A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the OL-BF-001 for Severe Emphysema

NCT02470052 | Terminated

• 1 other identifier: OMSC-1401
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 10

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.

Conditions

Emphysema

Keywords

Endobronchial Valves; Intrabronchial Valves; Bronchial Valve; Chronic Obstructive Pulmonary Disease; Pulmonary Disease, Chronic Obstructive; Bronchoscopic Lung Volume Reduction; Emphysema; Pulmonary Emphysema; Lung Diseases; Respiratory Tract Disease

Outcome Measures

Primary Outcomes (1)

• responder rate 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)

  6months after deployment of valves

Secondary Outcomes (6)

• 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 health status as measured by St. George's Respiratory Questionnaire(SGRQ)

  before deployment of valves and 6months after deployment of valves

• Change in dyspnea as measured by Medical Research Council, Modified (mMRC) Questionnaire

  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

Other Outcomes (2)

• Incidence of Severe and Serious Adverse Events(SAEs) whose relationship with the investigational device or the procedure cannot be ruled out

  before deployment of valves and 6months after deployment of valves

• Incidence of Adverse Events(AEs) whose relationship with the investigational device or the procedure cannot be ruled out

  before deployment of valves and 6months after deployment of valves

Study Arms (1)

OL-BF-001

EXPERIMENTAL

Subjects assigned to this study will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. The subjects will also receive medical management.

Device: OL-BF-001

Interventions

OL-BF-001 DEVICE

Subjects assigned to this study will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. The subjects will also receive medical management.

OL-BF-001

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 2.
• 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.
• Subject provides informed consent and is willing and able to return for all study examinations.

You may not qualify if:

• 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/m2.
• 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.
• Subject uses oral steroids 10 mg/day and over in prednisolone conversion.
• Subject has comorbidities that will limit participation in the study, or follow-up during the study period.
• Subject has a history of thoracic surgeries.
• Subject has thoracic comorbidities (lung nodules, infections(e.g. Pulmonary tuberculosis), Interstitial pneumonia, etc.) , which are anticipated to require evaluation or intervention during the 12 months study period.
• Subject is strongly suspected of pleural adhesions.

Sponsors & Collaborators

• Olympus Corporation: lead

Study Sites (10)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Toyoake, Aichi-ken, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Kawasaki, Kanagawa, Japan

Location

Unknown Facility

Matsusaka, Mie-ken, Japan

Location

Unknown Facility

Mibu, Tochigi, Japan

Location

Unknown Facility

Ube, Yamaguchi, Japan

Location

Unknown Facility

Chiba, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Gifu, Japan

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 12, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

JP (10)