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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03936517

Recruitment Status Recruiting

First Posted May 3, 2019

Last update posted August 14, 2019

Study Description

Brief 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.

  • Condition or Disease:Adrenal Insufficiency
  • Intervention/Treatment: Drug: Prednisolone
    Drug: Hydrocortisone
  • Phase: Phase 3
Detailed Description

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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 44 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Intervention Model Description: Two-arm, two-period, double-blind randomised crossover study
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Safety and Efficacy of Prednisolone in Adrenal Insufficiency Disease (PRED-AID Study)
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: February 2023
  • Estimated Study Completion Date: February 2023
Arms and interventions
Arm Intervention/treatment
Other: Hydrocortisone first; prednisolone second
Participant will receive 4 months of hydrocortisone in the first study period and 4 months of prednisolone in the second study period.
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.
Other: Prednisolone first; hydrocortisone second
Participant will receive 4 months of prednisolone in the first study period and 4 months of hydrocortisone in the second study period.
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.
Outcome Measures
  • Primary Outcome Measures: 1. Change in concentration of Osteocalcin [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    Assesses bone health of each group by comparing total osteocalcin and undercarboxylated osterocalcin
  • Secondary Outcome Measures: 1. Change in concentration of P1NP [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    Assesses bone health of each group by comparing P1NP
  • 2. Change in concentration of BALP [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    Assesses bone health of each group by comparing BALP
  • 3. Change in concentration of NTX [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    Assesses bone health of each group by comparing NTX
  • 4. Heart Rate [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    recording observations- heart rate
  • 5. Systolic and diastolic blood pressure [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    recording observations- blood pressure
  • 6. Waist-Hip circumference [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    recording observations- Waist-Hip circumference ratios
  • 7. Change in concentration of Lipid profile (Total cholesterol, HDL, LDL and triglycerides) [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    measuring biochemical indicators of cardiovascular risk: total cholesterol, HDL, LDL and triglycerides
  • 8. Change in concentration of high sensitivity CRP [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    measuring biochemical indicators of cardiovascular risk: high sensitivity CRP
  • 9. Change in concentration of Glucose [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    measuring glucose
  • 10. Change in concentration of HbA1c [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    measuring HbA1c
  • 11. Infection rates and severity [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    assessed by completion of the German National Cohort Questionnaire (GNCQ). Frequency (None; 1; 2; 3; >3; Unknown) of 1. Upper respiratory tract infections; 2. Lower respiratory tract infections; 3.Gastroenteritis; 4. Mucosal infections; 5. Urinary tract infections; 6. Influenza; will be recorded. The frequencies of each type of infection will be compared between time points.
  • 12. Wellbeing assessed by completion the short form health survey [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    assessed by completion the short form health survey-36 (SF-36). Scores will be produced in each of 8 domains (Physical functioning, Role functioning/physical, Role functioning/emotional, Energy/fatigue, Emotional wellbeing, Social functioning, Pain, General Health and Health Change). Each domain is scored from 0 to 100, with higher scores suggesting more positive outcomes. Scores will be compared in each domain between time points.
  • 13. Wellbeing assessed by completion the Addi-QoL questionnaire [ Time Frame: Between Day 1 and Day 120 within each study period; and between Day 120 of Period 1 and Period 2. ]
    assessed by completion the Addi-QoL questionnaire. A total score between 30 and 120 is produced, with higher scores suggesting a more positive outcome. The score is compared between time points.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts

Contact: Sirazum Choudhury, MBBS BSc 07555717544 steroids@imperial.ac.uk

Locations

United Kingdom
Imperial College Healthcare NHS Trust
London

Sponsors and Collaborators

Imperial College London

National Institute for Health Research, United Kingdom

Imperial Health Charity

Investigators

Principal Investigator: Karim Meeran, MBBS BSc MD Imperial College London

More Information
  • Responsible Party: Imperial College London
  • ClinicalTrials.gov Identifier: NCT03936517 History of Changes
  • Other Study ID Numbers: 18IC4546, 2018-001502-28, 201045, ISRCTN41325341, 19/LO/0083
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: August 14, 2019
  • Last Verified: August 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Imperial College London: Glucocorticoids
    Hydrocortisone
    Prednisolone
    Cortisol
  • Additional relevant MeSH terms: Adrenal Insufficiency