Collateral Ventilation Effects on Response to AeriSeal System Treatment in Upper Lobe Predominant… (NCT01520740) | Clinical Trial Compass
TerminatedPhase 4
Collateral Ventilation Effects on Response to AeriSeal System Treatment in Upper Lobe Predominant Emphysema
Germany100 participantsStarted 2012-02
Plain-language summary
This study will evaluate the effects of baseline collateral ventilation status on outcomes following treatment with AeriSeal System in patients with advanced upper-lobe predominant heterogenous emphysema.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing and able to provide informed consent and to participate in the study
* Age \> or = 40 years at the time of the screening
* Advanced upper lobe predominant emphysema by CT scan
* Two (2) subsegments appropriate for treatment based upon CT scan in 2 different upper lobe segments in each lung (total 4 available subsegments)
* MRCD questionnaire score of 2 or greater at screening
* Failure of medical therapy to provide relief of symptoms
* Spirometry 15 minutes after administration of bronchodilator (BOTH):
* FEV1 \< 50% predicted
* FEV1/FVC ratio \< 70%
* Lung volumes by plethysmography (BOTH):
* TLC \> 100% predicted
* RV \> 150% predicted
* DLco \> or = 20 and \< or = 60% predicted
* Oxygen saturation (SpO2) \> 90% on \< or = 4 L/min supplemental O2, at rest
* Six-Minute Walk Test distance \> or = 150 m
* Abstinence from smoking for at least 16 weeks prior to screening
Exclusion Criteria:
* Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
* Requirement for ventilator support (invasive or non-invasive)
* Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks of Screening visit
* α-1 antitrypsin serum level of \<80 mg/dl (immunodiffusion) or \<11µmol/L (nephelometry) at Sc…
What they're measuring
1
Change from baseline in group mean post bronchodilator Forced Exhalation Volume in one second (FEV1)