The Treatment of Adrenal Crisis With Inhaled Prednisolone
Recruiting
University Medical Center Groningen
Early Phase 1
2022-11-03
Rationale: An adrenal crisis is an acute life-threatening event which may occur in patients
with adrenal insufficiency. The initial emergency treatment consists of an intramuscular
injection with 100 mg hydrocortisone administered by the patient or a bystander. The
injection should be administered immediately. Although it is considered life-saving, it is
not very patient-friendly, because of the several steps required for reconstitution, the
intramuscular injection, the frequent presence of needle phobia, and pain at the injection
site. Inhalation of predniso(lo)ne could be a more patient-friendly alternative.
Objective: This study investigates the pharmacokinetics of nebulized prednisolone in two
different dosages.
Study design: Single-center, open-label study Study population: Healthy participants aged
18-75 years. Intervention (if applicable): Healthy volunteers receive a lower dose of
nebulized prednisolone (46.75 mg).After a wash-out period of at least one week, each
volunteer receives a higher dose of nebulized prednisolone (93.5 mg).
Main study parameters/endpoints: To establish the time from nebulizing to maximum
prednisolone concentration in serum and the area under the curve of prednisolone.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: Participants are exposed to a single supraphysiological dose of glucocorticoids
on two separate occasions. The risk of SAE is very limited. There is a small risk of an AE
during blood sampling. If it is demonstrated that therapeutic plasma concentrations of
prednisolone can be reached by nebulizing prednisolone, we intend to use the pharmacokinetic
data to design and perform a clinical study with a dry-powder micronized prednisone
inhalation. This would represent a novel and promising alternative treatment for an adrenal
crisis. Patients with adrenal insufficiency could then be offered a much more
patient-friendly and reliable alternative for intramuscular hydrocortisone injection.
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