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This randomised, three arm, parallel, year long study compared the treatment of mild persistent asthma with budesonide 200 μg bd, zafirlukast 20 mg bd, or no controller therapy. All patients were given a symptom based asthma treatment plan advising them to use open label budesonide or oral prednisone when their symptoms worsened. Patients had physician diagnosed asthma, and mild persistent disease was defined as self-treatment with β agonists more than two days per week, night time awakenings related to asthma more than two days per month, or peak flow (PEF) variability of 20–30%. Exclusion criteria included active smoking, respiratory tract infection or corticosteroid use in the previous 6 weeks, hospital admission or two or more emergency department visits for asthma in the previous year, or any features of moderate persistent asthma.
There was no significant difference in the primary outcome of change in morning PEF between the three groups. There were also no significant differences in the number of asthma exacerbations or in the asthma related quality of life scores. Patients treated with regular budesonide had 26 additional symptom-free days per year, a higher pre-bronchodilator FEV1, lower percentage of sputum eosinophils, lower exhaled nitric oxide levels, and higher asthma control scores than the two other groups. Although not powered as a non-inferiority study, these data suggest overtreatment of some patients with mild persistent asthma, with unnecessary exposure to the side effects of these drugs and additional healthcare expenditure. Providing patients with symptom based treatment plans individually tailored to the severity of their disease permits asthma control with a minimum of medication.