Table 1

Study plan

Phase 1: Run-in/steroid withdrawalPhase 2: Steroid trial
14 day run-inSteroid withdrawal till LOC or 28 daysScreening for progression to phase 2*Fluticasone 500 μg bd 28+ days
Visit123.1(3.2)(3.3)3.44.14.2
Clinical assessment×
Skin prick testing×
Feno×××
Spirometry×××××××
Bronchodilator response×××
Blood tests including IgE×
ACQ, ACT, AQLQ×××
HS challenge×
Sputum induction××
Methacholine challenge×
AMP challenge××
Diary×××
  • * See text for further details regarding progression through screening visits and criteria for progression to phase 2.

  • Steroid-naïve subjects progressed immediately from visit 1 to visit 3.1.

  • ACQ, Asthma Control Questionnaire; ACT, Asthma Control Test; AQLQ, Asthma Quality of Life with Standardised Activities; AMP, adenosine monophosphate; Feno, fraction of exhaled nitric oxide; HS, hypertonic saline; IgE, immunoglobulin E; LOC, loss of control.