Pooled patient data# | Randomised treatment | Geographic location | |||
All comparators | Budesonide/Formoterol maintenance plus reliever therapy | Northern hemisphere | Southern hemisphere | Tropics | |
Patients n | 7281 | 5226 | 8279 | 2644 | 1584 |
Males n (%) | 3030 (42) | 2161 (41) | 3628 (44) | 1092 (41) | 471 (30) |
Age yrs mean (range) | 39.0 (4–83) | 39.0 (4–89) | 39.7 (4–89) | 37.0 (5–83) | 40.2 (12–82) |
Entry ICS dose μg mean (range) | 709 (100–3200) | 715 (160–2000) | 705 (100–2400) | 730 (200–3200) | 714 (100–2000) |
Entry LABA use % | 44 | 47 | 48 | 40 | 39 |
Asthma diagnosis yrs median (range) | 11 (0–77) | 11 (0–70) | 9 (0–71) | 16 (1–71) | 13 (1–77) |
FEV1 % pred | 72.0±12.5 | 71.7±12.4 | 72.9±12.1 | 71.9±13.1 | 66.9±11.8 |
As-needed reliever use inhalations per day | 2.2±1.4 | 2.1±1.4 | 2.1±1.4 | 2.5±1.4 | 2.4±1.5 |
Total daily symptom score | 1.77±0.96 | 1.78±0.94 | 1.74±0.96 | 1.94±0.92 | 1.65±0.96 |
Data are presented as mean±sd, unless otherwise stated. Pooled baseline and demographic data for patients receiving budesonide/formoterol maintenance and reliever therapy, and pooled fixed dose maintenance treatments plus short-acting β2-agonists (SABA), and for all patients by geographic location. ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; FEV1: forced expiratory volume in 1 s; % pred: % predicted. #: the ICS/LABA plus formoterol as-needed arm in the study by Rabe et al. [23] was not included in the main pooled analysis. For demographic data, for each of the different treatment groups, refer to the individual references (higher maintenance dose of ICS plus SABA [21, 22]; same maintenance dose ICS/LABA plus SABA [22, 23]; higher maintenance dose ICS/LABA plus SABA [24, 25]; Budesonide/formoterol maintenance and reliever therapy [21–25]).