| Methods |
STUDY DESIGN: Parallel group‐multicentre , 20 Scandinavia.12 weeks.
RANDOMISATION: Yes, no method stated.
BLINDING: double blind, double dummy, matching devices.
WITHDRAWALS/DROP OUTS: 42 described after randomization.
COMPLIANCE:. Not assessed
CONFOUNDERS: Groups well balanced by characteristics
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = 362 ENROLLED, 304 RANDOMISED. ADULT , M = 60 F = 47 Mean age: 48 (SD 13)
BASELINE SEVERITY: not specified, clinically stable.
INCLUSION : Baseline FEV1 > 40% predicted, > 15% FEV1 reversibility to SABA. Requiring SABA.
EXCLUSION: unstable asthma, altered dose medication. |
| Interventions |
LONG ACTING BETA AGONIST: Formoterol 12 mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 400 mcg QDS
PLACEBO: placebo QDS
DEVICE: Dry powder device.
TREATMENT PERIOD: 12 weeks
RESCUE: Salbutamol 100 mcg PRN
CO‐INTERVENTIONS: ICS 84%, OS 6%, cromones stable dose |
| Outcomes |
OUTCOMES: FEV1, FVC, PEF, Rescue use, asthma symptom score. adverse events, including asthma exacerbations.
Efficacy rating |
| Notes |
Symptom Score‐ Day: 0 = none, to 3 = very severe symptoms. Night: 0 = none to 3 = almost no sleep due to asthma. No definition of asthma exacerbation recorded as an adverse event given. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
