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. 2007 Jul 18;2007(3):CD001281. doi: 10.1002/14651858.CD001281.pub2

Malolepszy 2002.

Methods Multicentre randomised controlled trial (method of randomisation not described) double blind, parallel study.
Participants Of 93 eligible, 81 participants with ages ranging from 18 to 60 were randomised. Demographic data : values presented as mean (SD) or as appropriate: 
 Formoterol group: 
 number : 41 
 gender : M:F‐ 16:25 
 median age (years) ‐ 41.3 with a range of 18.3 to 60.9. 
 Baseline FEV1(litres)‐ 2.15. 
 Baseline FVC(litres)‐3.03. 
 Baseline PEF(l/sec):4.79. 
 Baseline serum ECP(mcg/l) ‐ 13.78. 
 Theophylline group : 
 number : 40. 
 gender (M:F): 14:26. 
 Median age (years): 44.5 with a range of 22.9 to 60.9. 
 Baseline FEV1(litres) ‐ 2.10. 
 Baseline FVC (litres) ‐ 2.88. 
 Baseline PEF(I/sec) ‐ 4.84. 
 Baseline serum ECP(mcg/l) : 12.66.
Interventions Formoterol 12 mcg BD (MDI) versus oral slow release theophylline 250 or 350 mg twice daily for 12 weeks.
Outcomes FEV1, change in serum eosinophil cationic protein, asthma scores, rescue medication use and adverse events.
Notes This study was published in German. Method of randomisation not stated. All participants in this study were on inhaled corticosteroids. 
 12 participants were withdrawn from the study. The results in this study ‐ FEV1, FVC, PEF and ECP are reported as mean and range.
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Information not available
Allocation concealment? Unclear risk Information not available