RESUMO
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.
Assuntos
Androstadienos/administração & dosagem , Anti-Inflamatórios/administração & dosagem , Asma/tratamento farmacológico , Pulmão/efeitos dos fármacos , Sons Respiratórios/efeitos dos fármacos , Administração por Inalação , Androstadienos/efeitos adversos , Anti-Inflamatórios/efeitos adversos , Asma/fisiopatologia , Estudos de Casos e Controles , Método Duplo-Cego , Feminino , Fluticasona , Volume Expiratório Forçado/efeitos dos fármacos , Humanos , Lactente , Pulmão/fisiopatologia , Masculino , Recidiva , Sons Respiratórios/imunologiaRESUMO
Background: Inhaled corticosteroids are used to treat infants with trouble some 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 end point) of once-daily inhaled fluticasone (375g) 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 375g 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 trouble some asthma-like symptoms (AU)
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Assuntos
Humanos , Masculino , Feminino , Criança , Asma/tratamento farmacológico , Antiasmáticos/administração & dosagem , Corticosteroides/administração & dosagem , Administração por Inalação , Testes de Função Respiratória , Predisposição Genética para DoençaRESUMO
The efficacy of beclomethasone dipropionate (BDP) to control respiratory symptoms was evaluated in 31 children under age 2 years with recurrent wheezing. The study was conducted in a double-blind, parallel, and placebo-controlled fashion. The two study groups received either salbutamol plus BDP 200 microg bid by metered dose inhaler (MDI) with a spacer, or salbutamol MDI plus a placebo. Inhaled corticosteroid (IC) and placebo were administered for 8 weeks. Patients were seen every 2 weeks as outpatients, and their progress was evaluated by clinical examination and a daily symptom score card. At the end of the study, patients in both groups had significantly decreased symptoms. No significant difference was found between BDP and placebo groups regarding clinical score, number of salbutamol doses, sleep disturbances, number of symptom-free days, feelings of insecurity of mothers regarding the infants' life due to wheezing, and mothers' perceptions of progress in their infants' respiratory symptoms. We conclude that salbutamol plus 200 microg bid of BDP inhaled from an MDI with a spacer for 8 weeks is no better than salbutamol alone for decreasing recurrent wheezing in small children under age 24 months.
Assuntos
Albuterol/administração & dosagem , Antiasmáticos/administração & dosagem , Beclometasona/administração & dosagem , Broncodilatadores/administração & dosagem , Administração por Inalação , Albuterol/uso terapêutico , Antiasmáticos/uso terapêutico , Beclometasona/uso terapêutico , Broncodilatadores/uso terapêutico , Pré-Escolar , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Nebulizadores e Vaporizadores , Sons Respiratórios/efeitos dos fármacosRESUMO
La variablidad en la función de jet nebulizadores de la misma marca y modelo (Hudson UP-DRAFT II, modelo 1730), fue evaluada en relación al gasto o débito (mg/min.) producida al emplear un volumen de llenado de 2 o 4 ml de solución salina normal. La variabilidad intranebulizadores observada en nebulizaciones repetidas no fue significativa. La variabilidad observada en los gastos entre los distintos jet nebulizadores fue estadisticamente significativa (p< 0.05). Sin embargo esta variabilidad fue mayor cuando se emplearon 2 ml de volumen de llenado (p< 0.001). Además se observó una disminución significativa del gasto durante el período de nebulización en todos los nebulizadores estudiados (p< 0.001). Esta disminución fue de mayor magnitud y variabilidad cuando los nebulizadores se emplearon con 2 ml. Este estudio sugiere que parte de la variabilidad observada en los resultados de trabajo clínicos y de laboratorio, que han empleado aerosoles generados por jet nebulizadores, se debería a la variabilidad existente entre los nebulizadores y en las condiciones de manejo de estos dispositivos. Lo anterior refuerza la necesidad de conocer previamente las características de funcionamiento de los sistemas de nebulización. Ambos, el nebulizador y las condiciones de manejo, necesitan ser previamente determinados cuando se evalúa la acción farmacológica de agentes terapéuticos nebulizados generados por jet nebulizadores