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Published on: May 10, 2024
Preemptive use of high-dose fluticasone for virus-induced wheezing in young children
Francine M Ducharme1, Chantal Lemire, Francisco J D Noya
1Applied Clinical Research Unit, Centre Hospitalier Universitaire Sainte-Justine, and the Department of Pediatrics, University of Montreal, Montreal, Quebec, Canada. francine.m.ducharme@umontreal.ca
Insights
Preemptive high-dose fluticasone reduced rescue corticosteroid use in children with virus-induced wheezing. However, it was linked to reduced growth, necessitating further study before clinical adoption.
Area of Science:
- Pediatric Pulmonology
- Respiratory Medicine
- Clinical Pharmacology
Background:
- Virus-induced wheezing is a common condition in preschool children, with management strategies still under development.
- Recurrent episodes necessitate effective and safe treatment options to reduce severity and healthcare utilization.
Purpose of the Study:
- To evaluate the efficacy and safety of preemptive high-dose fluticasone propionate in managing recurrent virus-induced wheezing in young children.
- To determine if early intervention with inhaled corticosteroids can decrease the need for rescue systemic corticosteroids.
Main Methods:
- A randomized controlled trial involving 129 children aged 1-6 years.
- Participants received either 750 mcg of fluticasone propionate or placebo twice daily at the onset of upper respiratory tract infections for up to 10 days.
- Primary outcome was rescue oral corticosteroid use; secondary outcomes included symptom scores, beta(2)-agonist use, acute care visits, hospitalizations, and growth parameters.
Main Results:
- Fluticasone treatment significantly reduced the need for rescue systemic corticosteroids (8% vs. 18% in placebo group).
- Children receiving fluticasone showed significantly smaller mean gains in height (z score difference: -0.24) and weight (z score difference: -0.26) compared to placebo.
- No significant differences were observed in basal cortisol levels, bone mineral density, or overall adverse events between the groups.
Conclusions:
- Preemptive high-dose fluticasone effectively reduces rescue oral corticosteroid use in preschool children experiencing moderate-to-severe virus-induced wheezing.
- The observed reduction in growth (height and weight) warrants caution regarding the widespread adoption of this preventive strategy.
- Further research is needed to clarify long-term adverse effects before this approach can be recommended for routine clinical practice.
Background:
Although virus-induced wheezing is common in preschool-age children, optimal management remains elusive. We examined the efficacy and safety of preemptive treatment with high-dose fluticasone in reducing the severity of recurrent virus-induced wheezing in children.
Methods:
We randomly assigned 129 children who were 1 to 6 years of age to receive 750 microg of fluticasone propionate (ex-valve [manufacturer-measured] dose) or placebo twice daily, beginning at the onset of an upper respiratory tract infection and continuing for a maximum of 10 days, over a period of 6 to 12 months. The primary outcome was rescue oral corticosteroid use. Secondary outcomes included symptoms, use of beta(2)-agonists, acute care visits, hospitalizations, discontinuation of the study drug, change in growth and bone mineral density, basal cortisol level, and adverse events.
Results:
Over a median period of 40 weeks, 8% of upper respiratory tract infections in the fluticasone group led to treatment with rescue systemic corticosteroids, as compared with 18% in the placebo group (odds ratio, 0.49; 95% confidence interval [CI], 0.30 to 0.83). Children who were treated with fluticasone, as compared with those who were given placebo, had smaller mean (+/-SD) gains from baseline in height (6.23+/-2.62 cm [unadjusted value]; z score, -0.19 +/-0.42 vs. 6.56+/-2.90 cm [unadjusted value]; z score, 0.00+/-0.48; difference between groups in z score from baseline to end point, -0.24 [95% CI, -0.40 to -0.08]) and in weight (1.53+/-1.17 kg [unadjusted value]; z score, -0.15+/-0.48 vs. 2.17+/-1.79 kg [unadjusted value]; z score, 0.11+/-0.43; difference between groups in z score from baseline to end point, -0.26 [95% CI, -0.41 to -0.09]). There were no significant differences between the groups in basal cortisol level, bone mineral density, or adverse events.
Conclusions:
In preschool-age children with moderate-to-severe virus-induced wheezing, preemptive treatment with high-dose fluticasone as compared with placebo reduced the use of rescue oral corticosteroids. Treatment with fluticasone was associated with a smaller gain in height and weight. Given the potential for overuse, this preventive approach should not be adopted in clinical practice until long-term adverse effects are clarified. (ClinicalTrials.gov number, NCT00238927.)
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