| Methods |
RCT: parallel group design.
Blinding: none. |
| Participants |
ICS: 35 at entry, 34 at completion (97% completed).
SCG: 29 at entry, 26 at completion (90% completed).
Mean age: 10.2
Age range: 6‐16.
Gender: 67% male.
Race/ethnicity: not reported
Setting: 10 out‐patient clinics and 9 general practices around the UK.
Asthma severity: mild to moderate persistent (based on average FEV1).
Inclusion: 1) age 6‐16 yrs; 2) history of asthma and documented response to b‐agonist; 2) currently receiving b‐agonist and DSCG but still experiencing symptoms; 3) competent with peak‐flow meter.
Exclusion: 1) glucocorticosteroids by any route within previous month. |
| Interventions |
After a 4 wk run‐in period on usual dose of DSCG, patients were randomized to 8 weeks of budesonide or DSCG. After first four weeks of treatment, dosage was maintained or halved at discretion of doctor. Patients were allowed to use inhaled b2‐agonist for symptomatic relief. Other asthma medications (eg oral bronchodilators) were permitted at a constant dose.
Duration: 8 weeks
Dose: 400 mcg (ICS); 40 mg
(SCG). Dose could be reduced to 200 mcg (ICS) or 20 mg (SCG) after first 4 weeks at discretion of investigator.
Doses/day: 2
(ICS) ; 4 (SCG); Daily dose 800 mcg (ICS) Medium dose; 160 mg(SCG)
Cumulative dose: 44800 mg
(ICS); 8960 mg
(SCG). If dosage is not reduced after 4 weeks.
Delivery device: DPI. |
| Outcomes |
FEV1, diary card am/pm PEF, clinic visit am/pm PEF, "overall" asthma severity, b2‐agonist use,
withdrawals, sore throat. |
| Notes |
Jadad Quality
Score: 2
Possible selection bias (differences in baseline characteristics). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
