OBJECTIVE: The therapeutic benefit of inhaled corticoids in bronchiectasis not due to cystic fibrosis is still not well documented. The aim of the present study was to assess the efficacy and safety of inhaled corticoids in this disease. SETTING: This study was conducted at a tertiary university hospital in the city of Barcelona, Catalonia, (Spain). METHOD: A prospective, double-blind, parallel, placebo-masked study was conducted. Seventy-seven patients (40 women; mean age: 68 years) were randomly assigned to receive either 400 mcg budesonide twice daily or placebo and were regularly reviewed for six months. RESULTS: Differences in forced vital capacity and forced expiratory volume in the first second between the beginning and end of the study were not significantly lower in the budesonide group than in the placebo group, either in absolute values [-17.4 (386.9) versus -21.4 (375.5)] or in percentages [-1.9(9.5) versus -2.8 (11.6)]. Microbiological criteria applied to evaluate changes between the beginning and end of the study showed no worsening in the budesonide group compared with the control group, whereas a non-significant improvement was obtained in 8.1 % of cases in the budesonide group compared to 3 % in the placebo group. Although significance was only achieved for sputum eosinophils (p = 0.021), a consistent tendency towards improvement was also observed in secondary end-points (symptoms, number and duration of exacerbations, quality of life, sputum cytology and interleukin-8) in the budesonide group. CONCLUSION: Although further studies are required, inhaled corticoid treatment may be efficacious and safe in bronchiectasis not due to cystic fibrosis.
RCT Entities:
OBJECTIVE: The therapeutic benefit of inhaled corticoids in bronchiectasis not due to cystic fibrosis is still not well documented. The aim of the present study was to assess the efficacy and safety of inhaled corticoids in this disease. SETTING: This study was conducted at a tertiary university hospital in the city of Barcelona, Catalonia, (Spain). METHOD: A prospective, double-blind, parallel, placebo-masked study was conducted. Seventy-seven patients (40 women; mean age: 68 years) were randomly assigned to receive either 400 mcg budesonide twice daily or placebo and were regularly reviewed for six months. RESULTS: Differences in forced vital capacity and forced expiratory volume in the first second between the beginning and end of the study were not significantly lower in the budesonide group than in the placebo group, either in absolute values [-17.4 (386.9) versus -21.4 (375.5)] or in percentages [-1.9(9.5) versus -2.8 (11.6)]. Microbiological criteria applied to evaluate changes between the beginning and end of the study showed no worsening in the budesonide group compared with the control group, whereas a non-significant improvement was obtained in 8.1 % of cases in the budesonide group compared to 3 % in the placebo group. Although significance was only achieved for sputum eosinophils (p = 0.021), a consistent tendency towards improvement was also observed in secondary end-points (symptoms, number and duration of exacerbations, quality of life, sputum cytology and interleukin-8) in the budesonide group. CONCLUSION: Although further studies are required, inhaled corticoid treatment may be efficacious and safe in bronchiectasis not due to cystic fibrosis.
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Authors: Andrea Gramegna; Stefano Aliberti; Manuela Seia; Luigi Porcaro; Vera Bianchi; Carlo Castellani; Paola Melotti; Claudio Sorio; Enza Consalvo; Elisa Franceschi; Francesco Amati; Martina Contarini; Michele Gaffuri; Luca Roncoroni; Barbara Vigone; Angela Bellofiore; Cesare Del Monaco; Martina Oriano; Leonardo Terranova; Maria Francesca Patria; Paola Marchisio; Baroukh M Assael; Francesco Blasi Journal: Multidiscip Respir Med Date: 2018-08-09