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
Germany, Israel100 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 range
40 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in group mean post bronchodilator Forced Exhalation Volume in one second (FEV1)