Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma

INTERVENTION: Trade Name: Alvesco 160 inhaler Product Name: Ciclesonide Pharmaceutical Form: Pressurised inhalation* CONDITION: Refractory Asthma ; MedDRA version: 12. Level: LLT Classification code 10003553 Term: Asthma PRIMARY OUTCOME: Main Objective: In patients with poorly controlled asthma with evidence of persistent eosinophilic inflammation can the addition of extra inhaled corticosteroid that targets the distal airways improve asthma control and reduce the eosinophilic airway inflammation?; ; The primary endpoint will be the difference in sputum eosinophil count between active and placebo groups at 8 weeks. Primary end point(s): The difference in sputum eosinophil count between active and placebo groups at 8 weeks. Secondary Objective: The secondary endpoints are differences in bronchial nitric oxide, alveolar nitric oxide, forced expiratory volume in 1 second (FEV1), blood eosinophil count, asthma symptoms, Asthma Control Questionnaire (ACQ) score, Asthma Quality of Life Questionnaire (AQLQ) score, number of exacerbations and use of oral steroid. INCLUSION CRITERIA: Non‐smokers with refractory asthma (ACQ score =1.5 or requirement for oral steroids =twice per year despite treatment with high dose inhaled steroid and treatment with, or unsuccessful trial of, a long acting beta‐2 agonist or leukotriene antagonist). Sputum eosinophil count >3% A response to a 2 week trial of oral steroids, defined as a reduction in ACQ score by 0.5, an increase in FEV1 of 200ml, or either normalisation or a fall in exhaled NO of =25 ppb. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range