| Methods |
STUDY DESIGN: 2 period cross over, general practice setting, 29 GPs , Denmark. 4 week treatment period.
RANDOMISATION: Yes, no method stated.
BLINDING: double blind, double dummy, matching devices.
WITHDRAWALS/DROP OUTS: 36 pre‐randomisation, 10 described after randomization.
COMPLIANCE:. Not assessed / reported.
CONFOUNDERS: Groups well balanced by characteristics
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = 128 ENROLLED/ 92 RANDOMISED, ADULT, M = 36 F=56 Mean age: 40
BASELINE SEVERITY: Mild‐moderate stable asthma
INCLUSION : Stable phase asthma, run‐in PEF average >50% predicted, >15% PEF reversibility to SABA.
EXCLUSION: uncontrolled disease, pregnancy, Use of theophyllines, oral beta_2 agonists or anticholinergics. |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 50 mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 400mcg QDS
PLACEBO: placebo BD
DEVICE: Diskhaler
TREATMENT PERIOD: 4 weeks
RESCUE: Salbutamol 400 mcg PRN
CO‐INTERVENTIONS: none 28%, ICS 72%, OS, cromones. |
| Outcomes |
OUTCOMES: PEF, Rescue use, asthma symptom score, adverse events. |
| Notes |
Symptom Score‐ Night‐time 0 to 4 (none ‐ so severe that no sleep possible). Day‐time 0 to 5 (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) |
