Randomised, placebo-controlled, double-blinded, four-way crossover trial to demonstrate the comparative pharmacodynamic equivalence of a non-invasive diagnostic test for adrenal insufficiency in a healthy population: the STARLIT-2 study protocol

STARLIT-2 Study Overview

Introduction

Cortisol is a vital hormone for managing stress. When the body fails to produce enough cortisol, it leads to a condition called adrenal insufficiency (AI), which can be life-threatening. The current test for diagnosing AI, the Short Synacthen Test (SST), is invasive and costly. There is a need for a non-invasive and affordable alternative. The STARLIT-2 study is testing a new nasal spray called Nasacthin, which measures cortisol levels in saliva instead of blood.

Study Design

The STARLIT-2 study is a well-structured clinical trial involving 32 healthy adults and children. Participants will receive four different treatments (two active drugs and their placebos) across four visits. Blood and saliva samples will be collected at various times to measure cortisol levels. The main goals are:

  • To compare cortisol levels 30 minutes after taking Synacthen or Nasacthin.
  • To see if Nasacthin is as effective as Synacthen.
  • To determine how many participants have increased cortisol levels after using Nasacthin.

Ethics and Results Sharing

The study has received ethical approval and will share results through scientific journals and conferences. Participants will also receive feedback after the study.

Trial Registration

Trial Registration Number: ISRCTN62724177

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