Heterogeneous EmphysemaPhase 3NCT00825578
Use of Endobronchial Valves in Non-Upper Lobe Heterogeneous Emphysema
A Phase 3 study testing Intra-bronchial valve (Spiration IBV) in people with Heterogeneous Emphysema, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other than the upper lobes, as determined by high resolution computed tomography (HRCT), could have a positive response to valve treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heterogeneous Emphysema
- What is being tested?
- Intra-bronchial valve (Spiration IBV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Ex-smoker with smoking cessation confirmed by exhaled carbon monoxide (CO) levels
- Moderate to severe airflow obstruction FEV1 <50% Predicted
- Severe dyspnoea - mMRC ≥2
- Hyperinflation - total lung capacity (TLC) ≥100% predicted, RV ≥150% predicted
- SWT ≥75m
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- Optimum COPD treatment for at least 6 weeks
- No COPD exacerbation for at least 6 weeks
- Less than 4 admissions for exacerbation in the preceding 12 months
Who cannot join
- Patient unable to provide informed consent
- Patient without clear targets for airflow re-distribution
- Total lung CO uptake (TLCO) <15% predicted and FEV1 <15% predicted
- pO2 on air <6.0kPa
- pCO2 on air >8.0kPa
- Neurological, rheumatological or other cause of exercise limitation
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- Other major medical illness, e.g. lung cancer that will limit participation
- Production of purulent sputum more often than not (more than 50% of days)
- Clinically significant bronchiectasis
- Large bulla - more than 1/3 of hemithorax volume (i.e. where bullectomy would be more suitable) on CT scan
- Arrhythmia or cardiovascular disease that poses a risk during procedure or exercise
- Prednisolone dose greater than 15mg a day
- Significant pulmonary hypertension - RVSP ≥45mmHg
- Left ventricular failure - left ventricular ejection fraction <45% or left ventricular fraction shortening <23%
- Prior LVRS or lobectomy
- Lung nodule requiring surgery
- Subject completed or is participating in a standard pulmonary rehabilitation program within 3 months of enrolment
- Female of childbearing age with positive pregnancy test
- Subject participated in a research study of investigational drug or device in prior 30 days
- Subject taking clopidogrel, warfarin, or other anticoagulants and unable to abstain for 5 days pre-procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Bronchoscopic Lung Volume Reduction to Evaluate Relative Efficacy in Patients With Non-Upper Lobe Emphysema
Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other than the upper lobes, as determined by high resolution computed tomography (HRCT), could have a positive response to valve treatment.
- Conditions
- Heterogeneous Emphysema
- Being tested
- Intra-bronchial valve (Spiration IBV)
- Keywords
- intrabronchial valve, heterogeneous emphysema, non-upper lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-bronchial valve (Spiration IBV)Device
Also called Spiration IBV
Device: Intra-bronchial valve (Spiration IBV) The IBV is comprised of a Nitnol frame and a polymer membrane, which is held against the airway mucosa by six elastic struts and will expand and contract with airway movement during breathing. The valve is designed to conform to the size and shape of the airways. The frame has 5 flexible anchors that gently secure to the mucosal wall at a controlled depth. Valves are available in 5, 6 and 7mm diameters appropriate for different airways. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the airways through the mouth) to deploy the umbrella-shaped valves into the airways. Only flexible bronchoscopy equipment is required. The valves are designed to be removed if indicated.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Upper-lobe predominant emphysema Receives: Device: Intra-bronchial valve (Spiration IBV) |
| 2 | Active comparator | Non-upper lobe predominant emphysema Receives: Device: Intra-bronchial valve (Spiration IBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan
Measured: 6 months
Secondary outcomes (9)
To estimate the difference between study arms in volume changes of the non-treated lobes by CT scan
Measured: 6 months
To estimate the difference between study arms in residual volume
Measured: 6 months
To estimate the difference between study arms in FEV1
Measured: 6 months
To estimate the difference between study arms in gas transfer
Measured: 6 months
To estimate the difference between study arms in modified MRC dyspnoea score
Measured: 6 months
To estimate the difference between study arms on a 6 minute walk test
Measured: 6 months
To estimate the difference between study arms in disease specific health status
Measured: 6 months
To estimate the difference between study arms in dynamic hyperinflation during cycle ergometry
Measured: 6 months
To estimate the difference between study arms in changes in respiratory and quadriceps muscle strength
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heterogeneous 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pallav Shah, MBBS, MD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825578
- Sponsor's protocol ID
- 08/H0708/84
- Status last verified
- Feb 2012
- First submitted
- 19 Jan 2009
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Bronchoscopic Lung Volume Reduction to Evaluate Relative Efficacy in Patients With Non-Upper Lobe Emphysema
- ClinicalTrials.gov ID
- NCT00825578
- Acronym / sponsor ID
- 08/H0708/84
- Conditions
- Heterogeneous Emphysema
- Keywords
- intrabronchial valve, heterogeneous emphysema, non-upper lobe
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Jan 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.
