Clinical Trials Logo

Clinical Trial Summary

Rationale: Case reports describe suppression of the hypothalamic-pituitary-adrenal (HPA) axis caused by local corticosteroids, most often with inhalation corticosteroids. The exact prevalence is not known. Early recognition is important, because suppression of the HPA-axis can lead to significant morbidity and mortality. Suppression of the HPA axis might occur more often when a Cytochrome P450 3A4 (CYP3A4) inhibitor, e.g. ritonavir, is used next to the local corticosteroid, a combination often used by human immunodeficiency virus (HIV)-patients. Cortisol can be determined in hair. This non-invasive analysis could help in diagnosis of suppressed HPA-axis.

Research questions:

Primary objective:

1. How often do inhalation or nasal corticosteroids lead to suppression of the HPA- axis in HIV-treated patients?

Secondary objectives:

2. Are other variables associated with the HPA-axis suppression?

3. Are cortisol measurements in hair as reliable as serum cortisol or an Adrenocorticotropic hormone (ACTH) stimulation test to diagnose suppression of the HPA axis? Study design: cross-sectional explorative study Study population: adults treated for HIV and using an inhalation or nasal corticosteroid.

Intervention: an ACTH stimulation test, cortisol measurements in blood and hair.

Main study parameters/endpoints:

Proportions of persons with a low morning plasma cortisol or low cortisol after an ACTH stimulation test. Correlation between cortisol in plasma and hair cortisol.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Each person will be screened with a history and a short physical examination. A venous cannula will be inserted for obtaining blood for the plasma cortisol and for the ACTH stimulation test. An ACTH stimulation test has no major complications. A piece of hair is cut for cortisol hair analysis. The risks and burden are minimal, while the future benefits could be great since suppression of the endogenous HPA- axis can be associated with morbidities like hypertension or osteoporosis and can even lead to an adrenal crisis when the local corticosteroid is stopped.


Clinical Trial Description

n/a


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT02501486
Study type Interventional
Source Radboud University
Contact F Besemer
Phone 0031243614599
Status Recruiting
Phase N/A
Start date July 2015
Completion date February 2017

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT03282487 - Optimising Steroid Replacement in Patients With Adrenal Insufficiency Phase 4
Not yet recruiting NCT05716607 - Treatment Study in Patients Treated With Both Insulin & Hydrocortisone N/A
Not yet recruiting NCT06435481 - Tolerability and Acceptance of Two Oral Hydrocortisone Compounding Formulation for Pediatrics Phase 4
Recruiting NCT03399383 - Adherence in Chronic Adrenal Insufficiency N/A
Completed NCT01428336 - Value of 25 mcg Cortrosyn Stimulation Test N/A
Completed NCT00851942 - Determination of Method-specific Normal Cortisol and Adrenal Hormone Responses to the Short Synacthen Test Phase 4
Withdrawn NCT00368381 - Hydrocortisone Versus Hydrocortisone Plus Fludrocortisone for the Treatment of Adrenal Insufficiency in Severe Sepsis Phase 4
Active, not recruiting NCT04519580 - Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
Recruiting NCT06008184 - Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids
Completed NCT03013166 - THIN Database Study: Resource Use and Outcomes in Patients With Adrenal Insufficiency Prescribed Hydrocortisone: Immediate, or Modified Release, or Prednisolone
Enrolling by invitation NCT02282150 - Modified-release Compared to Conventional Hydrocortisone on Diurnal Fatigue in Secondary Hypoadrenalism Phase 4
Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease
Completed NCT03000231 - Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency
Completed NCT01960530 - An Investigational Study of Hydrocortisone Phase 1
Completed NCT00552487 - Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis N/A
Completed NCT00575341 - Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency Phase 3
Completed NCT00471900 - Six Months DHEA Treatment in Female Adrenal Failure N/A
Completed NCT03294876 - Rheumatoid Arthritis Adrenal Recovery Study
Completed NCT03709381 - Effect of Adrenocorticotropic Hormone on Vascular Endothelial Growth Factor Release in Children Study Early Phase 1
Recruiting NCT05639127 - The Treatment of Adrenal Crisis With Inhaled Prednisolone Early Phase 1