Ciliation and Mucus Rheology Parameters Determined Via Air-liquid-interface Cell Cultures in Non-… (NCT03187860) | Clinical Trial Compass
TerminatedNot Applicable
Ciliation and Mucus Rheology Parameters Determined Via Air-liquid-interface Cell Cultures in Non-smoking, Smoking, COPD and Asthmatic Patients
Stopped: Inclusions was stopped at 30 patients. Investigators did not wish to extend inclusions.
France30 participantsStarted 2019-06-19
Plain-language summary
This is a prospective study comparing 4 groups: (1) non-smoking controls, (2) smokers without chronic obstructive pulmonary disease (COPD), (3) smokers with COPD, (4) severe asthma.
Bronchial biopsy specimens from each subject will be obtained to produce air-liquid-interface cell cultures. These will then be used to make observations concerning cilia and mucus rheology.
This is a first pilot study. The working hypothesis is that the largest group differences will be found for cilia densities; the latter metric was thus chosen as a primary criterion.
Who can participate
Age range
18 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 for non smoking controls:
* The subject has given free and informed consent and signed the consent form
* The subject is affiliated with or beneficiary of a medical insurance program
* The subject has never smoked
* No obstructive breathing disorder (forced expiratory volume at one second (FEV1) \>70% of predicted value; the ratio of FEV1 to forced vital capacity (FEV1/FVC) is \> 0.7)
* No known respiratory disease
Inclusion criteria for smokers without COPD:
* The subject has given free and informed consent and signed the consent form
* The subject is affiliated with or beneficiary of a medical insurance program
* Smoker or former smoker (\>= 30 pack years)
* No obstructive breathing disorder (forced expiratory volume at one second (FEV1) \>70% of predicted value; the ratio of FEV1 to forced vital capacity (FEV1/FVC) is \> 0.7)
Inclusion criteria for smokers with COPD:
* The subject has given free and informed consent and signed the consent form
* The subject is affiliated with or beneficiary of a medical insurance program
* Smoker or former smoker (\>= 30 pack years)
* Subject presenting with COPD: FEV1/FVC \< 0.7 (based on spirometry values in the medical file and performed in the 3 months prior to inclusion)
* The subject requires bronchial fibroscopy (decision made by pneumologist)
* COPD of grade "2" or "3" according to GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease)
Inclusion criteria for subjects with severe asthma:
* T…
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
Surface density of active cilia
Timeframe: Day 0 + approximately 2 months of cell culture time