TABLE 1

Studies included in the analysis

First author (study code) [ref.]	Duration months	BUD/FORM MART dosing regimen	Comparator(s)	Subjects^#
Rabe (SD-039-0667) [10]	6	BUD/FORM 80/4.5 μg, 2 inhalations once daily + as needed	BUD 160 μg, 2 inhalations once daily + terbutaline 0.4 mg as needed	Adults 588 (84) Adolescents 109 (16)
Scicchitano (SD-039-0668) [11]	12	BUD/FORM 160/4.5 μg, 2 inhalations once daily + as needed	BUD 160 μg, 2 inhalations twice daily + terbutaline 0.4 mg as needed	Adults 1769 (94) Adolescents 121 (6)
O’Byrne (SD-039-0673) [12] ^¶	12	BUD/FORM 80/4.5 μg, 1 inhalation twice daily + as needed	BUD/FORM 80/4.5 μg, 1 inhalation twice daily + terbutaline 0.4 mg as needed or BUD 320 μg, 1 inhalation twice daily + terbutaline 0.4 mg as needed	Adults 2103 (76) Adolescents 316 (12)
Rabe (SD-039-0734) [13]	12	BUD/FORM 160/4.5 μg, 1 inhalation twice daily + as needed	BUD/FORM 160/4.5 μg, 1 inhalation twice daily + FORM 4.5 μg as needed or BUD/FORM 160/4.5 μg, 1 inhalation twice daily + terbutaline 0.4 mg as needed	Adults 3040 (90) Adolescents 354 (10)
Kuna (SD-039-0735) [14]	6	BUD/FORM 160/4.5 μg, 1 inhalation twice daily + as needed	BUD/FORM 320/9 μg, 1 inhalation twice daily + terbutaline 0.4 mg as needed or Salmeterol/fluticasone 25/125 μg, 2 inhalations twice daily + terbutaline 0.4 mg as needed	Adults 2712 (81) Adolescents 623 (19)
Bousquet (NCT00242775) [15]	6	BUD/FORM 160/4.5 μg, 2 inhalations twice daily + as needed	Salmeterol/fluticasone 50/500 μg, 1 inhalation twice daily + terbutaline 0.4 mg as needed	Adults 1985 (86) Adolescents 324 (14)

Data are presented as n or n (%), unless otherwise stated. BUD/FORM: budesonide/formoterol; MART: maintenance and reliever therapy. ^#: adults defined as aged ≥18 years; adolescents defined as aged 12–17 years (including four 11-year-olds: n=1 in Rabe et al. [10], n=1 in Scicchitano et al. [11] and n=2 in Kuna et al. [14]); ^¶: children (aged 4–11 years; n=341) were recruited in this study [12], but were not included in the current analysis.