Table 2.
Individual study designs for treatment of asthma
| Reference | Country | No of patients | Run in (weeks) | Duration (weeks) | Definition of ITT* | Inhaled steroid | Baseline dose (μg/day) | Comparison dose (μg/day) |
|---|---|---|---|---|---|---|---|---|
| Greening2 | UK | 426 | 2 | 26 | 1† | BDP | 400 | 1000 |
| Ind7 8 | Europe, Canada | 336 | 4 | 24 | 1 | Fluticasone | 500 | 1000 |
| Woolcock9 | Worldwide | 494 | 1-5 | 24 | 1 | BDP | 1000 | 2000 |
| Kelsen10 | US | 483 | 2 | 24 | 2 | BDP | 400 (336)‡ | 800 (672) |
| Murray11 | US | 514 | 2 | 24 | 2 | BDP | 400 (336)‡ | 800 (672) |
| Kalberg12 | US | 488 | 2-4 | 24 | 2 | Fluticasone | 200 (176)‡ | 500 (440) |
| Condemi13 | US | 437 | 2-4 | 24 | 2 | Fluticasone | 200 (176)‡ | 500 (440) |
| Van Noord14 | Holland | 60 | 4 | 12 | 1 | Fluticasone | 200 (LD) | 400 (LD) |
| Van Noord14 | Holland | 214 | 4 | 12 | 1 | Fluticasone | 500 (HD) | 1000 (HD) |
| Vermetten15 | Holland | 233 | 2 | 12 | 1 | BDP | 200-400 | 800 |
BDP=beclometasone dipropionate.
*
1—all patients randomised to treatment; 2—all patients randomised to treatment who took at least a single dose of study medication.
†
430 patients were randomised, but data for four patients were reported as “unverifiable” and so these patients were not included in ITT population.
‡
UK equivalent dose (dose leaving valve), with US dose (dose leaving mouthpiece) in parentheses.