title: Anti-inflammatory effects of combined budesonide/formoterol in COPD exacerbations.
abstract: Systemic corticosteroids and additional short-acting beta2-agonists are commonly used in exacerbations of chronic obstructive pulmonary disease (COPD). In this double-blind study, the combination of a high-dose inhaled corticosteroid with a rapid-onset long-acting beta2-agonist was evaluated in the treatment of out-patient COPD exacerbations. The primary aim was to compare 14-day treatment effects of budesonide/formoterol to placebo on sputum eosinophils and, secondarily, on other indices of inflammation, forced expiratory flow in one second (FEV(1)), symptoms, health status, and adverse events. Forty-five patients not using steroids (37 male, 21/24 current/ex smoker, median packyears 38, age 65 years, FEV(1) 61% predicted), experiencing a COPD exacerbation, were treated at home with budesonide/formoterol (320/9 microg 4 times daily), prednisolone (30 mg daily), or placebo for 14 days. Sputum eosinophils were significantly reduced by budesonide/formoterol (-57%) compared to placebo (+24%) (p = 0.01). Budesonide/formoterol reduced total symptom scores significantly (p = 0.01) compared to placebo. The increase in FEV(1) by 2 weeks of treatment with budesonide/formoterol (125 ml) was not significantly different from that of placebo (43 ml) (p = 0.07). Budesonide/ formoterol treatment did not suppress morning serum cortisol compared to placebo (-16%; p = 0.50). In conclusion, budesonide/formoterol reduces sputum eosinophils and improves symptoms in the treatment of out-patient COPD exacerbations.
authors.affiliation: Groningen Research Institute for Asthma and COPD, Department of Pulmonology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. ebathoorn@gmail.com
authors.forename: Erik
authors.initials: E
authors.lastname: Bathoorn
authors.forename: Jeroen J W
authors.initials: JJ
authors.lastname: Liesker
authors.forename: Dirkje S
authors.initials: DS
authors.lastname: Postma
authors.forename: Martin
authors.initials: M
authors.lastname: Boorsma
authors.forename: Eva
authors.initials: E
authors.lastname: Bondesson
authors.forename: Gerard H
authors.initials: GH
authors.lastname: Koëter
authors.forename: Henk F
authors.initials: HF
authors.lastname: Kauffman
authors.forename: Antoon J M
authors.initials: AJ
authors.lastname: van Oosterhout
authors.forename: Huib A M
authors.initials: HA
authors.lastname: Kerstjens
mesh_terms: D000280:Administration, Inhalation; D000284:Administration, Oral; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D019819:Budesonide / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004804:Eosinophils / Q000187:drug effects / Q000378:metabolism; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000008:administration & dosage; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000378:metabolism; D012129:Respiratory Function Tests; D013183:Sputum / Q000737:chemistry; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D001993:Bronchodilator Agents; D004338:Drug Combinations; D004983:Ethanolamines; D019819:Budesonide; D011239:Prednisolone; D000068759:Formoterol Fumarate