| Methods |
STUDY DESIGN: Parallel group, multicentre, 20 centres UK, Norway, Denmark. 6 wks.
RANDOMISATION: Yes, no method stated.
BLINDING: double blind, double dummy, matching devices.
WITHDRAWALS/DROP OUTS: 17 described.
COMPLIANCE: Not assessed/ reported.
CONFOUNDERS: Groups well balanced by characteristics.
QUALITY: Jadad 4. Cochrane B |
| Participants |
N = 286 RECRUITED, 190 ENROLLED. Adults, M = 100 F=90 Mean age 51 (RANGE 18‐80)
BASELINE SEVERITY: moderate to severe symptomatic asthma.
INCLUSION : Baseline FEV1 30‐75% predicted, >15% FEV1 reversibility to SABA. Symptoms on 4/7 days run in, using > 1200mcg BUD or 1500mcg BDP
EXCLUSION: URTI/ Change in asthma medication/ exacerbation asthma within 2 wks. Maintenance with OS. |
| Interventions |
LONG ACTING BETA AGONIST: Salmeterol 100 mcg BD
SHORT ACTING BETA AGONIST: Salbutamol 400mcg QDS
PLACEBO: Placebo BD
DEVICE: Dry powder device‐ DISKHALER
TREATMENT PERIOD: 6 weeks
RESCUE: Salbutamol 200 mcg PRN
CO‐INTERVENTIONS: ALL ON ICS . theophyline 18% Ipratroprium 10% |
| Outcomes |
OUTCOMES: FEV1, FVC, FEV 25 to 75%, PEF, Rescue use, asthma symptom score, symptom free days & nights, adverse events .
Efficacy rating |
| Notes |
Symptom Score‐ Night‐time 0 to 3 (none ‐ so severe that no sleep possible). Day‐time 0‐4 (no symptoms ‐ symptoms so severe normal activities not possible). Exacerbations asthma defined as worsening of asthma requiring a change in therapy . |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
