Comparison of two tapering regimens in the management of glucocorticoid withdrawal - the PRED-STOP trial

Phase 4

• Conditions: asthma; glucocorticoid-responsive dermatological conditions; rheumatoid arthritis; polymyalgia rheumatica; pituitary-adrenal axis suppression; Metabolic and Endocrine - Other metabolic disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders; Respiratory - Asthma; Skin - Dermatological conditions

• Registration Number: ACTRN12621000614897
• Lead Sponsor: A/Prof W Inder - Investigator initiated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-21
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

•Age 18 years or over
•Able to give written informed consent
•Medical condition which has required supraphysiological glucocorticoid therapy:
oPrednisolone dose (or equivalent) greater than or equal to 5 mg daily for 6 or more weeks
oDexamethasone greater than or equal to 0.5 mg daily for 6 or more weeks
•Pre-dose morning cortisol <200 nmol/L
•Managing clinician has clinical intent to cease glucocorticoids completely

Exclusion Criteria

•Condition requiring lifelong chronic glucocorticoid use
•Known pathological pituitary or adrenal dysfunction
•Active malignancy
•Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent of participants with normal pituitary-adrenal function <br>•defined as passing short Synacthen test (SST) (60 minute cortisol >500 nmol/L)<br>[12 weeks post commencement of study drug]

Secondary Outcome Measures

Name	Time	Method
•Time (weeks) from commencement of study drug to passing short Synacthen test (60 minute cortisol >500 nmol/L)[up to 1 year (52 weeks) from commencement of study drug<br>pituitary-adrenal function will be assessed every 8 weeks from week 12 to week 52, up until the point where the participant passes the short Synacthen test<br>ie week 20, week 28, week 36, week 44, week 52. <br>If participant passes at week 28, the next assessment is at study exit, week 52.];•Quality of life and fatigue<br>Addison's disease specific Quality of Life score (AddiQoL)<br>Chalder Fatigue Scale<br><br>[12 weeks and 52 weeks post commencement of study drug];•Percent of participants with normal pituitary-adrenal function defined as passing a short Synacthen test (SST) (60 minute cortisol >500 nmol/L)[1 year post commencement of study drug]