Background: Airway inflammation plays a central role in the pathogenesis of asthma, even in the mildest forms and at the earliest stages. Therapeutic strategies now aim to relieve bronchoconstriction as well as focus primarily on controlling the underlying inflammatory process. Clinical trials of children and adults with asthma have demonstrated that inhaled corticosteroids and cromones (such as nedocromil sodium [NS]) improve symptoms and lung function, as well as decrease nonspecific bronchial hyperresponsiveness. Objective: The aim of this study was to compare the effects of various antiinflammatory therapeutic regimens using inhaled fluticasone propionate (FP) and/or NS on airway hyperresponsiveness to methacholine. Methods: Patients with mild, persistent asthma., who tested positive to a Dermatophagoides pteronyssinus skin prick test, were randomly assigned to 1 of 4 treatment groups: (1) FP for 16 weeks; (2) FP for 8 weeks, followed by NS for 8 weeks; (3) NS for 8 weeks, followed by FP for 8 weeks, or (4) NS for 16 weeks. Each patient was evaluated every 4 weeks. Results: Thirty-two patients with asthma (16 men and 16 women; age range, 18-48 years) were included in the study; 8 patients were randomly assigned to each of the 4 treatment groups. During treatment with FP alone, the provocative dose of methacholine required to induce a 20% decrease in forced expiratory volume in 1 second (PD20) was significantly higher than that recorded during treatment with NS alone (P < 0.05 at weeks 12 and 16). However, both drugs induced progressive increases in PD20 versus baseline values throughout the study. Moreover, when FP was administered as the second drug (after NS), a further increase in PD20 compared with the values at week 8 occurred at both week 12 (P < 0.01) and week 16 (P < 0.001). In contrast, when NS was administered after 8 weeks of treatment with FP, methacholine PD20 decreased significantly compared with week 8 (P < 0.001 and P < 0.01 at weeks 12 and 16, respectively). Conclusions: Our results suggest that, in this limited population of asthmatic patients who were treated for 16 weeks, FP was effective in increasing the PD20 and that NS exerted an effective, progressive protective action against bronchial hyperresponsiveness to methacholine, thereby partially limiting the negative consequences of FP withdrawal on airway inflammation.

A single-blind, partial crossover clinical trial of the effects of inhaled fluticasone propionate and nedocromil sodium on airway hyperresponsiveness to methacholine

VATRELLA, Alessandro;
2002-01-01

Abstract

Background: Airway inflammation plays a central role in the pathogenesis of asthma, even in the mildest forms and at the earliest stages. Therapeutic strategies now aim to relieve bronchoconstriction as well as focus primarily on controlling the underlying inflammatory process. Clinical trials of children and adults with asthma have demonstrated that inhaled corticosteroids and cromones (such as nedocromil sodium [NS]) improve symptoms and lung function, as well as decrease nonspecific bronchial hyperresponsiveness. Objective: The aim of this study was to compare the effects of various antiinflammatory therapeutic regimens using inhaled fluticasone propionate (FP) and/or NS on airway hyperresponsiveness to methacholine. Methods: Patients with mild, persistent asthma., who tested positive to a Dermatophagoides pteronyssinus skin prick test, were randomly assigned to 1 of 4 treatment groups: (1) FP for 16 weeks; (2) FP for 8 weeks, followed by NS for 8 weeks; (3) NS for 8 weeks, followed by FP for 8 weeks, or (4) NS for 16 weeks. Each patient was evaluated every 4 weeks. Results: Thirty-two patients with asthma (16 men and 16 women; age range, 18-48 years) were included in the study; 8 patients were randomly assigned to each of the 4 treatment groups. During treatment with FP alone, the provocative dose of methacholine required to induce a 20% decrease in forced expiratory volume in 1 second (PD20) was significantly higher than that recorded during treatment with NS alone (P < 0.05 at weeks 12 and 16). However, both drugs induced progressive increases in PD20 versus baseline values throughout the study. Moreover, when FP was administered as the second drug (after NS), a further increase in PD20 compared with the values at week 8 occurred at both week 12 (P < 0.01) and week 16 (P < 0.001). In contrast, when NS was administered after 8 weeks of treatment with FP, methacholine PD20 decreased significantly compared with week 8 (P < 0.001 and P < 0.01 at weeks 12 and 16, respectively). Conclusions: Our results suggest that, in this limited population of asthmatic patients who were treated for 16 weeks, FP was effective in increasing the PD20 and that NS exerted an effective, progressive protective action against bronchial hyperresponsiveness to methacholine, thereby partially limiting the negative consequences of FP withdrawal on airway inflammation.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11386/3823479
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