| Methods |
STUDY DESIGN: Parallel group, multicentre, 23 centres Europe. 4 wks.
RANDOMISATION: Yes, no method stated.
BLINDING: open label, not blinded.
WITHDRAWALS/DROP OUTS: 15 after randomization.
COMPLIANCE: 93 ‐ 96% reported.
CONFOUNDERS: Groups well balanced by characteristics.
QUALITY: Jadad 2. Cochrane B |
| Participants |
N = 243 RANDOMISED. Adults, M = 120 F = 123 Mean age 48 (RANGE 18 to 78)
BASELINE SEVERITY: mild to moderate asthma.
INCLUSION : Baseline FEV1 > 75% predicted, > 15% FEV1 reversibility to SABA. Symptom score >2 on 4/7 days run in
EXCLUSION: LRTI/ exacerbation asthma within 1 mth. OS > 20mg/day |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 50 mcg BD
SHORT ACTING BETA AGONIST: Terbutaline 500mcg QDS
PLACEBO: none
DEVICE: Dry powder devices‐ diskhaler, turbuhaler.
TREATMENT PERIOD: 4 weeks
RESCUE:Salbutamol 400 mcg PRN
CO‐INTERVENTIOS: ICS 73% . OS 3% Cromones, |
| Outcomes |
OUTCOMES: FEV1, FVC, PEF, Rescue use, asthma symptom score, adverse events .
Efficacy rating |
| Notes |
Symptom Score‐ Night‐time 0 to 4 (none ‐ so severe that no sleep possible). Day‐time 0 to 5 (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) |