Methods | Parallel-group study Jadad quality score: 1 |
|
Participants | Symptomatic asthmatic children % ELIGIBLE OF SCREENED POPULATION: Not reported % RUN-IN PARTICIPANTS RANDOMISED: Not reported RANDOMISED: 20 (BDP/Sal: 10; BDP: 10) WITHDRAWALS: Not described AGE range: 6 to 19 years GENDER (% male): Not described SEVERITY: Moderate BASELINE % PREDICTED FEV1: Not described ASTHMA DURATION: Not reported ATOPY(%): Not reported ELIGIBILITY CRITERIA: Still symptomatic despite maintenance treatment with 200 mcg bid of BDP EXCLUSION CRITERIA: Not described |
|
Interventions | LABA + ICS vs INCREASED dose ICS OUTCOMES: reported at 8,12 weeks RUN-IN PERIOD: 2 weeks DOSE OF ICS DURING RUN-IN: BDP 200 bid DOSE OPTIMISATION PERIOD: None INTERVENTION PERIOD: 12 weeks TEST GROUP: Salmeterol 50 mcg bid + beclomethasone 200 mcg bid CONTROL GROUP: Beclomethasone 400 bid DEVICE: Not specified NUMBER OF DEVICES: 2 COMPLIANCE: Not reported CO-TREATMENT: Not specified |
|
Outcomes | PULMONARY FUNCTION TEST: FEV1; PEF; FEF 25% to 75% SYMPTOM SCORES: Daily symptoms (no data for control group) FUNCTIONAL STATUS: Not reported INFLAMMATORY MARKERS: Not reported ADVERSE EFFECTS: Not reported WITHDRAWAL: Not reported |
|
Notes | Abstract Funding not reported Confirmation of methodology and data extraction: Not obtained User-defined order: 400 |
|
Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Unclear | Described as randomised; no other information presented |
Allocation concealment? | Unclear | Information not available |
Blinding? All outcomes |
No | Open label |
Incomplete outcome data addressed? All outcomes |
Unclear | No information provided |
Free of selective reporting? | Unclear | Unclear whether data on OCS-treated exacerbations were collected in the study |