NeSST2: The Development of a Noninvasive Short Synacthen Test

What Was Tested

This registered phase 2 trial tested Cosyntropin.

Recently there has been concern about the effect of inhaled steroids, routinely used in the treatment of asthma, on the body's ability to produce its natural stress hormone cortisol.

It had two arms (groups): Arm 1 (active comparator) and Arm 2 (experimental).

Nasal Synacthen.

The registry classes the interventions as drug.

More on the Plan

The success of the nasal administration of a novel formulation of Synacthen to adults was the first step in a work-stream, which aims to develop the clinical applicability of the non-invasive SST in addition to using it as an important research tool.

The invasive nature of the current diagnostic test makes large cohort research impracticable.

The researchers will do intra-individual variation work also.

This work is ongoing in collaboration with ACTH assay experts at the University of Manchester.

Who Took Part

The registry lists 12 planned participants were the target.

It was open to men only aged from 6 months up to 60 years.

Healthy volunteers could join, not only people with the condition.

The full record lists 0 inclusion and 15 exclusion criteria; among the exclusions: past or present history of an endocrinopathy (all stages); past or present history of asthma (stages 1b+c,2,3); past or present history of allergic rhinitis (stages 1b+c,2,3).

How the Study Was Run

The set-up was randomized, single-group and open-label.

Random assignment meant chance, not the researchers, decided who got Cosyntropin and who got the comparison, which limits bias.

Nothing was hidden in this open-label Cosyntropin study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-10-12 with completion listed for 2025-12-01.

It ran at 1 site in United Kingdom.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Peak plasma cortisol concentration (Cmax) (time frame: 6 months). Time of peak plasma cortisol concentration (Tmax) (time frame: 6 months). Bioavailability of nasal Synacthen (compared to IV Synacthen) (time frame: 6 months).

It also tracked 2 secondary outcomes, for example Tolerability and acceptability of nasal Synacthen test and Correlation of plasma cortisol with salivary cortisol.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cosyntropin in 12 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cosyntropin compound page, all human trials.