Table. Studies and Treatment Steps Included in the Systematic Review and Meta-analysis.
| Trial | Trial type | GINA step at enrollment | Treatmenta | Total daily maintenance dose of ICS, μg (dose level according to GINA 2018) [GINA step] | Patients per group included in this study, No. | Patients randomized to SMART and control groups in the trials, No. |
|---|---|---|---|---|---|---|
| SMART vs step up in GINA step maintenance ICS-LABA treatment with SABA reliever | ||||||
| AHEAD10 | Randomized, double-blind, parallel-group | Step 3 | SMART: BUD-FORM, 160/4.5 μg, 2 times twice daily and as needed | 640 (Medium) (step 4) | 371 | 1154 |
| Control: FLU-SAL, 500/50 μg, 1 time twice daily and as-needed TERB, 0.4 mg | 1000 (High) [step 4] | 373 | 1155 | |||
| COMPASS8 | Randomized, double-blind, double-dummy, parallel-group | Step 3 | SMART: BUD-FORM, 160/4.5 μg, 1 time twice daily and as needed | 320 (Low) [step 3] | 372 | 1107 |
| Control: FLU-SAL, 125/25 μg, 2 times twice daily and as-needed TERB, 0.4 mg | 500 (Medium) [step 4] | 377 | 1123 | |||
| Control: BUD-FORM, 320/9 μg, 1 time twice daily and as-needed TERB, 0.4 mg | 640 (Medium) [step 4] | 397 | 1105 | |||
| Patel et al9 | Randomized, open-label, parallel-group | Step 3 | SMART: BUD-FORM, 200/6 μg, 2 times twice daily and as needed | 800 (Medium) [step 4] | 38 | 151 |
| Control: BUD-FORM, 200/6 μg, 2 times twice daily and as-needed SALB, 100 μg | 800 (Medium) [step 4] | 22 | 152 | |||
| SMART vs continuation in GINA step maintenance ICS-LABA treatment with SABA reliever | ||||||
| AHEAD10 | Randomized, double-blind, parallel-group | Step 4 | SMART: BUD-FORM, 160/4.5 μg, 2 times twice daily and as needed | 640 (Medium) [step 4] | 327 | 1154 |
| Control: FLU-SAL, 500/50 μg, 1 time twice daily and as-needed TERB, 0.4 mg | 1000 (High) [step 4] | 348 | 1155 | |||
| COMPASS8 | Randomized, double-blind, double-dummy, parallel-group | Step 4 | SMART: BUD-FORM, 160/4.5 μg, 1 time twice daily and as needed | 320 (Low) [step 3] | 333 | 1107 |
| Control: FLU-SAL, 125/25 μg, 2 times twice daily and as-needed TERB, 0.4 mg | 500 (Medium) [step 4] | 335 | 1123 | |||
| Control: BUD-FORM, 320/9 μg, 1 time twice daily and as-needed TERB, 0.4 mg | 640 (Medium) [step 4] | 346 | 1105 | |||
| Patel et al9 | Randomized, open-label, parallel-group | Step 4 | SMART: BUD-FORM, 200/6 μg, 2 times twice daily and as needed | 800 (Medium) [step 4] | 46 | 151 |
| Control: BUD-FORM, 200/6 μg, 2 times twice daily and as-needed SALB, 100 μg | 800 (Medium) [step 4] | 48 | 152 | |||
| SAKURA12 | Randomized, double-blind, parallel-group | Step 3 | SMART: BUD-FORM, 160/4.5 μg, 1 time twice daily and as needed | 320 (Low) [step 3] | 251 | 1049 |
| Control: BUD-FORM, 160/4.5 μg, 1 time twice daily and as-needed TERB, 0.4 mg | 320 (Low) [step 3] | 215 | 1042 | |||
| SMILE11 | Randomized, double-blind, parallel-group | Step 3 | SMART: BUD-FORM, 160/4.5 μg, 1 time twice daily and as needed | 320 (Low) [step 3] | 339 | 1113 |
| Control: BUD-FORM, 160/4.5 μg, 1 time twice daily and as-needed TERB, 0.4 mg | 320 (Low) [step 3] | 325 | 1141 |
Abbreviations: BUD-FORM, budesonide-formoterol; FLU-SAL, fluticasone-salmeterol; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroid; SABA, short-acting β2-agonist; SALB, salbutamol; SMART, single maintenance and reliever therapy; TERB, terbutaline.
a
In the study by Patel et al,9 BUD-FORM is expressed as metered doses. In all other studies, it is given as delivered doses.