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Montelukast and fluticasone compared with salmeterol and fluticasone in protecting against asthma exacerbation in adults: one year, double blind, randomised, comparative trial

Bjermer, Leif LU ; Bisgaard, H; Bousquet, J; Fabbri, LM; Greening, AP; Haahtela, T; Holgate, ST; Picado, C; Menten, J and Dass, SB, et al. (2003) In B M J: British Medical Journal1995-01-01+01:00 327(7420). p.891-895
Abstract
Objectives To assess the effect of montelukast versus salmeterol added to inhaled fluticasone propionate on asthma exacerbation in patients whose symptoms are inadequately controlled with fluticasone alone. Design and setting A 52 week, two period, double blind, multicentre trial during which patients whose symptoms remained uncontrolled by inhaled corticosteroids were randomised to add montelukast or salmeterol. Participants Patients (15-72 years; n = 1490) had a clinical history of chronic asthma for greater than or equal to1 year, a baseline forced expiratory volume in one second (FEV1) value 50-90% predicted, and a beta agonist improvement of greater than or equal to 12% in FEV1. Main outcome measures The primary end point was the... (More)
Objectives To assess the effect of montelukast versus salmeterol added to inhaled fluticasone propionate on asthma exacerbation in patients whose symptoms are inadequately controlled with fluticasone alone. Design and setting A 52 week, two period, double blind, multicentre trial during which patients whose symptoms remained uncontrolled by inhaled corticosteroids were randomised to add montelukast or salmeterol. Participants Patients (15-72 years; n = 1490) had a clinical history of chronic asthma for greater than or equal to1 year, a baseline forced expiratory volume in one second (FEV1) value 50-90% predicted, and a beta agonist improvement of greater than or equal to 12% in FEV1. Main outcome measures The primary end point was the percentage of patients with at least one asthma exacerbation. Results 20.1% of the patients in the group receiving montelukast and fluticasone had an asthma exacerbation compared with 19.1% in the group receiving salmeterol and fluticasone; the difference was 1% (95% confidence interval - 3.1% to 5.0%). With a risk ratio (montelukast-fluticasone/ salmeterol-fluticasone) of 1.05 (0.86 to 1.29), treatment with montelukast and fluticasone was shown to be non-inferior to treatment with salmeterol and fluticasone. Salmeterol and fluticasonc significantly increased FEV1 before a beta agonist was used and morning peak expiratory flow compared with montelukast and fluticasone (P less than or equal to0.001), whereas FEV1 after a beta agonist was used and improvements in asthma specific quality of life and nocturnal awakenings were similar between the groups. Montelukast and fluticasone significantly (P = 0.011) reduced peripheral blood eosinophil counts compared with salmeterol and fluticasone. Both treatments were generally well tolerated. Conclusion The addition of montelukast in patients whose symptoms remain uncontrolled by inhaled fluticasone could provide equivalent clinical control to salmeterol. (Less)
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B M J: British Medical Journal1995-01-01+01:00
volume
327
issue
7420
pages
891 - 895
publisher
BMJ Publishing Group
external identifiers
  • pmid:14563743
  • wos:000186072100015
  • scopus:0142074290
ISSN
1756-1833
DOI
10.1136/bmj.327.7420.891
language
English
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yes
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b6ddf8db-a6f6-4f1a-815f-207470930d96 (old id 298471)
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http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=14563743&dopt=Abstract
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2007-08-24 10:49:25
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2018-02-18 03:42:07
@article{b6ddf8db-a6f6-4f1a-815f-207470930d96,
  abstract     = {Objectives To assess the effect of montelukast versus salmeterol added to inhaled fluticasone propionate on asthma exacerbation in patients whose symptoms are inadequately controlled with fluticasone alone. Design and setting A 52 week, two period, double blind, multicentre trial during which patients whose symptoms remained uncontrolled by inhaled corticosteroids were randomised to add montelukast or salmeterol. Participants Patients (15-72 years; n = 1490) had a clinical history of chronic asthma for greater than or equal to1 year, a baseline forced expiratory volume in one second (FEV1) value 50-90% predicted, and a beta agonist improvement of greater than or equal to 12% in FEV1. Main outcome measures The primary end point was the percentage of patients with at least one asthma exacerbation. Results 20.1% of the patients in the group receiving montelukast and fluticasone had an asthma exacerbation compared with 19.1% in the group receiving salmeterol and fluticasone; the difference was 1% (95% confidence interval - 3.1% to 5.0%). With a risk ratio (montelukast-fluticasone/ salmeterol-fluticasone) of 1.05 (0.86 to 1.29), treatment with montelukast and fluticasone was shown to be non-inferior to treatment with salmeterol and fluticasone. Salmeterol and fluticasonc significantly increased FEV1 before a beta agonist was used and morning peak expiratory flow compared with montelukast and fluticasone (P less than or equal to0.001), whereas FEV1 after a beta agonist was used and improvements in asthma specific quality of life and nocturnal awakenings were similar between the groups. Montelukast and fluticasone significantly (P = 0.011) reduced peripheral blood eosinophil counts compared with salmeterol and fluticasone. Both treatments were generally well tolerated. Conclusion The addition of montelukast in patients whose symptoms remain uncontrolled by inhaled fluticasone could provide equivalent clinical control to salmeterol.},
  author       = {Bjermer, Leif and Bisgaard, H and Bousquet, J and Fabbri, LM and Greening, AP and Haahtela, T and Holgate, ST and Picado, C and Menten, J and Dass, SB and Leff, JA and Polos, PG},
  issn         = {1756-1833},
  language     = {eng},
  number       = {7420},
  pages        = {891--895},
  publisher    = {BMJ Publishing Group},
  series       = {B M J: British Medical Journal1995-01-01+01:00},
  title        = {Montelukast and fluticasone compared with salmeterol and fluticasone in protecting against asthma exacerbation in adults: one year, double blind, randomised, comparative trial},
  url          = {http://dx.doi.org/10.1136/bmj.327.7420.891},
  volume       = {327},
  year         = {2003},
}