Study | No. of patients | Duration of study (weeks) | Dose of fluticasone (µg/day) | Device | Range (mean) of FEV1 as % of predicted | Age (mean) | Baseline ICS usage* | Outcome measures | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
FEV1 | Morning PEF | Evening PEF | β-agonist use | Exacerbations | Night awakenings | Symptom score | ||||||||
FEV1, forced expiratory volume in one second; PEF, peak expiratory flow; MDI, metered dose inhaler. | ||||||||||||||
*BDP or equivalent μg/day. | ||||||||||||||
Placebo controlled | ||||||||||||||
15 | 437 | 12 | Placebo 100 200 | Diskus Diskhaler | 50–85 (73) | 6–11 | ⩾0 | √ | √ | √ | √ | √ | √ | √ |
17 | 263 | 12 | Placebo 100 200 | MDI | PEF 75–90 | 4–11 (8) | None for 3/12 | √ | √ | √ | √ | √ | √ | √ |
14 | 158 | 12 | Placebo 200 | Diskus | 50–85 (70) | 6–11 (8.5) | ⩾0 | √ | √ | √ | √ | √ | √ | √ |
18 | 258 | 4 | Placebo 100 | MDI | (80) | 6–14 (9) | None for 6/12 | √ | √ | √ | √ | √ | X | √ |
16 | 34 | 12 | Placebo 200 | Diskhaler | >75 (90) | 8–14 (10.5) | None for 1/12 | √ | √ | √ | √ | √ | X | √ |
Non-placebo controlled | ||||||||||||||
21 | 55 | 52 | 200 1000 step down to 100 | Diskhaler | (91) | 6–10 | <800 | √ | √ | √ | X | √ | X | √ |
20 | 528 | 52 | 200 400 | Diskus | PEF 103 | 4–11 (8) | 800–1600 or ⩽5 mg/day prednisone | X | √ | √ | √ | √ | X | √ |