Study of montelukast for the treatment of respiratory symptoms of post-respiratory syncytial virus bronchiolitis in children.

RATIONALE: A pilot study (Bisgaard H; Study Group on Montelukast and Respiratory Syncytial Virus. A randomized trial of montelukast in respiratory syncytial virus postbronchiolitis. Am J Respir Crit Care Med 2003;167:379-383) reported the efficacy of montelukast in post-respiratory syncytial virus (RSV) bronchiolitic respiratory symptoms. OBJECTIVES: To evaluate the efficacy and safety of montelukast, 4 and 8 mg, in treating recurrent respiratory symptoms of post-RSV bronchiolitis in children in a large, multicenter study. METHODS: This was a double-blind study of 3- to 24-month-old children who had been hospitalized for a first or second episode of physician-diagnosed RSV bronchiolitis and who tested positive for RSV. Patients (n = 979) were randomized to placebo or to montelukast at 4 or 8 mg/day for 4 weeks (period I) and 20 weeks (period II). The primary end point was percentage symptom-free days (%SFD; day with no daytime cough, wheeze, and shortness of breath, and no nighttime cough). MEASUREMENTS AND MAIN RESULTS: No significant differences were seen between montelukast and placebo in %SFD over period I: mean +/- SD for placebo and for montelukast at 4 and 8 mg were 37.0 +/- 30.7, 38.6 +/- 30.4, and 38.5 +/- 29.9, respectively. Least-squares mean differences (95% confidence interval) between montelukast (4 mg) and placebo and between montelukast (8 mg) and placebo were 1.9% (-2.9, 6.7) and 1.6% (-3.2, 6.5), respectively. Secondary end points were similar across treatments. Both doses were generally well tolerated. During the first two treatment weeks, average %SFD was approximately 29%. In post hoc analyses of patients (n = 523) with persistent symptoms (%SFD < or = 30% over Weeks 1-2), differences in %SFD were seen between montelukast and placebo over Weeks 3-24: difference were 5.7 (0.0, 11.3) for montelukast (4 mg) minus placebo and 5.9 (0.1, 11.7) for montelukast (8 mg) minus placebo. CONCLUSIONS: In this study, montelukast did not improve respiratory symptoms of post-RSV bronchiolitis in children.

Disagreement among common measures of asthma control in children.

BACKGROUND: Asthma is a worldwide problem. It cannot be prevented or cured, but it is possible, at least in principle, to control asthma with modern management. Control usually is assessed by history of symptoms, physical examination, and measurement of lung function. A practical problem is that these measures of control may not be in agreement. The aim of this study was to describe agreement among different measures of asthma control in children. METHODS: A prospective sequential sample of children aged 4 to 11 years with atopic asthma attending a routine follow-up evaluation were studied. Patients were assessed with the following four steps: (1) fraction of exhaled nitric oxide (FENO), (2) spirometry, (3) Childhood Asthma Control Test (cACT), and (4) conventional clinical assessment by a pediatrician. The outcome for each test was coded as controlled or uncontrolled asthma. Agreement among measures was examined by cross-tabulation and κ statistics. RESULTS: Eighty children were enrolled, and nine were excluded. Mean FENO in pediatrician-judged uncontrolled asthma was double that of controlled asthma (37 parts per billion vs 15 parts per billion, P < .005). There was disagreement among measures of control. Spirometric indices revealed some correlation, but of the unrelated comparisons, those that agreed with each other most often (69%) were clinical assessment by the pediatrician and the cACT. Worst agreement was noted for FENO and cACT (49.3%). CONCLUSION: Overall, different measures to assess control of asthma showed a lack of agreement for all comparisons in this study.