Small Particle Steroids in Refractory Asthma (SPIRA)

• Change in sputum eosinophil count over the trial period [ Time Frame: 0 weeks (start), 8 weeks (finish) ] [ Designated as safety issue: No ]
  Sputum will be processed for a differential cell count, with the primary outcome the difference in sputum eosinophil count between active and placebo groups at 8 weeks
  
  

• Change in alveolar nitric oxide level over the trial period [ Time Frame: 0 weeks (start), 4 weeks, 8 weeks (finish) ] [ Designated as safety issue: No ]
  alveolar nitric oxide has been shown to correlate with eosinophil count on BAL samples. Measured by measuring exhaled nitric oxide at multiple flow rates.
  
  
• Change in bronchial nitric oxide level [ Time Frame: 0 weeks (start), 4 weeks, 8 weeks (finish) ] [ Designated as safety issue: No ]
  Measured by single flow exhaled nitric oxide at 50 ml/s
  
  
• Change in prebronchodilator FEV1 [ Time Frame: 0 weeks (start), 4 weeks, 8 weeks (finish) ] [ Designated as safety issue: No ]
  Prebronchodilator FEV1 and FVC will be recorded with a Vitalograph Wedge Bellows spirometer
  
  
• Change in Juniper Asthma Control Questionnaire (ACQ) score [ Time Frame: 0 weeks (start), 4 weeks, 8 weeks (finish) ] [ Designated as safety issue: No ]
  UK English Version 2001
  
  
• Change in Juniper Asthma Quality of Life Questionnaire (AQLQ) score [ Time Frame: 0 weeks (start), 4 weeks, 8 weeks (finish) ] [ Designated as safety issue: No ]
  Self-administered United Kingdom Version 1994
  
  
• Use of oral steroid over the trial period [ Time Frame: 0-8 weeks ] [ Designated as safety issue: No ]
  Dose and duration of any additional oral corticosteroid will be documented
  
  
• Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: 0-8 weeks ] [ Designated as safety issue: Yes ]
  Adverse events will be recorded throughout the trial period
  
  

We have identified a group of patients with refractory asthma who have ongoing eosinophilic airway inflammation despite high dose inhaled corticosteroids.

Traditional inhaled steroids have a relatively proximal airway distribution which may lead to inadequate treatment of the distal airways.

We aim to demonstrate that a steroid inhaler with a smaller particle size which targets the distal airways can be a useful additional treatment option in this group of patients.