Primary objective: 1. To investigate the feasibility of injecting autologeous blood or blood derived products into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.Secondary…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility: Evidence of targeted lung volume reduction (TLVR) on CT scan at 1
month Follow Up.
Secondary outcome
Safety: The number and type of procedure-related (serious) adverse events
within 3 months after the procedure.
Effectiveness: Change in TLVR, lung function, exercise capacity and quality of
life at 3 months Follow Up.
Background summary
Of all current bronchoscopic lung volume reduction (BLVR) strategies the
endobronchial valve (EBV) approach can result in the most pronounced treatment
effects in patients with upper or lower lobe heterogeneous emphysema. This is
mainly due to the total lobar occlusion, resulting in a long volume reduction
of an entire lobe. However, EBV treatment is only this highly efficacious in
patients with absence of collateral ventilation (CV) between the treatment lobe
and the adjacent lobe(s). Only a minority of patients with emphysema have no
CV, with figures in patients with heterogeneous emphysema ranging from 10-30%.
Because the presence of CV is the 'bane' of the effect of EBV therapy, there
are a number of so called non-blocking techniques under development, which have
proven that sealing compounds can be delivered to the lung. Also BLVR efforts
with autologeous blood from countries where there is no access to devices or
just creative thinking is conducted, or the use of tissue-col or fibrin-glue to
try to treat fistulas, both show feasibility and safety of substance delivery
to the airways and lungs. A big step forward and great opportunity to improve
overall efficacy of BLVR is to combine treatment modalities aiming to close the
dependent collateral channels by using fluid substances to close off collateral
channels and then proceed with EBV therapy to induce lobar collapse, and thus
maximal treatment effect.
Study objective
Primary objective:
1. To investigate the feasibility of injecting autologeous blood or blood
derived products into the interlobar collateral ventilation channels region to
make the target lobe suitable for endobronchial valve treatment.
Secondary objectives:
2. To investigate the safety of injecting autologeous blood or blood derived
products into the interlobar collateral ventilation channels region to make the
target lobe suitable for endobronchial valve treatment.
3. To investigate the effectiveness of injecting autologeous blood or blood
derived products into the interlobar collateral ventilation channels region to
make the target lobe suitable for endobronchial valve treatment.
Study design
Prospective, single arm open label intervention study.
Intervention
The injection of autologeous blood or blood derived products into the
interlobar collateral ventilation channels region to convert CV(+) lobes into
CV(-) lobes.
Study burden and risks
This study is the first to investigate the feasibility of closing the
collateral ventilation channels by autologeous blood or blood derived products
to convert positive collateral ventilation to negative collateral ventilation.
Therefore, it is possible that the patients will not receive any benefits from
participation in this trial if the procedure will not lead to a conversion to
CV(-).
Risks associated with the Chartis measurement and the placement of EBVs mainly
include the risk associated with routine bronchoscopy, like sore throat and
bronchitis. The placement of the EBV is associated with an increased risk of a
pneumothorax. The specific risks to the use of blood or blood derived products
include infective COPD exacerbation and pneumonia.
The patients who will participate in this trial have limited treatment options.
Due to their type of emphysema and incomplete pulmonary fissures other
bronchoscopic lung volume reduction treatments are not possible. Patients will
only be offered entry into the MIND THE GAP trial if the consensus decision of
the bronchoscopic intervention is that participating in this trial is the best
option for the patient. Other trials have shown that bronchoscopy is a very
safe procedure in severe emphysema patients. The advantage of the use of
patient*s own blood is that it does not require foreign implants, and
represents dramatic cost savings. The injection of autologeous blood or blood
derived products could potentially successful convert CV(+) to CV(-) and
consequently the patient can be succesfully treated with the EBV. Potentially,
BLVR could result in the majority of patients in a clinical significant
increase in FEV1 and FVC, with decreasing RV, resulting in a significant
reduction in dyspnea and improvement in quality of life, and a better exercise
tolerance.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosis of upper or lower lobe heterogeneous emphysema with a difference in heterogeneity of >= 25% in destruction at -950HU between ipsilateral lobes.
2. Subjects of both genders of at least 35 years of age at the time of the baseline visit.
3. Understand and voluntarily sign a patient informed consent form.
4. 15 % predicted <= FEV1<= 45% predicted.
5. RV >= 175% predicted, and TLC >= 100% predicted and RV/TLC >= 55% predicted.
6. 6MWT >= 140 meters.
7. Dyspnea score of >=2 on the mMRC scale of 0-4.
8. Non-smoker > 8 weeks prior to signing the informed consent.
Exclusion criteria
1. Evidence of active pulmonary infection.
2. Evidence of clinically significant bronchiectasis.
3. History of more than 3 exacerbations with hospitalizations over the past 12 months.
4. Evidence of pulmonary hypertension (sPAP > 45mmHg).
5. Subject has DLCO <20% of predicted.
6. Myocardial infarction or other relevant cardiovascular events in the past 6 months.
7. Prior lung surgery, Lung volume reduction surgery, lung transplantation, lobectomy, or pneumonectomy.
8. Prior endoscopic lung volume reduction.
9. Unstable pulmonary nodule requiring follow-up.
10. Pregnant or nursing women.
11. Hypercapnia defined by PaCO2 > 8.0kPa, or Hypoxemia defined by PaO2 < 6.0kPa, both measured on room air.
12. >20mg prednisolon (or equivalent) use/days.
13. Any disease with high probability of mortality within 24 months.
14. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins).
15. Patient was involved in other pulmonary drug studies within 30 days prior to this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL47731.042.14 |
| Other | wordt tzt nog geregistreerd in het clinical trial register |
| OMON | NL-OMON23885 |