Rationale: A big step forward and great opportunity to improve overall efficacy of bronchoscopic lung volume reductioen is to combine treatment modalities aiming to close the dependent collateral channels and then proceed with EBV therapy to induce lobar collapse, and thus maximal treatment effect. Objective: Primary objective: 1. To investigate the feasibility of injecting AeriSeal 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 AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment. 3. To investigate the effectiveness of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Transbronchial or transparenchymal injection of AeriSeal into the interlobar collateral ventilation channels region to convert CV-positive lobes into CV-negative lobes.
University Medical Center Groningen
Groningen, Netherlands
feasibility - Target Lobar Volume Change on Chest -CT scan
To investigate the feasibility of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment
Time frame: 3 months
safety - Number and specification of reported (S)AEs per individual patient and as aggregate
To investigate the safety of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment. Thsi by collection of all adverse events, and specifically: death, pnuemothorax, pneumonia, COPD exacerbation, and post treatment inflammatory response.
Time frame: 3 months
changes in Quality of Life as measured by the SGRQ
By measuring the absolute change in The St George's Respiratory Questionnaire total score (0-100 points with higher scores indicating poor QOL)
Time frame: 3 months
effectiveness - Measurement of change in Forced Expiratory Volume in one second (FEV1).
By measuring changes in relative% in FEV1(L)
Time frame: 3 months
effectiveness - Measurement of change in Residual Volume (RV)
By measuring the change in absolute mL in RV
Time frame: 3 months
effectiveness - Measurement of changes in 6-minute walk test (6MWT)
By measuring the absolute change in meters in the 6MWT
Time frame: 3 months
changes in Quality of Life as measured by the COPD Assessment Test (CAT)
By measuring the absolute change in CAT score (0-40, with higher score indicating poor QOL)
Time frame: 3 months
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