| Methods |
STUDY DESIGN: 3 way cross over, multicentre, 14 centres Canada, 4 wks.
RANDOMISATION: Yes, no method stated.
BLINDING: Double blind, double dummy, matching inhalers.
WITHDRAWALS/DROP OUTS: 21 described after randomization.
COMPLIANCE: >70% reported for all but 7 subjects.
CONFOUNDERS:
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = 140 RANDOMISED. Adults, M = 66 F = 74 Mean age 37.5 (sd 14.5)
BASELINE SEVERITY: mild to moderate asthma.
INCLUSION : Baseline FEV1 > 60% predicted, > 15% FEV1 reversibility to SABA. Symptom score > 2 on 4/7 days run in
EXCLUSION: Exacerbation asthma within 1 mth, emergency room visit > 3 mths, uncontrolled illness, pregnancy. OS within 1mth. Theophylline . |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 50 mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 200 mcg QDS
PLACEBO: placebo QDS
DEVICE: MDI.
TREATMENT PERIOD: 4 weeks
RESCUE: Salbutamol 100 mcg PRN
CO‐INTERVENTIONS: ICS 77%. Cromones 15%, 30% none. |
| Outcomes |
OUTCOMES: FEV1, FVC, FEV 25‐75%, PEF, Rescue use, asthma symptom score, symptom free days & nights, adverse events, AQOL scores. |
| Notes |
AQOL score measures‐symptoms, emotions, activity limitation, environment‐overall scores + individual domains |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
