Healthy volunteers, Effects of helium on the immune system ex vivo
Conditions
Interventions
Trade Name: Heliox21
Product Name: Heliox21
Pharmaceutical Form: Inhalation gas
Pharmaceutical form of the placebo: Inhalation gas
Route of administration of the placebo: Inhalation use
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Non-smoking, healthy, male volunteers, aged 18-45 years, informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Smoking, current or in the past six months Alcohol or drug abuse Allergic reaction to medication in past medical history Chronic medication use that could influence the immune system Presence of any condition that could influence the immune system
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effects of helium inhalation on the immune system of healthy volunteers.;Secondary Objective: ;Primary end point(s): The main parameters of this study will be proinflammatory cytokines determined after ex vivo stimulation of whole blood. The cytokines are: IL-1beta, IL-6, TNF-alpha, the chemokine IL-8, T-cell products IL-2 and INF-? and a neutrophil degranulation product: elastase. | — |
Countries
Netherlands
Outcome results
None listed