Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study

BACKGROUND: The budesonide/formoterol combination is successfully used for fast relief of asthma symptoms in addition to its use as maintenance therapy. The temporarily increased corticosteroid dose during increasing inhaler use for symptom relief is likely to suppress any temporary increase in airw...

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Main Authors: Aalbers, René, Boorsma, Martin, van der Woude, Hanneke J, Jonkers, René E
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2010
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Research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC2890647/
https://ncbi.nlm.nih.gov/pubmed/20509942
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1465-9921-11-66
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spelling pubmed-28906472010-06-24 Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study Aalbers, René Boorsma, Martin van der Woude, Hanneke J Jonkers, René E Respir Res Research BACKGROUND: The budesonide/formoterol combination is successfully used for fast relief of asthma symptoms in addition to its use as maintenance therapy. The temporarily increased corticosteroid dose during increasing inhaler use for symptom relief is likely to suppress any temporary increase in airway inflammation and may mitigate or prevent asthma exacerbations. The relative contribution of the budesonide and formoterol components to the improved asthma control is unclear. METHODS: The acute protective effect of inhaled budesonide was tested in a model of temporarily increased airway inflammation with repeated indirect airway challenges, mimicking an acute asthma exacerbation. A randomised, double-blind, cross-over study design was used. Asthmatic patients (n = 17, mean FEV(1 )95% of predicted) who previously demonstrated a ≥30% fall in forced expiratory volume in 1 second (FEV(1)) after inhaling adenosine 5'-monophosphate (AMP), were challenged on four consecutive test days, with the same dose of AMP (at 09:00, 12:00 and 16:00 hours). Within 1 minute of the maximal AMP-induced bronchoconstriction at 09:00 hours, the patients inhaled one dose of either budesonide/formoterol (160/4.5 μg), formoterol (4.5 μg), salbutamol (2 × 100 μg) or placebo. The protective effects of the randomised treatments were assessed by serial lung function measurements over the test day. RESULTS: In the AMP provocations at 3 and 7 hours after inhalation, the budesonide/formoterol combination provided a greater protective effect against AMP-induced bronchoconstriction compared with formoterol alone, salbutamol and placebo. In addition all three active treatments significantly increased FEV(1 )within 3 minutes of administration, at a time when inhaled AMP had induced the 30% fall in FEV(1). CONCLUSIONS: A single dose of budesonide/formoterol provided a greater protective effect against inhaled AMP-induced bronchoconstriction than formoterol alone, both at 3 and at 7 hours after inhalation. The acute protection against subsequent bronchoconstrictor stimuli such as inhaled AMP and the rapid reversal of airway obstruction supports the use of budesonide/formoterol for both relief and prevention in the treatment of asthma. TRIAL REGISTRATION: ClinicalTrials.gov number NCT00272753 BioMed Central 2010 2010-05-28 /pmc/articles/PMC2890647/ /pubmed/20509942 http://dx.doi.org/10.1186/1465-9921-11-66 Text en Copyright ©2010 Aalbers et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
institution US NLM
collection PubMed Central
language Inglês
format Artigo
topic Research
spellingShingle Research
Aalbers, René
Boorsma, Martin
van der Woude, Hanneke J
Jonkers, René E
Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study
description BACKGROUND: The budesonide/formoterol combination is successfully used for fast relief of asthma symptoms in addition to its use as maintenance therapy. The temporarily increased corticosteroid dose during increasing inhaler use for symptom relief is likely to suppress any temporary increase in airway inflammation and may mitigate or prevent asthma exacerbations. The relative contribution of the budesonide and formoterol components to the improved asthma control is unclear. METHODS: The acute protective effect of inhaled budesonide was tested in a model of temporarily increased airway inflammation with repeated indirect airway challenges, mimicking an acute asthma exacerbation. A randomised, double-blind, cross-over study design was used. Asthmatic patients (n = 17, mean FEV(1 )95% of predicted) who previously demonstrated a ≥30% fall in forced expiratory volume in 1 second (FEV(1)) after inhaling adenosine 5'-monophosphate (AMP), were challenged on four consecutive test days, with the same dose of AMP (at 09:00, 12:00 and 16:00 hours). Within 1 minute of the maximal AMP-induced bronchoconstriction at 09:00 hours, the patients inhaled one dose of either budesonide/formoterol (160/4.5 μg), formoterol (4.5 μg), salbutamol (2 × 100 μg) or placebo. The protective effects of the randomised treatments were assessed by serial lung function measurements over the test day. RESULTS: In the AMP provocations at 3 and 7 hours after inhalation, the budesonide/formoterol combination provided a greater protective effect against AMP-induced bronchoconstriction compared with formoterol alone, salbutamol and placebo. In addition all three active treatments significantly increased FEV(1 )within 3 minutes of administration, at a time when inhaled AMP had induced the 30% fall in FEV(1). CONCLUSIONS: A single dose of budesonide/formoterol provided a greater protective effect against inhaled AMP-induced bronchoconstriction than formoterol alone, both at 3 and at 7 hours after inhalation. The acute protection against subsequent bronchoconstrictor stimuli such as inhaled AMP and the rapid reversal of airway obstruction supports the use of budesonide/formoterol for both relief and prevention in the treatment of asthma. TRIAL REGISTRATION: ClinicalTrials.gov number NCT00272753
author Aalbers, René
Boorsma, Martin
van der Woude, Hanneke J
Jonkers, René E
author_facet Aalbers, René
Boorsma, Martin
van der Woude, Hanneke J
Jonkers, René E
author_sort Aalbers, René
title Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study
title_short Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study
title_full Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study
title_fullStr Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study
title_full_unstemmed Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study
title_sort protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled amp in patients with asthma: a randomised, double-blind, cross-over study
publisher BioMed Central
publishDate 2010
url https://ncbi.nlm.nih.gov/pmc/articles/PMC2890647/
https://ncbi.nlm.nih.gov/pubmed/20509942
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1465-9921-11-66
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