Trial | NCT03936517  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    44
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.
Steroid replacement therapy is vital for the health of patients with adrenal insufficiency (AI), who are unable to produce the natural stress hormone, cortisol. The objectives of steroid replacement therapy are to replace the body's physiological requirements for cortisol without over-replacement and consequent Cushing's syndrome. Equally, under-replacement presents the risk of patients experiencing potentially fatal Addisonian crises.

Appropriately replacing a patient's steroid requirement is a significant challenge. Hydrocortisone (HC) is used in the majority of patients with AI in the UK. However, HC has a short duration of action, necessitating dosing 3 times a day. Low-dose prednisolone (PR) is an alternative to HC which needs only once-daily. There have been no studies directly comparing low-dose PR to HC treatment.

This is a two-arm, two-period, double-blind, randomised, cross-over study comparing the low dose PR and standard regimens of HC in the treatment of AI.
Study Started
Jul 31
2019
Primary Completion
Feb 01
2025
Anticipated
Study Completion
Feb 01
2025
Anticipated
Last Update
Sep 01
2023

Drug Prednisolone

Low dose prednisolone for the treatment of adrenal insufficiency. Usually administered once daily

Drug Hydrocortisone

Standard regimens of hydrocortisone for the treatment of adrenal insufficiency. Usually administered thrice daily.

Prednisolone first; hydrocortisone second Other

Participant will receive 4 months of prednisolone in the first study period and 4 months of hydrocortisone in the second study period.

Hydrocortisone first; prednisolone second Other

Participant will receive 4 months of hydrocortisone in the first study period and 4 months of prednisolone in the second study period.

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
No Results Posted