| Methods |
Study Design: Parallel RCT
Randomisation: computer generated randomisation code in block sizes of 4.
Concealment of Allocation: not stated
Double Blinding: Yes
Withdrawals / dropouts: Described
Adverse events: described
Statistical analysis: described ‐ per protocol analysis
Jadad Score: 4 |
| Participants |
Study site: 146 General Practices
No eligible: 855
No randomised: 682 (343/338) ‐one subject withdrew before commencement of treatment.
No completed: 454 (223/231) 18 weeks. 295 (146/149) 24 weeks
Sex: Males 297 (43.6%); Females 384 (56.4%)
Age: mean (SD) Intervention1: 33.5(13.8), Intervention 2: 33.3 (15.6)
Diagnostic criteria for asthma: 'documented diagnosis of asthma.'
Inclusion criteria: > 12 years, asthma symptoms 2 out of the past 7 days, bronchodilator prn for last 2 weeks, requiring ICS according to Dr.
Exclusion criteria: PEF <60% predicted, pregnancy, breast feeding, significant concomitant disease, medication in last 3 months of beta 2 blockers, sodium cromoglycate or sodium nedocromil.
Baseline severity of asthma: PEF mean (SD) ‐ Intervention1: 418(92), Intervention 2: 408 (89) |
| Interventions |
1: Budesonide 800mcg /day (400mcg bd) for 6 weeks; Budesonide 400mg nocte for another 12 weeks; if met asthma controlled criteria budesonide 200mcg nocte for a further 6 weeks.
2: Budesonide 400mcg nocte/ placebo mane for 6 weeks; budesonide 400mcg nocte for further 12 weeks; if asthma controlled then budesonide 200mcg nocte for 6 weeks.
Delivery device: DPI
Duration of treatment: Initial treatment 6 weeks, 12 weeks phase 2 ‐ static dose for lntervention2 and step down for Intervention1; then for those subjects who achieved asthma control a further reduction to 200mcg for 6 weeks. Total duration 24 weeks.
Run in phase: 4‐10 days
Other: |
| Outcomes |
PEF, rescue medication, nocturnal asthma, asthma symptoms (diary and clinic), adverse events, compliance, asthma control at 18 weeks |
| Notes |
High dropout rate ‐ 50% non compliance.
For morning PEF and day rescue medications it was assumed that the variance was SE as the measure was very small in comparison to the reported clinic PEF SD and night rescue meds SD mentioned in the text. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer generated randomisation code in block sizes of 4. |