Hypothesis: Patients with advanced emphysema with predominance of the disease in areas other than the upper lobes, as determined by high resolution computed tomography (HRCT), could have a positive response to valve treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Intra-bronchial valve (Spiration IBV)Upper-lobe predominant emphysema |
| 2 | Active comparator | Device: Intra-bronchial valve (Spiration IBV)Non-upper lobe predominant emphysema |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-80 years
- Ex-smoker with smoking cessation confirmed by exhaled carbon monoxide (CO) levels
- Moderate to severe airflow obstruction FEV1 <50% Predicted
- Severe dyspnoea - mMRC ≥2
- Hyperinflation - total lung capacity (TLC) ≥100% predicted, RV ≥150% predicted
Key exclusion criteria (20 listed)
- Patient unable to provide informed consent
- Patient without clear targets for airflow re-distribution
- Total lung CO uptake (TLCO) <15% predicted and FEV1 <15% predicted
- pO2 on air <6.0kPa
- pCO2 on air >8.0kPa
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 |
|---|---|---|
| Intra-bronchial valve (Spiration IBV)Also: Spiration IBVDevice: Intra-bronchial valve (Spiration IBV) The IBV is comprised of a Nitnol frame and a polymer membrane, which is held against the airway mucosa by six elastic struts and will expand and contract with airway movement during breathing. The valve is designed to conform to the size and shape of the airways. The frame has 5 flexible anchors that gently secure to the mucosal wall at a controlled depth. Valves are available in 5, 6 and 7mm diameters appropriate for different airways. During a minimally invasive procedure, a catheter is passed through a bronchoscope (a flexible tube passed into the airways through the mouth) to deploy the umbrella-shaped valves into the airways. Only flexible bronchoscopy equipment is required. The valves are designed to be removed if indicated. | Device | 1, 2 |
Primary outcome
To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan
Time frame: 6 months
9 secondary outcomes
To estimate the difference between study arms in volume changes of the non-treated lobes by CT scan
Time frame: 6 months
To estimate the difference between study arms in residual volume
Time frame: 6 months
To estimate the difference between study arms in FEV1
Time frame: 6 months
To estimate the difference between study arms in gas transfer
Time frame: 6 months
To estimate the difference between study arms in modified MRC dyspnoea score
Time frame: 6 months
To estimate the difference between study arms on a 6 minute walk test
Time frame: 6 months
To estimate the difference between study arms in disease specific health status
Time frame: 6 months
To estimate the difference between study arms in dynamic hyperinflation during cycle ergometry
Time frame: 6 months
To estimate the difference between study arms in changes in respiratory and quadriceps muscle strength
Time frame: 6 months
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 6 Feb 2012.
Related trials for Heterogeneous Emphysema
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.
Pallav Shah, MBBS, MD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intra-bronchial valve (Spiration IBV) in people with Heterogeneous Emphysema, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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 9 inclusion and 20 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 6 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To estimate the difference between study arms in volume changes of the treated lobe(s) by CT scan (time frame: 6 months). 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 6 Feb 2012.