A randomised 6-month study compared two maintenance doses of budesonide/formoterol (Symbicort® Turbuhaler® (h) maintenance and reliever therapy (Symbicort SMART®), 160/4.5 μg 1 × 2 and 2 × 2, in 8053 asthmatics with symptoms despite treatment with inhaled corticosteroids ± inhaled long-acting β2-agonists. This analysis compared response to the two treatments in elderly patients, ≥ 65 years, with that in younger patients. Elderly patients with early- or late-onset asthma were also compared. Elderly patients had lower post-bronchodilator FEV1 percentage predicted normal at baseline than younger patients (85.6% vs. 91.0%, respectively). The elderly had more exacerbations and risk of first severe exacerbation was increased by 55.3% (hazard ratio 1.553; 95% confidence interval: 1.249-1.931, p < 0.0001). However, no differences in exacerbations were seen between 1 × 2 or 2 × 2 budesonide/formoterol maintenance and reliever therapy treatment in the elderly. Five-item Asthma Control Questionnaire (ACQ-5) scores improved equally in the two age groups. Changes in mean ACQ-5 scores between 1 × 2 and 2 × 2 were significant in both age groups but not clinically relevant (≥ 65 years, 0.12; p = 0.018; <65 years, 0.09; p < 0.0001). Elderly patients with early- and late-onset asthma responded equally well to treatment. Budesonide/formoterol maintenance and reliever therapy (1 × 2 or 2 × 2) is an effective, well-tolerated and practical treatment concept in elderly and younger asthmatic patients.
Trial registration: ClinicalTrials.gov NCT00463866.
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