Noonan 1998.
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: multicentre No eligible: Not stated No randomised: 138 (33/34/35/36) No completed: 119 (30/30/31/28) Sex: Males: 84 (61%); Females: 54 (39%). Age: mean 23;29;30;26 Range: 12‐59 Diagnostic criteria for asthma: ATS Inclusion criteria: >= 12 yrs old, 6 month history asthma, documented history of allergy, FEV1 between 60 and 85% predicted, >= 15% reversability, positive PD20(methacholine) . Exclusion criteria: recent hospitalisation for asthma, corticosteroid use, oral theophylline, inhaled cromolyn, nedocromil,, smokers, significant concurrent disease,, pregnancy or lactation. Baseline severity of asthma: FEV1: 74;73;76;74 percent predicted | |
Interventions | 1: FP (10% lecithin) 200mcg/day
2: FP (1% Lecithin) 200mcg/day
3: FP (1% Lecithin) 100mcg/day
4: Placebo (1% Lecithin) 2 puffs day
Delivery device: pMDI
Duration of treatment: 8 weeks
Run in phase: 2 weeks Other: Albuterol and oral terfanadine as needed |
|
Outcomes | FEV1, PEF, AHR, rescue medications, nocturnal asthma, symptoms | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised; other information not available |