NCT05639127: TRACER

The Treatment of Adrenal Crisis With Inhaled Prednisolone

Status unknown EARLY_PHASE1 Last updated 6 December 2022

What this trial tests

EARLY_PHASE1 trial testing Prednisolone in Adrenal Insufficiency in 12 participants. Status unknown.

Timeline

3 November 2022

Primary endpoint
30 November 2022

1 March 2023

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	3 November 2022
Primary completion	30 November 2022
Estimated completion	1 March 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• Prednisolone — full drug profile →

Conditions studied

• Adrenal Insufficiency — all drugs for Adrenal Insufficiency →

Sponsor

University Medical Center Groningen

Who can join

Adults 18 to 75, any sex, with Adrenal Insufficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.