In short
There is currently 1 ongoing clinical trial investigating treatment options for adrenal insufficiency. This trial focuses on patients who have developed glucocorticoid-induced adrenal insufficiency while being treated for inflammatory conditions with prednisolone. The study is examining whether additional hydrocortisone treatment can help improve quality of life and reduce fatigue during stressful periods.
Clinical trial locations
Study on Hydrocortisone for Stress in Patients with Polymyalgia Rheumatica or Giant Cell Arteritis and Adrenal Insufficiency
This clinical trial is being conducted in Denmark and focuses on a specific group of patients who have developed a condition called glucocorticoid-induced adrenal insufficiency. This happens when the body's adrenal glands don't produce enough cortisol, a vital hormone, because of long-term use of steroid medications like prednisolone. The patients in this study have polymyalgia rheumatica or giant cell arteritis, which are inflammatory conditions affecting muscles and blood vessels.
Main inclusion criteria: Participants must be at least 50 years old, with women being postmenopausal. They need to have a confirmed diagnosis of polymyalgia rheumatica, giant cell arteritis, or both, and must have been treated with prednisolone for at least 12 weeks. Currently, they should be taking a low daily dose of prednisolone between 0 and 5 mg, with the dose having been 5 mg or less for at least 2 weeks before joining the study.
Main exclusion criteria: The trial excludes patients who do not have glucocorticoid-induced adrenal insufficiency or who are not currently on low-dose prednisolone treatment. Those without a diagnosis of polymyalgia rheumatica or giant cell arteritis, people outside the specified age range, and vulnerable populations requiring special care are also excluded.
Focus and goals: The main goal of this trial is to determine whether additional treatment with hydrocortisone can improve quality of life, particularly by reducing feelings of tiredness and fatigue during times of physical or mental stress. The study is designed as a double-blind trial, meaning neither participants nor researchers know who receives hydrocortisone and who receives a placebo. This approach ensures unbiased results.
Participants will use a smartphone application to report their stress levels and complete fatigue assessments five times daily for three days during stressful periods. They will also undergo monthly evaluations using standardized questionnaires to assess their overall well-being. The trial monitors various health aspects including the duration of prednisolone treatment, symptoms related to adrenal insufficiency, body composition, bone quality, and metabolic health. Safety outcomes such as adrenal crises and hospitalizations are carefully tracked throughout the study, which is estimated to conclude by December 31, 2026.
Investigational drugs: The primary drug being tested is hydrocortisone, given as 10 mg tablets for oral use during mild to moderate stress periods. Hydrocortisone is a medication that mimics cortisol, helping the body manage stress more effectively. All participants continue their existing prednisolone treatment, which they are already taking for their underlying inflammatory conditions. The study aims to see whether adding hydrocortisone can better support patients during stressful situations when their bodies need more cortisol than their suppressed adrenal glands can produce.
Summary
Currently, there is only one ongoing clinical trial specifically addressing adrenal insufficiency, with a focus on a particular form of the condition caused by long-term steroid use. This trial is taking place in Denmark and represents an important investigation into how supplemental hydrocortisone therapy might benefit patients who have developed glucocorticoid-induced adrenal insufficiency while being treated for inflammatory rheumatic diseases. The study takes a patient-centered approach by focusing on quality of life improvements and practical symptom management during stressful periods, which are particularly challenging for people with this condition. The use of modern technology, such as smartphone applications for daily reporting, reflects contemporary approaches to clinical research and patient monitoring.
