| Methods |
STUDY DESIGN: Parallel group‐ multicentre 47 in 11 countries. 12 weeks.
RANDOMISATION: Yes, no method stated.
BLINDING: double blind, double dummy, matching devices.
WITHDRAWALS/DROP OUTS: 85 described after randomization.
COMPLIANCE:. Not assessed
CONFOUNDERS: Groups well balanced by characteristics
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = 460 ENROLLED, 388 RANDOMISED. ADULT , M = 187 F = 201 Median age: 44 (range 19 to 79)
BASELINE SEVERITY: Mild to moderate asthma
INCLUSION : Baseline FEV1 > 50% predicted, > 15% FEV1 reversibility to SABA. Symptoms on 4/7 days run in.
EXCLUSION: OS 20mg/day, uncontrolled illness. |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 50 mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 200 mcg QDS
PLACEBO: Placebo BD
DEVICE: Dry powder device‐ diskhaler.
TREATMENT PERIOD: 12 weeks
RESCUE: Salbutamol 200 mcg PRN
CO‐INTERVENTIONS: ICS 55%, os 10%. cromones stable dose |
| Outcomes |
OUTCOMES: FEV1, FVC, PEF, Rescue use, asthma symptom score, adverse events .
exacerbations |
| Notes |
Exacerbations defined as worsening of asthma symptoms that required treatment in addition to the study drug and rescue SABA. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
