| Methods |
STUDY DESIGN: Parallel group, multicentre, Holland. 12 weeks.
RANDOMISATION: Yes, no method stated.
BLINDING: double blind, double dummy, matching devices.
WITHDRAWALS/DROP OUTS: 45 described after randomization.
COMPLIANCE: Not assessed / reported.
CONFOUNDERS: Groups well balanced by characteristics
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = 301 ENROLLED/ RANDOMISED, ADULT, M = 157 F=144 Mean age: 40 (SD 14)
BASELINE SEVERITY: Stable phase asthma
INCLUSION : Stable phase asthma, Baseline FEV1 <80% predicted, >15% FEV1 reversibility to SABA.
EXCLUSION: Use of theophyllines, oral beta_2 agonists or anticholinergics. |
| Interventions |
LONG ACTING BETA AGONIST: Formoterol 12 mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 200mcg QDS
PLACEBO: placebo BD
DEVICE: MDI
TREATMENT PERIOD: 12 weeks
RESCUE: Salbutamol 100 mcg PRN
CO‐INTERVENTIONS: stable dose ICS, cromones. |
| Outcomes |
OUTCOMES: PEF, Rescue use, asthma attacks.
Efficacy rating |
| Notes |
Asthma attacks not defined. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
