| Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. | |
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MedLine Citation:
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PMID: 17905575 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Budesonide/formoterol maintenance and reliever therapy (Symbicort SMART) improves asthma control compared with fixed-dose inhaled corticosteroid/long-acting beta(2)-agonist (ICS/LABA) regimens, but its efficacy has not been assessed in comparison with sustained high-dose salmeterol/fluticasone (Seretide) plus a short-acting beta(2)-agonist (SABA). METHODS: Patients (N=2309) with symptomatic asthma (aged 12 years; forced expiratory volume in 1s 50% predicted), who had experienced an asthma exacerbation in the previous year, were randomised to receive budesonide/formoterol 160/4.5 microg two inhalations twice daily and as needed, or one inhalation of salmeterol/fluticasone 50/500 microg twice daily plus terbutaline as needed, for 6 months. RESULTS: Time to first severe exacerbation, the pre-specified primary outcome, was not significantly prolonged (risk ratio 0.82; 95% confidence interval 0.63, 1.05). Budesonide/formoterol maintenance and reliever therapy reduced total exacerbations from 31 to 25 events/100 patients/year (P=0.039), and exacerbations requiring hospitalisation/emergency room (ER) treatment from 13 to 9 events/100 patients/year (P=0.046). The treatments showed no difference in measures of lung function or asthma symptoms. The mean dose of ICS received was lower using budesonide/formoterol maintenance and reliever therapy (792 microg/day budesonide [1238 microg/day beclomethasone dipropionate (BDP) equivalent] versus 1000 microg/day fluticasone [2000 microg/day BDP equivalent] with salmeterol/fluticasone therapy; P<0.0001). Both treatments were well tolerated. CONCLUSION: In the treatment of uncontrolled asthma, budesonide/formoterol maintenance and reliever therapy reduces the incidence of severe asthma exacerbations and hospitalisation/ER treatment with similar daily symptom control compared with sustained high-dose salmeterol/fluticasone plus SABA. This benefit is achieved with substantially less ICS exposure. |
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Authors:
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Jean Bousquet; Louis-Philippe Boulet; Matthew J Peters; Helgo Magnussen; Joaquin Quiralte; Nora E Martinez-Aguilar; Asa Carlsheimer |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2007-10-01 |
Journal Detail:
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Title: Respiratory medicine Volume: 101 ISSN: 0954-6111 ISO Abbreviation: Respir Med Publication Date: 2007 Dec |
Date Detail:
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Created Date: 2007-10-30 Completed Date: 2008-02-29 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: 2437-46 Citation Subset: IM |
Affiliation:
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Hôpital Arnaud de Villeneuve, 371 Avenue Doyen Gaston Giraud, FR-34000 Montpellier, France. jean.bousquet@orange.fr |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00242775 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Inhalation Adolescent Adrenergic beta-Agonists / therapeutic use Adult Aged Aged, 80 and over Albuterol / analogs & derivatives*, therapeutic use Androstadienes / therapeutic use* Anti-Asthmatic Agents / therapeutic use* Asthma / drug therapy*, physiopathology Azides / therapeutic use Budesonide / therapeutic use* Child Chronic Disease Double-Blind Method Drug Administration Schedule Drug Combinations Drug Therapy, Combination Ethanolamines / therapeutic use* Female Hospitalization Humans Lung / physiopathology Male Middle Aged Proportional Hazards Models Respiratory Function Tests Serotonin / analogs & derivatives, therapeutic use Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Adrenergic beta-Agonists; 0/Androstadienes; 0/Anti-Asthmatic Agents; 0/Azides; 0/Drug Combinations; 0/Ethanolamines; 0/fluticasone, salmeterol drug combination; 18559-94-9/Albuterol; 50-67-9/Serotonin; 51333-22-3/Budesonide; 5ZZ84GCW8B/formoterol; 98409-42-8/3-(2-(4-azidobenzamidino)ethyl)-5-hydroxyindole |
| Comments/Corrections | |
Erratum In:
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Respir Med. 2008 Jun;102(6):937-8 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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