Small Particle Steroids in Refractory Asthma

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.

Inclusion criteria

• Age 18-80
• ACQ >1.5 or a requirement for oral steroids twice a year or more
• High dose inhaled steroid (>1000mcg BDP or equivalent)
• Treatment with or unsuccessful trial of:

• long-acting beta agonist
• leukotriene antagonist
• Sputum eosinophil count >3% despite high dose inhaled steroid or >2% with serum eosinophils >0.4x10exp9/l
• Clinical response to 2 weeks of oral prednisolone: (any one)

• reduction in ACQ by 0.5 or more
• increase in FEV1 by 200ml
• normalisation of exhaled nitric oxide or reduction of >25ppb

Exclusion criteria

• Current smoker, or ex-smoker for <12 months
• Current treatment with an extrafine steroid inhaler
• Respiratory infection within the last 4 weeks
• Pregnancy or lactation
• Poor compliance with usual asthma medication
• Clinical diagnosis of significant bronchiectasis
• Use of a medication which may interact with ciclesonide:

• ketoconazole or itraconazole
• ritonavir, nelfinavir