A Prospective, Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the OL-BF-001 for Severe Emphysema

Olympus Corporation0 sites38 target enrollmentAugust 2015

ConditionsEmphysema

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Emphysema
Sponsor: Olympus Corporation
Enrollment: 38
Primary Endpoint: responder rate after deployment of valves
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This is a multicenter,single-arm,open-label study designed to evaluate improvement of lung function and safety after treatment with OL-BF-001 for severe emphysema.

OL-BF-001 consists of a bronchial valve, deployment catheter, loader and airway sizing kit. A bronchial 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.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

August 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Olympus Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject is treated by maximum medical management（ pharmacological therapy and nonpharmacological therapy ) for 3 months and over before screening testing and the same treatment will be conducted during the study period.
•Subject must have severe dyspnea which is defined as a mMRC ≥
•Subject's obstructive disease is severe as defined by following post-bronchodilator spirometry values: FEV1/FVC \< 70% and 20% of predicted ≤ FEV1 \< 50% of predicted
•Subject's hyperinflation is defined by: RV/TLC ≥ 40%
•Subject has severe emphysema and high heterogeneity defined as: a target lobe with ≥ 50% emphysema involvement and clearly different with the ipsilateral lobe, which is judged by visual assessment of thoracic CT. Lung perfusion scan is added to the assessment in principle.
•The target lobe and ipsilateral lobe will be separated with an intact fissure. An intact fissure will be estimated visually to be ≥ 90% complete with no segmental vessels crossing from one lobe to the adjacent lobe.
•Subject must be able to demonstrate physical ability to participate in the study by performing a 6-minute walk distance of ≥ 140 m.
•Subject has abstained from cigarette smoking for 3 months and over before screening testing, and is able to continue to abstain throughout the study.
•Investigator has confirmed that medical management has been conducted enough and disease state has been stable and without a COPD exacerbation for 6 weeks and over before screening testing.
•Subject is able to participate in the study, complete the required follow-up visits, and maintain consistent nutrition and exercise habits during the study period.

Exclusion Criteria

•Subject has a severe gas exchange abnormality in either PaCO2 or PaO2 as defined by: PCO2 \> 50 mmHg, or PO2 \< 50 mmHg on room air
•Subject with DLCO \< 20% of predicted
•Subject has a BMI \< 15kg/m
•Subject has a risk of thromboembolism.(D-dimer value is used as a reference.)
•Subject had COPD exacerbation which required hospitalization or administration of systemic steroids twice or more in the past 1 year prior to screening testing.
•Subject has a history of pneumothorax twice or more in the past 1 year prior to screening testing.
•Subject has a large amount of sputum production on a daily basis.
•Subject has clinically apparent asthma.
•Subject has giant bulla (\> 1/3 volume in either lung. If subject has multiple bullae, the sum of them is judged whether or not \> 1/3 volume in either lung. )
•Patient has pulmonary hypertension based upon clinical evaluation.

Outcomes

Primary Outcomes

responder rate after deployment of valves

Time Frame: 6months after deployment of valves

definition of responder: St. George's Respiratory Questionnaire (SGRQ) improving and Pulmonary Function improving (either Forced Expiratory Volume in 1 second (FEV1) improving or Inspiratory Capacity (IC) improving)

Secondary Outcomes

Change in dyspnea as measured by Medical Research Council, Modified (mMRC) Questionnaire(before deployment of valves and 6months after deployment of valves)
Change in exercise capacity as measured by Six Minute Walk Test (6MWT)(before deployment of valves and 6months after deployment of valves)
Change in dyspnea as measured by Baseline and Transition Dyspnea Indexes(BDI-TDI)(before deployment of valves and 6months after deployment of valves)
Change in target lobe volume as measured by Quantitative CT (QCT)(before deployment of valves and 6months after deployment of valves)
Change in health status as measured by St. George's Respiratory Questionnaire(SGRQ)(before deployment of valves and 6months after deployment of valves)
Change in pulmonary function as measured by FEV1,Forced Vital Capacity(FVC),Vital Capacity(VC),Residual Volume(RV),IC,Total Lung Capacity(TLC),RV/TLC,Diffusing Capacity of the Lung for Carbon Monoxide(DLCO)(before deployment of valves and 6months after deployment of valves)