFrame: Baseline and 3 Months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Xi'an
country: China
facility: Tangdu Hospital the Second Teaching Hospital of the Fourth Military Medical University
state: Shaanxi
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: The General Hospital of Chinese People's Liberation Army (301)
city: Hangzhou
country: China
facility: The Second Affiliated Hospital ZheJiang University School of Medicine
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Nanshan Zhong, MD
role: PRINCIPAL_INVESTIGATOR
References: