Document Detail


Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone.
MedLine Citation:
PMID:  17905575     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Jean Bousquet; Louis-Philippe Boulet; Matthew J Peters; Helgo Magnussen; Joaquin Quiralte; Nora E Martinez-Aguilar; Asa Carlsheimer
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2007-10-01
Journal Detail:
Title:  Respiratory medicine     Volume:  101     ISSN:  0954-6111     ISO Abbreviation:  Respir Med     Publication Date:  2007 Dec 
Date Detail:
Created Date:  2007-10-30     Completed Date:  2008-02-29     Revised Date:  2013-06-11    
Medline Journal Info:
Nlm Unique ID:  8908438     Medline TA:  Respir Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  2437-46     Citation Subset:  IM    
Affiliation:
Hôpital Arnaud de Villeneuve, 371 Avenue Doyen Gaston Giraud, FR-34000 Montpellier, France. jean.bousquet@orange.fr
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00242775
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MeSH Terms
Descriptor/Qualifier:
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:
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:
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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