EmphysemaNCT02470052
A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the OL-BF-001 for Severe Emphysema
A study testing OL-BF-001 in people with Emphysema, run by Olympus Corporation at 10 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Emphysema
- What is being tested?
- OL-BF-001
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 10 sitesJapan
- Study dates
- Aug 2015to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Subject has indicated Left ventricular ejection fraction(LVEF) ≤ 30% within 6 months prior to screening testing. *Subject,who had severe cardiovascular diseases in the past but can control them currently, doesn't meet this criteria.
- Subject is judged as ineligible due to a risk of hemoptysis by investigators.
- Subject has demonstrated unwillingness or inability to complete screening and/or baseline testing.
- Subject has α1-antitrypsin deficiency.
- Subject is classified as ASA Class greater than P4 or has comorbidities that could significantly increase the risk related with bronchoscopy procedure.
- Subject has latex allergy.
- Subject has metallic allergy.
- Subject participated in a study of an investigational drug or device within the 30 days prior to participation in this study, or is currently participating in another clinical study.
- Following women subjects are ineligible: Pregnant women, lactating women, potentially pregnant women, women who wish to become pregnant during the study period, women who cannot use birth control properly during the study period.
- Subject is considered as ineligible due to other factors by investigators.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Study site
Chiba
Study site
Fukuoka
Study site
Gifu
Study site
Kawasaki, Kanagawa
Study site
Matsusaka, Mie-ken
Study site
Mibu, Tochigi
Study site
Nagoya, Aichi-ken
Study site
Sapporo, Hokkaido
Study site
Toyoake, Aichi-ken
Study site
Ube, Yamaguchi
About this study
Official title: A Prospective, Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the OL-BF-001 for Severe Emphysema
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
- Being tested
- OL-BF-001
- 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
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OL-BF-001Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OL-BF-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6months after deployment of valves
Secondary outcomes (6)
Change in exercise capacity as measured by Six Minute Walk Test (6MWT)
Measured: before deployment of valves and 6months after deployment of valves
Change in dyspnea as measured by Baseline and Transition Dyspnea Indexes(BDI-TDI)
Measured: before deployment of valves and 6months after deployment of valves
Change in health status as measured by St. George's Respiratory Questionnaire(SGRQ)
Measured: before deployment of valves and 6months after deployment of valves
Change in dyspnea as measured by Medical Research Council, Modified (mMRC) Questionnaire
Measured: 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)
Measured: before deployment of valves and 6months after deployment of valves
Change in target lobe volume as measured by Quantitative CT (QCT)
Measured: before deployment of valves and 6months after deployment of valves
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionApr 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470052
- Sponsor's protocol ID
- OMSC-1401
- Status last verified
- Aug 2019
- First submitted
- 5 Jun 2015
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Single-arm, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the OL-BF-001 for Severe Emphysema
- ClinicalTrials.gov ID
- NCT02470052
- Acronym / sponsor ID
- OMSC-1401
- Conditions
- Emphysema
- Keywords
- Endobronchial Valves, Intrabronchial Valves, Bronchial Valve, Chronic Obstructive Pulmonary Disease, Pulmonary Disease, Chronic Obstructive, Bronchoscopic Lung Volume Reduction, Emphysema, Pulmonary Emphysema
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Olympus CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OL-BF-001 | Experimental | Device: OL-BF-001Subjects 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. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OL-BF-001Subjects 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 |
Primary outcome
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)
6 secondary outcomes
Change in exercise capacity as measured by Six Minute Walk Test (6MWT)
Time frame: before deployment of valves and 6months after deployment of valves
Change in dyspnea as measured by Baseline and Transition Dyspnea Indexes(BDI-TDI)
Time frame: before deployment of valves and 6months after deployment of valves
Change in health status as measured by St. George's Respiratory Questionnaire(SGRQ)
Time frame: before deployment of valves and 6months after deployment of valves
Change in dyspnea as measured by Medical Research Council, Modified (mMRC) Questionnaire
Time frame: 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)
Time frame: before deployment of valves and 6months after deployment of valves
Change in target lobe volume as measured by Quantitative CT (QCT)
Time frame: before deployment of valves and 6months after deployment of valves
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OL-BF-001 in people with Emphysema, run by Olympus Corporation at 10 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
responder rate after deployment of valves (time frame: 6months after deployment of valves). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019; AzTrials last refreshed its copy on 30 Oct 2026.