| Methods |
STUDY DESIGN: Parallel group, single centre, Brazil, 4 wks.
RANDOMISATION: Yes, method not stated.
BLINDING: double blind, double dummy.
WITHDRAWALS/DROP OUTS: 7 described after randomization.
COMPLIANCE: No details
CONFOUNDERS: Groups well balanced by characteristics
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = 136 ENROLLED/ 60 RANDOMISED/53 COMPLETED, ADULT , M=17 F=43 Mean age: 37 (range 18‐64)
BASELINE SEVERITY: Mild‐moderate symptomatic asthma
INCLUSION : Diagnosis asthma by ATS criteria, Baseline FEV1 >50% predicted, >15% FEV1 reversibility to SABA.
EXCLUSION: Use of theophyllines or anticholinergic, except in acute attack. |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 50 mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 200 mcg QDS
PLACEBO: placebo BD
DEVICE: MDI.
TREATMENT PERIOD: 4 weeks
RESCUE: Salbutamol 100 mcg PRN
CO‐INTERVENTIONS: ICS > 42%, |
| Outcomes |
OUTCOMES: FEV1, FVC, PEF, Rescue use, asthma symptom score, adverse events, |
| Notes |
Symptom Score‐ Night‐time 0‐4 (none ‐ so severe that no sleep possible). Day‐time 0‐4 (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) |
