| Methods |
STUDY DESIGN: 3 way cross over, 2 centre, New Zealand. 24 weeks.
RANDOMISATION: Yes, no method stated.
BLINDING: double blind, double dummy, matching devices.
WITHDRAWALS/DROP OUTS: 35 described after randomization and 8 protocol violators.
COMPLIANCE:. Assessed by counting blisters, > 87%
CONFOUNDERS: Not analysed by ITT, Efficacy analysis similar.
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = ENROLLED, 165 RANDOMISED, 157 ANALYSED. ADULT , M = 73 F = 92 Mean age: 38 (range 18 to 64)
BASELINE SEVERITY: Mild‐moderate asthma
INCLUSION : > 15% FEV1 reversibility to SABA. PC20 methacholine < 8mg/ml.
EXCLUSION: current smokers, requiring OS or theophyllines, SABA requirement > 10 puffs/day, significant illness. |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 50 mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 400 mcg QDS
PLACEBO: placebo QDS
DEVICE: Dry powder device‐ diskhaler.
TREATMENT PERIOD: 24 weeks
RESCUE: Salbutamol 100 mcg PRN
CO‐INTERVENTIONS: None 8%, ICS 92%, cromones stable dose |
| Outcomes |
OUTCOMES: FEV1, FVC, PEF, Rescue use, exacerbations, daily asthma score. |
| Notes |
Exacerbations‐ Major = daily asthma score 3, PEF 40 to 60% predicted, requiring OS.
Minor‐ Daily asthma score 2, PEF 61 to 75% predicted, increased rescue use. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
