Table 1.
Description of studies
| Trial/Country/Publication date | Type of study | Duration & follow-up | Number of patients randomised | Run-in period | Trial period medication | Outcomes | ||
|---|---|---|---|---|---|---|---|---|
| Duration | Treatment | Steroid group | Withdrawn group | |||||
| WISP14/United Kingdom/2007 | Parallel | 12 months (follow up every 3 months) | 260 | 2 weeks | Patient's usual medication | FP 500 ug twice daily | Placebo | Exacerbation frequency* Time to first exacerbations Respiratory symptoms PEFR Reliever inhaler use Lung function HRQL |
| O'Brien17/USA/2001 | Crossover | 12 weeks (follow up every 3 weeks) | 24 | None | n/a | BDP 84 ug 4 times daily | Placebo | Lung function* Exercise capacity* HRQL Sputum analysis |
| COPE15/Netherlands/2002 | Parallel | 6 months (follow up at 3& 6 months) | 244 | 4 months | FP 500 ug twice daily & ipratropium bromide 40 ug four times daily | FP 500 ug twice daily and Ipratropium | Placebo and Ipratropium | First and second exacerbations* Rapid recurrent exacerbation* HRQL* Lung function Exercise tolerance Use of healthcare facilities Respiratory symptoms |
| COSMIC16/Netherlands/2005 | Parallel | 12 months (follow up at weeks 0, 4, 11, 12, 16, 28, 40, 52, 64 & 66) | 373 | 3 months | Combined salmeterol 50 ug & fluticasone 500 ug twice daily | Combined salmeterol 50 ug & fluticasone 500 ug twice daily | Salmeterol 50 ug twice daily | Lung function* Exacerbation & use of rescue medication Respiratory symptoms HRQL |
*Primary outcome measures.