| 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:Described
Jadad Score: 3 |
| Participants |
Study site: Multicentred
No eligible: Not stated.
No randomised: 307 (79/79/76/73)
No completed: 294(52/48/47/29)
Sex: Male 185 (60%); Female 122(40%).
Age: Mean (range) Intervention 1:28(12‐72); Intervention 2: 30 (12‐63); Intervention 3:30 (12‐69); Intervention 4 :30 (13‐54)
Diagnostic criteria for asthma:Objective lung function
Inclusion criteria:
> 12 yrs, history of asthma requiring daily pharmacotherapy for at least 3 months, FEV1 45‐75% predicted, >= FEV1 reversibility.
Exclusion criteria: Pregnancy or lactating women, patients who had taken long term OCS, Steroids in any form in past month, cromolyn sodium in month prior to study, history of life threatening asthma.
Baseline severity of asthma: FEV1 mean (SEM): Intervention 1: 2.45 (0.06); Intervention 2: 2.38 (0.07); Intervention 3: 2.43 (0.06); Intervention 4: 2.36 (0.06) |
| Interventions |
1: FP 200mcg bid (100mcg bid)
2: FP 100mcg/day (50mcg bid)
3:FP 50mcg/day (25mcg bid)
4: placebo 2 puffs bid
Delivery device: pMDI
Duration of treatment: 12 weeks
Run in phase: 1 week placebo
Other: albuterol as needed, no other medications allowed |
| Outcomes |
PEF, FEV1, rescue medication, asthma symptoms including night symptoms, adverse events, withdrawal due to worsening asthma |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Described as randomised; other information not available |
