Allergologia et immunopathologia · 2009
Effect of inhaled fluticasone on lung function in infants with recurrent wheezing: a randomised controlled trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Mallol Javier, Aguirre Viviana, Barrueto Luis, Wandalsen Gustavo, Tepper Robert
Аннотация
BACKGROUND: Inhaled corticosteroids are used to treat infants with troublesome asthma-like symptoms but their effect on the lung function of these young patients is controversial.
MATERIAL AND METHODS: Forty-four infants with recurrent wheezing (more than 3 episodes) and family history of asthma completed this randomised, parallel, double-blind, controlled trial to compare the effect on lung function (main endpoint) of once-daily inhaled fluticasone (375 microg) versus placebo for 3 months. Pulmonary function was measured while infants were asymptomatic, using the raised volume rapid thoracic compression technique (spirometry-like), and values were converted to z-scores.
RESULTS: The fluticasone group showed a significant increase in forced flows, (p < 0.001), a lower number of physician diagnosed wheezing episodes (p < 0.002), and a significant decrease in the parent-reported number of wheezing episodes per month (p < 0.03), as compared to placebo. One third of parents in the placebo group reported a clinical improvement in their infants. There was no significant difference in morning plasma cortisol between groups at entry or discharge.
CONCLUSIONS: We conclude that once-daily treatment with 375 microg fluticasone increased forced flows and controlled symptoms in infants with recurrent wheezing without altering plasma cortisol levels. The spirometry-like technique is a useful tool to objectively assess the efficacy of anti-asthma medications in infants with repeated troublesome asthma-like symptoms.
MATERIAL AND METHODS: Forty-four infants with recurrent wheezing (more than 3 episodes) and family history of asthma completed this randomised, parallel, double-blind, controlled trial to compare the effect on lung function (main endpoint) of once-daily inhaled fluticasone (375 microg) versus placebo for 3 months. Pulmonary function was measured while infants were asymptomatic, using the raised volume rapid thoracic compression technique (spirometry-like), and values were converted to z-scores.
RESULTS: The fluticasone group showed a significant increase in forced flows, (p < 0.001), a lower number of physician diagnosed wheezing episodes (p < 0.002), and a significant decrease in the parent-reported number of wheezing episodes per month (p < 0.03), as compared to placebo. One third of parents in the placebo group reported a clinical improvement in their infants. There was no significant difference in morning plasma cortisol between groups at entry or discharge.
CONCLUSIONS: We conclude that once-daily treatment with 375 microg fluticasone increased forced flows and controlled symptoms in infants with recurrent wheezing without altering plasma cortisol levels. The spirometry-like technique is a useful tool to objectively assess the efficacy of anti-asthma medications in infants with repeated troublesome asthma-like symptoms.