Chronic Obstructive Pulmonary DiseaseIBVNCT00880724
European Multi-center Post Market Study of the IBV Valve System
A study testing IBV Valve in people with Chronic Obstructive Pulmonary Disease, run by Olympus Corporation of the Americas at 7 sites in 6 countries.
Trial summary
The objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the IBV Valve System (treatment group) to a control group receiving a sham bronchoscopy procedure without valve placement. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- IBV Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Mar 2007to Jun 2010
- 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 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 40 and 74 years of age
- Predominantly upper lobe emphysema and severe dyspnea
- Satisfies the criteria of the ATS/ERS Guidelines for Management of Stable COPD
- Physical ability to participate in the study by performing a 6-minute walk distance of > 140m
- No cigarette smoking for 4 months and willing to abstain throughout the study
- Severe airflow obstruction defined by FEV1 45% of predicted
- Severe hyperinflation defined by: TLC > 100% of predicted and RV > 150% of predicted
Who cannot join
- Between 70 and 74 years of age and an FEV1 or DLCO < 20% of predicted
- Severe gas exchange abnormalities
- Major medical disease that will limit evaluation, participation or follow-up
- Active asthma component to their disease
- Giant bulla (> 1/3 volume of lung)
- Severe pulmonary hypertension
- Requirement for > 6L02 to keep saturation > 90% with exercise
- Evidence of systemic disease or neoplasia expected to compromise survival during the 6-month study period
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
Spain2 sites
Bellvitge Hospital
Barcelona
Clinica Universitaria de Navarra
Pamplona
United Kingdom1 site
Royal Preston Hospital/Lancashire Teaching Hospitals
Preston
About this study
Official title: European Post Market Study: A Prospective, Randomized, Controlled, Multicenter Study to Evaluate the Performance of the IBV Valve System for the Treatment of Severe Emphysema
The objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the IBV Valve System (treatment group) to a control group receiving a sham bronchoscopy procedure without valve placement.
Read the detailed description
The IBV Valve System (Spiration Inc. Redmond, WA) has CE Mark approval for the treatment of diseased and damaged lung. The devices are one-way valves that can be placed in the airways via flexible bronchoscopy limiting airflow distally. For the treatment of emphysema, valves are placed in airways communicating to the most diseased areas of lung tissue to re-direct airflow to less diseased areas. A multicenter, blinded and randomized study of these valves is being conducted in 7 centers in 6 European countries. The study is evaluating the effectiveness of this therapy for the treatment of upper lobe predominant emphysema in patients with severe to very severe emphysema (GOLD classification 3 to 4) that despite best medical management continue having poor quality of life, severe symptoms and physical limitations. The primary endpoints are to measure and compare responses using the St. George's Respiratory Questionnaire and lung volume changes as measured by CT-scans. Consented patients that meet the strict inclusion criteria have a bronchoscopic procedure and are randomized into treatment or control (no valves) groups. After the procedure, all patients stay blinded to their group assignment and have follow-up evaluations at 1 and 3 months. After the 3-month evaluation, each patient is un-blinded. The treatment group is then scheduled for an additional follow-up at 6 months and the control group is offered valve treatment (rollover) and evaluated approximately 3 months later.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- IBV Valve
- Keywords
- COPD, Emphysema, Bronchoscopic Treatment, Interventional Bronchoscopy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBV ValveDevice
Also called BLVR, Endoscopic Volume Reduction, Endobronchial Valve
Placement of IBV Valve in the airways of treatment subjects. Bronchoscopic procedure in control group.
| Study group | Role | What they receive |
|---|---|---|
| Medical management | No intervention | Not described Receives: Device: IBV Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the response rates of the treatment and control groups.
