| Budesonide added to formoterol contributes to improved exercise tolerance in patients with COPD. | |
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MedLine Citation:
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PMID: 20692140 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Breathlessness and exercise intolerance frequently impact the daily life of patients with COPD. METHODS: This double-blind, multicentre, three-period crossover study randomised 111 patients with COPD (mean age 64 years, mean FEV(1) 38% of predicted normal) to budesonide/formoterol 320/9 microg, formoterol 9 microg or placebo, twice daily for 1 week, following a 1-week run-in period with 1-week wash-out between treatments. Terbutaline (0.5 mg/dose) was used as needed. The primary efficacy variable was exercise endurance time (EET) at 75% peak work capacity with cycle ergometry assessed 1 h post-morning dose. RESULTS: Budesonide/formoterol prolonged EET 1 h post-morning dose versus formoterol by 69 s (P < 0.005) and placebo by 105 s (P < 0.0001) and improved inspiratory capacity (IC) at isotime during exercise versus formoterol by 8% (P = 0.011) and placebo by 16% (P < 0.0001). Borg score at isotime was reduced by 0.48 (P = 0.12) and 0.78 (P = 0.014) compared with formoterol and placebo, respectively. At the repeated cycle test 6 h after morning dose, the effect on EET still favoured budesonide/formoterol over formoterol and placebo, while the isotime IC and Borg score were similar but better than placebo for the active study drugs. Budesonide/formoterol and formoterol improved health status (St George's Respiratory Questionnaire total score: mean difference versus placebo -2.4 and -2.2, respectively). All treatments were well tolerated. CONCLUSIONS: Budesonide/formoterol resulted in a significant improvement in endurance time 1 h after the last morning dose in a 1-week treatment period versus formoterol and placebo. This study demonstrates, for the first time, the benefit of inhaled corticosteroids in addition to long-acting beta(2)-agonists on exercise tolerance in COPD patients. www.clinicaltrials.gov registration number: NCT00489853. |
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Authors:
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Heinrich Worth; Karin Förster; Göran Eriksson; Ulf Nihlén; Stefan Peterson; Helgo Magnussen |
Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2010-08-07 |
Journal Detail:
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Title: Respiratory medicine Volume: 104 ISSN: 1532-3064 ISO Abbreviation: Respir Med Publication Date: 2010 Oct |
Date Detail:
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Created Date: 2010-09-06 Completed Date: 2011-02-24 Revised Date: 2013-06-11 |
Medline Journal Info:
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Nlm Unique ID: 8908438 Medline TA: Respir Med Country: England |
Other Details:
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Languages: eng Pagination: 1450-9 Citation Subset: IM |
Affiliation:
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Medical Department I, Fürth Hospital, Fürth, Germany. med1@klinikum-fuerth.de |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Inhalation Adult Aged Aged, 80 and over Bronchodilator Agents / administration & dosage* Budesonide / administration & dosage* Cross-Over Studies Double-Blind Method Drug Therapy, Combination / methods Dyspnea / drug therapy*, physiopathology Ethanolamines / administration & dosage* Exercise Test Exercise Tolerance / drug effects*, physiology Female Forced Expiratory Volume / drug effects, physiology Humans Male Middle Aged Pulmonary Disease, Chronic Obstructive / drug therapy*, physiopathology Questionnaires Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Bronchodilator Agents; 0/Ethanolamines; 51333-22-3/Budesonide; 5ZZ84GCW8B/formoterol |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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