| Methods |
STUDY DESIGN: Parallel group‐single centre , Holland. 6 weeks.
RANDOMISATION: Yes, no method stated.
BLINDING: double blind, matching devices.
WITHDRAWALS/DROP OUTS: 13 described after randomization.
COMPLIANCE:. Not assessed
CONFOUNDERS: Groups well balanced by characteristics. Not ITT
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = ENROLLED, 120 RANDOMISED. 107 COMPLETED ADULT , M = 60 F = 47 Mean age: 53 (SD 14)
BASELINE SEVERITY: Moderate asthma
INCLUSION : Baseline FEV1 50 to 70% predicted, > 15% FEV1 reversibility to SABA.
EXCLUSION: URTI/ LRTI < 6 WKS. OS, theophyllines, uncontrolled illness. |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 50 mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 400 mcg BD
PLACEBO:
DEVICE: Dry powder device‐ diskhaler.
TREATMENT PERIOD: 6 weeks
RESCUE: Salbutamol 400 mcg PRN
CO‐INTERVENTIONS: ICS 31%, cromones stable dose |
| Outcomes |
OUTCOMES: FEV1, FVC, PEF, Rescue use, asthma symptom score, efficacy score, AQOL/LWAQ scores, % days with no symptoms ,% nights with no asthma awakenings .
Eficacy rating |
| 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) |
