Modified-release Compared to Conventional Hydrocortisone on Diurnal Fatigue in Secondary Hypoadrenalism
Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
Despite optimized hydrocortisone replacement regimes, many patients with adrenal
insufficiency (AI) suffer from impaired quality of life (QoL). Characteristically, patients
report high fatigue levels at certain times during the day. A modified-release hydrocortisone
has been shown to improve QoL, particularly fatigue, in patients with primary AI. However, it
is unknown, if the same effect can be observed in patients with secondary AI. Further, no
studies have evaluated the effect, taking into account the diurnal variation of fatigue. A
novel survey method termed Ecological Momentary Assessments (EMA) has the potential to
provide reliable measurements of diurnal variations in patient-reported outcomes, such as
fatigue. We will compare the effect of modified-release compared to conventional
hydrocortisone on fatigue in patients with secondary AI due to pituitary disease, and hereby
assess the feasibility of EMA as outcome in future large-scale randomised clinical trials
(RCTs).