| Methods |
Study Design: Parallel RCT
Randomisation: computer generated random numbers
Concealment of Allocation: coded identical inhalers
Double Blinding: Yes
Withdrawals / dropouts: Described
Adverse events: Described
Statistical analysis: Intention to treat
Jadad Score: 5 |
| Participants |
Study site: Multi‐centred pulmonary/allergy clinics
No eligible:
No randomised: Interventions 1&2: 454 (231;223); Intervention 3: 226 (N/A)
No completed: Interventions 1&2: 425 (215;210); Intervention 3: 205 (N/A)
Sex: Males ‐ Intervention 1: 95 (45%); Intervention 2: 86 (39%); Intervention 3: N/A
Age (mean, range): 1: 41 (12‐79); 2: 40 (12‐74); 3: N/A
Diagnostic criteria for asthma: ATS criteria
Inclusion criteria: >= 12 yrs, FEV1 40‐85% predicted, >= 15% bronchodilator reversibility, nonsmokers, requiring maintenance ICS for 3 months prior to study
Exclusion criteria: pregnancy, lactation, use of methotrexate, gold, cyclosporine, or azathioprine, inhaled cromolyn, nedocromil, oral or injectable steroids in past month. Significant comorbidity, other prescription medication.
Baseline severity of asthma: FEV1 (mean, SE): 1: 2.14 (0.04); 2: 2.12 (0.04), FEV1 % (mean, SE): 1: 63.1(0.78); 2: 63.1 (0.82), PEF % (mean, SE): 1: 68 (1); 2: 65 (1) |
| Interventions |
Run in phase: 2 weeks on usual ICS, If FEV1 40‐65% predicted or 65.1%‐85% and symptomatic at end of run‐in they were eligible for randomisation.
1: FP 100mcg BID (200mcg/day, ex‐valve) & salmeterol 50mcg BID (100mcg/day, ex‐valve)
2: FP 250mcg BID (FP 500mcg/day, ex‐valve)
3: Triamcinalone 600mcg BID (1200mcg/day) ‐ Not applicable for this review
Delivery device: MDI plus spacer
Duration of treatment: 12 weeks
Other: Albuterol allowed prn and theophylline at fixed dose if part of usual treatment regimen. Albuterol and theophylline were withheld >= 6 hours prior to study visits. |
| Outcomes |
Adverse events, withdrawal due to adverse events,overall withdrawals, physician global assessment.
Measured as change from baseline: Morning & evening PEF (L/min), PEF % predicted, morning & evening FEV1 (L), FEV1 % predicted, rescue medications (puffs/day), % rescue free days, night awakenings, asthma symptom score, % symptom free days. 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? |
Low risk |
Computer generated random numbers |
| Allocation concealment? |
Low risk |
Investigators unaware as to order of randomisation |
| Blinding?
All outcomes |
Low risk |
Identical inhaler devices used |