Measured: 3-months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2009 (estimated)
- Study startMar 2007
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00880724
- Sponsor's protocol ID
- CPR-01576 AD
- Acronym
- IBV
- Status last verified
- Jun 2009
- First submitted
- 10 Apr 2009
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ninane V, Geltner C, Bezzi M, Foccoli P, Gottlieb J, Welte T, Seijo L, Zulueta JJ, Munavvar M, Rosell A, Lopez M, Jones PW, Coxson HO, Springmeyer SC, Gonzalez X. Multicentre European study for the treatment of advanced emphysema with bronchial valves. Eur Respir J. 2012 Jun;39(6):1319-25. doi: 10.1183/09031936.00019711.
PubMed 22654006
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Post Market Study: A Prospective, Randomized, Controlled, Multicenter Study to Evaluate the Performance of the IBV Valve System for the Treatment of Severe Emphysema
- ClinicalTrials.gov ID
- NCT00880724
- Acronym / sponsor ID
- IBV / CPR-01576 AD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Emphysema, Bronchoscopic Treatment, Interventional Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 14 Apr 2009 (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.
The objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the IBV Valve System (treatment group) to a control group receiving a sham bronchoscopy procedure without valve placement.
Detailed description
The IBV Valve System (Spiration Inc. Redmond, WA) has CE Mark approval for the treatment of diseased and damaged lung. The devices are one-way valves that can be placed in the airways via flexible bronchoscopy limiting airflow distally. For the treatment of emphysema, valves are placed in airways communicating to the most diseased areas of lung tissue to re-direct airflow to less diseased areas. A multicenter, blinded and randomized study of these valves is being conducted in 7 centers in 6 European countries. The study is evaluating the effectiveness of this therapy for the treatment of upper lobe predominant emphysema in patients with severe to very severe emphysema (GOLD classification 3 to 4) that despite best medical management continue having poor quality of life, severe symptoms and physical limitations. The primary endpoints are to measure and compare responses using the St. George's Respiratory Questionnaire and lung volume changes as measured by CT-scans. Consented patients that meet the strict inclusion criteria have a bronchoscopic procedure and are randomized into treatment or control (no valves) groups. After the procedure, all patients stay blinded to their group assignment and have follow-up evaluations at 1 and 3 months. After the 3-month evaluation, each patient is un-blinded. The treatment group is then scheduled for an additional follow-up at 6 months and the control group is offered valve treatment (rollover) and evaluated approximately 3 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical management | No intervention | Device: IBV Valve |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between 40 and 74 years of age
- Predominantly upper lobe emphysema and severe dyspnea
- Satisfies the criteria of the ATS/ERS Guidelines for Management of Stable COPD
- Physical ability to participate in the study by performing a 6-minute walk distance of > 140m
- No cigarette smoking for 4 months and willing to abstain throughout the study
Key exclusion criteria (8 listed)
- Between 70 and 74 years of age and an FEV1 or DLCO < 20% of predicted
- Severe gas exchange abnormalities
- Major medical disease that will limit evaluation, participation or follow-up
- Active asthma component to their disease
- Giant bulla (> 1/3 volume of lung)
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 |
|---|---|---|
| IBV ValveAlso: BLVR, Endoscopic Volume Reduction, Endobronchial ValvePlacement of IBV Valve in the airways of treatment subjects. Bronchoscopic procedure in control group. | Device | Medical management |
Primary outcome
The difference between the response rates of the treatment and control groups.
Time frame: 3-months post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Derived from this study: PubMed 22654006Ninane V, Geltner C, Bezzi M, Foccoli P, Gottlieb J, Welte T, Seijo L, Zulueta JJ, Munavvar M, Rosell A, Lopez M, Jones PW, Coxson HO, Springmeyer SC, Gonzalez X. Multicentre European study for the treatment of advanced emphysema with bronchial valves. Eur Respir J. 2012 Jun;39(6):1319-25. doi: 10.1183/09031936.00019711.
- Sponsor websiteLink provided by the sponsor.
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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.
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IBV Valve in people with Chronic Obstructive Pulmonary Disease, run by Olympus Corporation of the Americas at 7 sites in 6 countries.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain, Austria, Belgium, Germany, Italy and 1 more country. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The difference between the response rates of the treatment and control groups. (time frame: 3-months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00880724, which also lists 1 linked publication.
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 9 May 2017.