| Methods |
STUDY DESIGN: Parallel group, conducted as 2 separate studies, multicentre 91 in 17 countries.
RANDOMISATION: Yes, no method stated.
BLINDING: double blind, matching devices.
WITHDRAWALS/DROP OUTS: 50 described after randomization.
COMPLIANCE: Not assessed.
CONFOUNDERS:
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = ENROLLED, 847 RANDOMISED. Children , M = 534 F = 313 Mean age: 10.2 (SD 2.9)
BASELINE SEVERITY: Symptommatic asthma requiring inhaled SABA therapy.
INCLUSION : > 15% FEV1/PEF reversibility to SABA. Symptoms on 5/7 days run in, requiring SABA 7/14 days.
EXCLUSION: Exacerbation asthma requiring hospital/ LRTI within 1 mth, current OS. |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 25 mcg BD or Salmeterol 50 mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 200 mcg BD
PLACEBO: none
DEVICE: MDI or Diskhaler.
TREATMENT PERIOD: 52 weeks
RESCUE: Salbutamol 100 mcg PRN
CO‐INTERVENTIONS: ICS > 60%, cromones 23% |
| Outcomes |
OUTCOMES: FEV1, FVC, PEF, Rescue use, asthma symptom free days & nights, exacerbations, adverse events. |
| Notes |
Exacerbations defined as worsening of asthma symptoms that required treatment in addition to the study drug and rescue SABA.
Symptom Score‐ Night‐time 0 to 3 (none ‐ so severe that no sleep possible). Day‐time 0 to 3 (no symptoms ‐ symptoms so severe normal activities not possible) |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
