Methods |
Parallel design; duration 8 weeks. Overall, 48/196 patients withdrew from study, but 77/196 were not analysed at 8w. "A double blind design was not used"; not stated if outcome assessor blinded. Concurrent asthma medication: steroids (unspecified), methylxanthines; inhaled bronchodilators withdrawn. |
Participants |
Inclusion criteria: patients had asthma ‐ diagnosis according to ATS criteria and >15% reversibility after beta‐agonist; exclusions: pregnancy, respiratory failure, diabetes, contraindications to study drugs. Patient details: 196 participants (M/F group B 56% M; group S 57% M); age: Group B 45 (mean), Group S 48; moderate asthma ( fairly heterogeneous severity); atopy not stated; no information on concurrent COPD. |
Interventions |
2 interventions: Berodual, Salbutamol 200µg; both interventions q.i.d. (times not stated). |
Outcomes |
PEF (daily) over 7 days (1,2,3,4,5,6,7,8w), symptom scores (not daily), FEV1, PEFR, FVC at 30 and 60 days; adverse effects (but too much data missing); standard deviations. |
Notes |
Many withdrawals and missing patient data, therefore only used week 1 data for PEFR; concealment: numbered boxes, serially allocated. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Low risk |
Investigators blinde to randomisation sequence (Cochrane Grade A) |