| Methods |
Study Design: Parallel RCT
Randomisation: random stated, method not described
Concealment of Allocation:
Double Blinding: Yes. Plain MDI used without spacer for both placebo and salmeterol
Withdrawals / dropouts: described
Adverse events: described
Statistical analysis: described
Jadad Score: 3 |
| Participants |
Study site: multicentre
No eligible: 46
No randomised: 42
No completed: 24 (12/12)
Sex: Males:25%/0%; Females: 75%/100%
Age (mean, range): Intervention1:39.6yrs (30‐57); Intervention 2: 46.6yrs (22‐68)
Diagnostic criteria for asthma: According to criteria of the National Institutes of Health (NIH) International Consensus report
Inclusion criteria: > 18 yrs, on maintenance ICS >= 1000mcg/day
Exclusion criteria: Chronic bronchitis, emphysema, pregnancy, inability to use peak flow meter or pMDI/spacer, clinically significant cardiac disease, psychosis, or substance abuse.
Baseline severity of asthma: PEF (mean,SD): 386 (76)/388 (107); childhood onset asthma: 83%/67%; Rhinitis: 100%/75%; Sinusitis history: 58%/42%; History GERD: 42%/25% |
| Interventions |
Run in phase: 4 weeks usual ICS (BDP, triamcinolone, flunisolide) to assess stability then randomised if stable to either:
1: Salmeterol 100mcg bd , OR
2: Placebo
PLUS usual ICS for two weeks then ICS reduction commenced.
ICS reduction: ICS reduced by at least 10% (but not more than 25%) every 4 weeks if stable (PEF >=80%; FEV1>=80%; and rescue mediation use < 4 x day). ICS was not reduced below 500mcg/day for patients with mod/severe asthma.
Delivery device: pMDI
Duration of treatment: 12 months
Other: ICS optimised (with use of spacer), patient education and crisis prednisolone provided with written instruction on its use (PEF < 50% personal best) at commencement of study. |
| Outcomes |
% ICS dose reduction, FEV1 % predicted, PEF, rescue medications, ER visits, hospitalisations, days off work, adverse event (tremor), QOL. |
| Notes |
Comparison 2: Reduced dose ICS |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Described as randomised; other information not available |
| Allocation concealment? |
Unclear risk |
Information not available |
| Blinding?
All outcomes |
Low risk |
Plain MDI used without spacer for both placebo and salmeterol |
