| Methods |
Study Design: Parallel RCT
Randomisation: random stated, method not described.
Concealment of Allocation: not stated.
Double Blinding: Yes.
Withdrawals / dropouts: described.
Adverse events: described.
Statistical analysis: Intention to Treat
Jadad Score: 3 |
| Participants |
Study site: multicentre
No eligible: 760
No randomised: 558 (281/277)
No completed: 235/223 at 12 weeks
Sex: Males 42%; Females 58%
Age (mean,range): Intervention1: 38 (12‐77); Intervention 2: 39 (12‐72).
Diagnostic criteria for asthma: objective lung function.
Inclusion criteria: asthma > 6 months and treated with medium dose ICS for at least 30 days prior to study entry, FEV1 65‐95% predicted, >12% reversibility.
Exclusion criteria: No OCS or parenteral corticosteroids past 30 days, pregnancy or lactation, life‐threatening asthma, asthma hospitalisation in past 3 months, change in asthma maintenance in past 30 days, significant concurrent disease including upper or lower respiratory tract infection.
Baseline severity of asthma (mean, SD): 80.5 (9.7)/80.9 (9.4)% predicted |
| Interventions |
Run in 1: FP 220mcg bid for 10‐14 days. If stable continue to
Run in 2: FP 100 bid for 5‐28 days then if unstable continue to
Run in 3: FP 250mccg bid for 4 weeks to regain asthma control, once controlled ‐randomised to;
Intervention 1: Fluticasone/salmeterol 100/50 mcg bid (200/100mcg/day)
Intervention 2: Fluticasone 250 mcg bid (500mcg/day)
Delivery device: DPI, single device
Duration of treatment: 12 weeks with a proportion randomised to 24 weeks.
Other: No theophylline, other bronchodilators, anticholinergics, leukotriene modifiers, cromolyn, nedocromil, salmeterol or formoterol throughout study. |
| Outcomes |
Withdrawal due to worsening asthma, adverse events, overall withdrawals.
Measured as change from baseline:FEV1(L), morning and evening PEF (L/min), rescue medication use (puffs/day), % rescue medication free days, % symptom free days, daily asthma symptom score, night‐time waking. SDs were calculated based on an ITT analysis |
| Notes |
Comparison 1: Constant dose ICS |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Described as randomised; no other information available |
| Allocation concealment? |
Unclear risk |
Information not available |
| Blinding?
All outcomes |
Unclear risk |
Information not available |
