Novel treatment of adrenal crisis: an early clinical trial with nebulized prednisolone

Novel treatment of adrenal crisis: an early clinical trial with nebulized prednisolone - The treatment of adrenal crisis with inhaled prednisolone

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51709

Enrollment

Registered

2022-10-06

Start date

2022-10-06

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal insufficiency

Interventions

Every subject receives a lower dose of nebulized prednisolone. After a wash out of one week, every subject receives a higher dose of nebulized prednisolone.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Age: 18 - 75 years • Woman who use reliable contraceptives or with a negative pregnancy test • Equal sex distribution

Exclusion criteria

Exclusion criteria: • Heart failure • Known liver or kidney disease • Dependency on glucocorticoids • Adrenogenital syndrome • Infectious disease • Uncontrolled hypertension defined as a blood pressure > 180/110 mmHg • Pregnancy or breastfeeding • Use of medication that interferes with cytochrome P450 (e.g. carbamazepine)

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters: Tmax and AUC	—

Secondary

Measure	Time frame
Other pharmacokinetic parameters Renal clearace of prednisolone	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)