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. 2011 Aug 12;12(1):107. doi: 10.1186/1465-9921-12-107

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Duration Treatment Steroid group Withdrawn group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.