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12 participants were withdrawn from the study.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 |