Primary:1) Feasibility: Evidence of targeted lung volume reduction (TLVR) on CT scan at 6 weeks and 3 months follow up after endobronchial valve placement.Secondary:2) Safety: The number and type of procedure-related (Serious) Adverse events within…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility:
A) Being able to access the region of the fissure defect
B) Evidence of targeted lung volume reduction (TLVR >563 ml) on CT scan at 6
weeks and 3 months 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.
- Conversion of CV(+) into CV(-) lobes
Background summary
In patients with severe emphysema, bronchoscopic lung volume reduction (BLVR)
with endobronchial valves (EBV) can result in a very pronounced treatment
effect. 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 (10-30%)
with emphysema have no CV. 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 for patients with emphysema and collateral ventilation, which
have proven that sealing compounds can be delivered to the lung. Such a
compound is AeriSeal, of which is shown that it can be administered in the
lungs safely and can achieve lung volume reduction. 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 AeriSeal
to close off collateral channels and then proceed with EBV therapy to induce
lobar collapse, and thus maximal treatment effect.
Study objective
Primary:
1) Feasibility: Evidence of targeted lung volume reduction (TLVR) on CT scan at
6 weeks and 3 months follow up after endobronchial valve placement.
Secondary:
2) Safety: The number and type of procedure-related (Serious) Adverse events
within 3 months after the endobronchial valve placement and AeriSeal
administration
3) Effectiveness: a) Change in TLVR, lung function, exercise capacity and
quality of life at 3 months Follow Up. b) Conversion of CV(+) into CV(-) lobes
Study design
Prospective, single arm, open label intervention study.
Intervention
1. Transbronchial or transparenchymal injection of AeriSeal into the interlobar
collateral ventilation channels region to convert CV(+) lobes into CV(-) lobes.
2. Treatment with endobronchial valves.
Study burden and risks
This study is the first to investigate the feasibility of closing the
collateral ventilation channels by AeriSeal to convert positive collateral
ventilation to negative collateral ventilation. Therefore, it is possible that
the patients will not receive any benefit 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 the transbronchial
administration of AeriSeal include infective COPD exacerbation and pneumonia.
The patients who will participate in this trial have limited treatment options.
Due to the phenotype of the COPD and emphysema with incomplete fissures there
are no other possible regular bronchoscopic interventions at the moment.
Patients will only be offered entry into the MIND THE GAP CROSSING BORDERS
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 injection of AeriSeal could potentially successful convert CV(+)
to CV(-) and consequently the patient can be 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 9713 GZ
NL
Hanzeplein 1
GRONINGEN 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1. Diagnosis of emphysema
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 <= 50% predicted.
5. RV >= 175% predicted, and TLC >= 100% predicted and RV/TLC >= 55% predicted.
6. 6MWD >= 140 meters.
7. Dyspnea score of >=2 on the mMRC scale of 0-4.
8. Non-smoker > 6 months prior to signing the informed consent.
9. Chartis CV positive between target and ipsilateral lobe
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. Subject has DLCO <20% of predicted.
5. Myocardial infarction or other relevant cardiovascular events in the past 6
months.
6. Prior lung surgery, Lung volume reduction surgery, lung transplantation,
lobectomy, or pneumonectomy.
7. Prior endoscopic lung volume reduction.
8. Unstable pulmonary nodule requiring follow-up
9. Pregnant of nursing women.
10. Hypercapnia defined by PaCO2 > 8.0kPa, or Hypoxemia defined by PaO2 <
6.0kPa, both measured on room air.
11. Any disease with high probability of mortality within 24 months.
12. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant
therapy (such as LMWH or coumarins).
13. Patient was involved in other pulmonary drug studies within 30 days prior
to this study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04256408 |
| CCMO | NL72194.042.20 |