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

Phase 1

• Conditions: Adrenal insufficiency; MedDRA version: 20.0Level: PTClassification code 10001367Term: Adrenal insufficiencySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2018-001502-28-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-08
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 55

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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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, aminogluethimide, itraconazole, ketoconazole, ciclosporin or ritonavir.

•Pregnancy, taking the 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified