CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Do inhaled corticosteroids impair long-term growth in prepubertal cystic fibrosis patients?

Study design (if review, criteria of inclusion for studies)

prospective double-blind case-controlled study

Participants

27 prepubertal CF children with mild to moderate lung disease

Interventions

fluticasone propionate 500 microg or placebo were administered twice daily during 12 months

Outcome measures

FEV1 (% pred), n° respiratory exacerbations, height

Main results

The mean (standard error of the mean, SEM) patient age was 8.2 (0.6) years in the placebo group and 9.0 (0.5) years in the fluticasone group. The mean (SEM) forced expiratory volume in 1 s (FEV(1)) was 91% (4%) in the placebo group and 86% (4%) in the fluticasone group. There was no statistically significant difference in the evolution of lung function and the number of respiratory exacerbations between groups. However, longitudinal growth in fluticasone patients was significantly slower than in placebo patients: 3.96 (0.29) cm versus 5.49 (0.38) cm [p<0.005, analysis of variance (ANOVA)] over the 12-month study duration. This resulted in a significant change in height standard deviation score (SDS) of -0.38 (0.09) in the fluticasone group versus -0.01 (0.07) in the placebo group (p<0.003, ANOVA). No catch-up growth was noted 1-2 years after discontinuation of inhaled steroids.

Authors' conclusions

The use of high-dose ICS in CF patients with mild lung disease may lead to persistent growth impairment.

Keywords: Adolescent; Adult; Budesonide; Hormones; Inhalation OR nebulised; pharmacological_intervention; Pregnenediones; Respiratory Tract Diseases; Steroids; Anti-Inflammatory Agents;