Signs and Symptoms that Precede Wheezing in Children with a Pattern of Moderate-to-Severe Intermittent Wheezing

Rivera-Spoljaric, Katherine; Chinchilli, Vernon M.; Camera, Lindsay; Zeiger, Robert S.; Paul, Ian M.; Phillips, Brenda R.; Taussig, Lynn M.; Strunk, Robert C.; Bacharier, Leonard B.

doi:10.1016/j.jpeds.2008.12.029

Cited by 20 publications

(10 citation statements)

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“…Parents or guardians were provided with an individualized care plan, developed with the study team, that instructed starting study therapy as soon as participants developed the symptoms or signs that parents or guardians defined as the child’s usual starting point before the development of a severe LRTI. 13-15 During RTIs, all participants received albuterol inhalation treatments 4 times daily while awake for the first 48 hours as well as whenever needed at any time during the RTI. 13-15 …”

Section: Methodsmentioning

confidence: 99%

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Early Administration of Azithromycin and Prevention of Severe Lower Respiratory Tract Illnesses in Preschool Children With a History of Such Illnesses

Bacharier

Guilbert

Mauger

et al. 2015

JAMA

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253

161

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IMPORTANCE Many preschool children develop recurrent, severe episodes of lower respiratory tract illness (LRTI). Although viral infections are often present, bacteria may also contribute to illness pathogenesis. Strategies that effectively attenuate such episodes are needed. OBJECTIVE To evaluate if early administration of azithromycin, started prior to the onset of severe LRTI symptoms, in preschool children with recurrent severe LRTIs can prevent the progression of these episodes. DESIGN, SETTING, AND PARTICIPANTS A randomized, double-blind, placebo-controlled, parallel-group trial conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute’s AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by December 2014. Participants were 607 children aged 12 through 71 months with histories of recurrent, severe LRTIs and minimal day-to-day impairment. INTERVENTION Participants were randomly assigned to receive azithromycin (12 mg/kg/d for 5 days; n = 307) or matching placebo (n = 300), started early during each predefined RTI (child’s signs or symptoms prior to development of LRTI), based on individualized action plans, over a 12-through 18-month period. MAIN OUTCOMES AND MEASURES The primary outcome measure was the number of RTIs not progressing to a severe LRTI, measured at the level of the RTI, that would in clinical practice trigger the prescription of oral corticosteroids. Presence of azithromycin-resistant organisms in oropharyngeal samples, along with adverse events, were among the secondary outcome measures. RESULTS A total of 937 treated RTIs (azithromycin group, 473; placebo group, 464) were experienced by 443 children (azithromycin group, 223; placebo group, 220), including 92 severe LRTIs (azithromycin group, 35; placebo group, 57). Azithromycin significantly reduced the risk of progressing to severe LRTI relative to placebo (hazard ratio, 0.64 [95% CI, 0.41-0.98], P = .04; absolute risk for first RTI: 0.05 for azithromycin, 0.08 for placebo; risk difference, 0.03 [95% CI, 0.00-0.06]). Induction of azithromycin-resistant organisms and adverse events were infrequently observed. CONCLUSIONS AND RELEVANCE Among young children with histories of recurrent severe LRTIs, the use of azithromycin early during an apparent RTI compared with placebo reduced the likelihood of severe LRTI. More information is needed on the development of antibiotic-resistant pathogens with this strategy.

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Section: Methodsmentioning

confidence: 99%

“…13-15 During RTIs, all participants received albuterol inhalation treatments 4 times daily while awake for the first 48 hours as well as whenever needed at any time during the RTI. 13-15 …”

Section: Methodsmentioning

confidence: 99%

Early Administration of Azithromycin and Prevention of Severe Lower Respiratory Tract Illnesses in Preschool Children With a History of Such Illnesses

Bacharier

Guilbert

Mauger

et al. 2015

JAMA

Self Cite

253

161

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“…11,19 Parents began a 7-day course of intermittent study medication at the onset of symptoms or signs of a respiratory tract illness that they identified as their child’s usual starting point before the development of wheezing (Fig. S2 in the Supplementary Appendix).…”

Section: Methodsmentioning

confidence: 99%

Daily or Intermittent Budesonide in Preschool Children with Recurrent Wheezing

et al. 2011

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BACKGROUND Daily inhaled glucocorticoids are recommended for young children at risk for asthma exacerbations, as indicated by a positive value on the modified asthma predictive index (API) and an exacerbation in the preceding year, but concern remains about daily adherence and effects on growth. We compared daily therapy with intermittent therapy. METHODS We studied 278 children between the ages of 12 and 53 months who had positive values on the modified API, recurrent wheezing episodes, and at least one exacerbation in the previous year but a low degree of impairment. Children were randomly assigned to receive a budesonide inhalation suspension for 1 year as either an intermittent high-dose regimen (1 mg twice daily for 7 days, starting early during a predefined respiratory tract illness) or a daily low-dose regimen (0.5 mg nightly) with corresponding placebos. The primary outcome was the frequency of exacerbations requiring oral glucocorticoid therapy. RESULTS The daily regimen of budesonide did not differ significantly from the intermittent regimen with respect to the frequency of exacerbations, with a rate per patient-year for the daily regimen of 0.97 (95% confidence interval [CI], 0.76 to 1.22) versus a rate of 0.95 (95% CI, 0.75 to 1.20) for the intermittent regimen (relative rate in the intermittent-regimen group, 0.99; 95% CI, 0.71 to 1.35; P=0.60). There were also no significant between-group differences in several other measures of asthma severity, including the time to the first exacerbation, or adverse events. The mean exposure to budesonide was 104 mg less with the intermittent regimen than with the daily regimen. CONCLUSIONS A daily low-dose regimen of budesonide was not superior to an intermittent high-dose regimen in reducing asthma exacerbations. Daily administration led to greater exposure to the drug at 1 year.

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“…4 Furthermore, because our participants were enrolled at 93 centers worldwide, the difficulty in perception, interpretation, or both of wheeze by caregivers appeared to be universal and not a nationally or culturally determined phenomenon.…”

Section: To the Editormentioning

confidence: 99%