Does histamine control blood levels of adrenaline?

• Research type

  Research Study

• Full title

  Does histamine control the release of adrenaline (epinephrine) from the adrenal glands into the bloodstream

• IRAS ID

  252312

• Sponsor organisation

  TRIO Medicines Ltd

• Duration of Study in the UK

  0 years, 5 months, 2 days

• Research summary

  Adrenaline is a hormone produced by the adrenal glands. Stress increases release of adrenaline into the bloodstream, which prepares us for “fight or flight”. We aim to find out if histamine controls adrenaline release in humans.
  
  We’ll study 10 healthy men or women on two occasions, at least 9 days apart. We’ll give them a single injection of chlorpheniramine on one occasion and a single injection of placebo (dummy medicine that looks the same) on another occasion. Chlorpheniramine is a classical antihistamine (histamine H1-receptor antagonist) that’s been marketed for over 60 years for treatment of allergies. Its main side effect is drowsiness.

  Subjects will be admitted on the evening before the study day and will fast overnight. In the morning, they’ll rest quietly on their beds from 0730 h to 1400 h. First, we’ll insert a cannula into a vein on their forearm, take a blood sample from the cannula for subsequent measurement of adrenaline and noradrenaline (the precursor of adrenaline), take their blood pressure and heart rate, and ask them to make a mark on a 10 cm scale labelled “wide awake” at one end and “nearly asleep” at the other end (visual analogue scale, VAS). Then we’ll inject chlorpheniramine or placebo via the cannula. Over the next 6 h, we’ll collect eight more blood samples, for subsequent measurement of adrenaline and noradrenaline, and measure blood pressure and heart rate eight more times, and the subject will complete the VAS several more times.
  
  After completion of all the tests at 6 h after dosing, they’ll eat a meal, after which they can leave the ward, if all is well. We’ll check that they’re still well 5–7 days later. Participants will take about 2 weeks to finish the study.

  A pharmaceutical company (Trio Medicines Ltd) is funding the study.

• REC name

  Wales REC 2

• REC reference

  18/WA/0305

• Date of REC Opinion

  3 Oct 2018

• REC opinion

  Further Information Favourable Opinion