Inhaled steroid as rescue therapy for patients with adrenal insufficiency: INSTAR

• Research type

  Research Study

• Full title

  Inhaled steroid as rescue therapy for patients with adrenal insufficiency: INSTAR study

• IRAS ID

  1011661

• Contact name

  Simon Pearce

• Contact email

  simon.pearce@ncl.ac.uk

• Sponsor organisation

  Newcastle upon Tyne NHS Foundation Trust

• ISRCTN Number

  ISRCTN88499808

• Research summary

  Patients living with adrenal insufficiency have to take daily steroid replacement medications for survival. In healthy people any stress on the body leads to an increase in production of the steroid stress hormone cortisol by the adrenal glands. However, in patients with adrenal insufficiency this ‘reflex’ release of cortisol is missing, which can lead to a life-threatening mismatch in the body’s requirement for cortisol, known as adrenal crisis. The standard treatment for adrenal crisis is an emergency steroid injection, however, these injections are not always administered in time, leading to death or prolonged hospitalisation. For many patients there is reluctance or logistical delay, or the patient is too young or inexperienced to take agency for their own health with an injection that is a significant step out of their ‘comfort zone’.
  One way round this problem could be to use an alternative route to administer the emergency dose of steroids. It is already known that steroid inhalers which are used all the time for asthma treatment may administer enough steroid through the mouth and lungs to have an effect on the rest of the body, so this might be a good approach. This project will entail 3 small studies (with 30 ambulant patients in total) that will aim to to operationalise inhaled steroids as a ‘rescue’ treatment to prevent or treat adrenal crisis in patients with steroid insufficiency, so this could be used in everyday NHS practice. Ultimately, this could mean that a patient with adrenal insufficiency carries an inhaler in their handbag/pocket for emergency use rather than a needle, syringe and a glass vial of steroid medication. Treating adrenal crisis earlier would inevitably reduce hospitalisations, save lives and also remove a large psychological burden from patients with adrenal insufficiency, many of whom fear that they might become suddenly ill with adrenal crisis.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  25/NE/0087

• Date of REC Opinion

  20 May 2025

• REC opinion

  Further Information Favourable Opinion