Safety and Efficacy of Prednisolone in Adrenal Insufficiency Disease (PRED-AID Study)

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study compares low-dose prednisolone therapy against standard regimens of hydrocortisone therapy for the treatment of adrenal insufficiency (AI). AI is a condition in which, individuals are unable to sufficiently produce the natural stress hormone, cortisol.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Collaborators: Imperial College Healthcare Charity; Imperial Health Charity; National Institute for Health Research, United Kingdom
• Treatments: Epinephrine; Epinephryl borate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Racepinephrine

Criteria

Inclusion Criteria:

• Aged 18 - 70 years

• Male or female

• Diagnosed with AI for over 6 months according to standard diagnostic criteria

• Established on stable HC replacement or prednisolone replacement, dose not altered for at least 3 months

• Established on a stable dose of Fludrocortisone, if taking, dose not altered for at least 3 months

• Participants taking other hormone replacements (e.g. levothyroxine, testosterone or growth hormone in secondary adrenal insufficiency) are accepted providing that their replacement doses have not altered for at least 3 months

• Participants who are otherwise healthy enough to participate, as determined by pre-study medical history and physical examination.

• Participants who are able and willing to give written informed consent to participate in the study.

Exclusion Criteria:

• Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus.

• Unable to give informed consent.

• Taking supplements or herbal medications that the participant is unwilling or unable to stop prior to and during the study period e.g. St John's Wort (may decrease prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties).

• Currently taking medications that alter CYP3A4 metabolism of glucocorticoids that the participant is unwilling or unable to stop prior to and during the study period e.g. phenytoin, phenobarbital, rifampicin, rifabutin, carbamazepine, primidone, aminoglutethimide, itraconazole, ketoconazole, ciclosporin or ritonavir.

• Pregnancy, taking the combined oral contraceptive pill, or oral oestrogen replacement therapy due to the effects on cortisol binding globulin levels and determination of prednisolone levels. Transdermal oestrogen replacement is permitted.

• Diagnosis of congenital adrenal hyperplasia, untreated