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Table 1 Description of studies

From: Withdrawal of inhaled corticosteroids in individuals with COPD - a systematic review and comment on trial methodology

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     Duration Treatment Steroid group Withdrawn group  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'Brien 17 /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
COPE 15 /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
COSMIC 16 /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
  1. *Primary outcome measures.