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. 2004 Apr 19;2004(2):CD004109. doi: 10.1002/14651858.CD004109.pub2

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