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Objective: To evaluate efficacy, safety, health outcomes, and cost-effectiveness of fluticasone propionate (FP) versus montelukast (MON) in 342 children (6 to 12 years of age) with persistent asthma., Study Design: Randomized, double-blind, 12-week study of treatment with FP inhalation powder 50 mug twice daily or MON chewable 5 mg once daily for 12 weeks., Results: Compared with MON, FP significantly increased mean percent change from baseline FEV1 (forced expiratory volume in 1 second) (P=.002), morning PEF (peak expiratory flow) (P=.004), evening PEF (P=.020), and percent rescue-free days (P=.002) at end point, and it significantly reduced nighttime symptom scores (P <.001) and mean total (P=.018), and nighttime (P <.001) albuterol use. Withdrawals from the study were more frequent with MON (21%) than with FP (13%). Adverse events (69% vs 71%) and mean end point to baseline 12-hour urinary cortisol excretion ratios were similar. Parents and physicians were more satisfied with FP treatment than with MON (P=.006 and P=.016, respectively, at Week 12). Mean total daily asthma-related cost per patient in the FP group was approximately one-third of that in the MON group ($1.25 vs $3.49)., Conclusion: FP was significantly more effective than MON in improving pulmonary function, asthma symptoms, and rescue albuterol use. Both therapies had similar safety profiles. Parent- and physician-reported satisfaction ratings were higher with FP treatment, and asthma-related costs were lower.

Twenty-one low-risk outpatient asthmatics were challenged with 650 mg. of aspirin (ASA) and placebo in a double-blind manner. Methacholine dose response curves were performed after both aspirin and placebo administration. Baseline FEV1 was similar before aspirin and placebo challenges. No adverse clinical reactions were noted. No patient had a positive ASA challenge with a greater than 20% decrease in FEV1. Aspirin had no effect on bronchial reactivity that could be measured by a change in methacholine responsiveness.

In order to study whether the methacholine inhalation challenge could predict which patients with allergic rhinitis were at risk to develop asthma, we prospectively studied a group of ragweed-sensitive patients over a four to five year period. On the initial study, 16 of 40 patients (40 percent) were found to be hyperresponsive to methacholine. On the follow-up study, three of these 16 patients (19 percent) were found to have developed asthma from one and one-half to five years after the initial testing. Each had greater methacholine responsiveness on repeat study. The degree of methacholine hyperresponsiveness, judged by the PD20, could not predict which of the initial responders would develop asthma. Twenty-four (60 percent) of our patients showed normal responses to methacholine on initial study; none developed asthma and 88 percent remained nonresponders on repeat study. Our study shows that allergic rhinitis patients hyperresponsive to methacholine are at greater risk to develop asthma than those with normal bronchial challenges (p less than 0.05).