Activation of Apoptosis-related Receptors on Alveolar Macrophages (NCT04775394) | Clinical Trial Compass
CompletedNot Applicable
Activation of Apoptosis-related Receptors on Alveolar Macrophages
Germany28 participantsStarted 2021-01-01
Plain-language summary
The aim is to understand whether activation of receptors involved in clearance of apoptotic cells will improve efferocytosis in COPD patients in vitro and whether generation of pro-inflammatory cytokines can be decreased in COPD patients.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion Criteria:
Healthy volunteers
* Able and willing to give written informed consent.
* Healthy male and female subjects, aged 18-80 years for the initial part and 40-80 years for the main part, inclusive. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs) or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
* Normal lung function with Forced Expiratory Volume in 1 second (FEV1) predicted ≥ 80% and FEV1/Forced Vital Capacity (FVC) \> 70%.
* Body mass index between 18 and 32 kg/m2
* Ex-smokers since at least 12 months with a smoking history of at least 10 pack years.
* Abl…
What they're measuring
1
Percentage of pH-Rhodo-positive alveolar macrophages
Timeframe: Ex-vivo, after collection of bronchoalveolar lavage (BAL) on Day 1