Addition of leukotriene antagonists to therapy in chronic persistent asthma: a randomised double-blind placebo-controlled trial

Citation
Ds. Robinson et al., Addition of leukotriene antagonists to therapy in chronic persistent asthma: a randomised double-blind placebo-controlled trial, LANCET, 357(9273), 2001, pp. 2007-2011
Citations number
21
Language
INGLESE
art.tipo
Article
Categorie Soggetti
General & Internal Medicine","Medical Research General Topics
Journal title
LANCET
ISSN journal
0140-6736 → ACNP
Volume
357
Issue
9273
Year of publication
2001
Pages
2007 - 2011
Database
ISI
SICI code
0140-6736(20010623)357:9273<2007:AOLATT>2.0.ZU;2-Y
Abstract
Background Controlled trials suggest that leukotriene receptor antagonists can improve lung function and reduce requirement for oral or inhaled cortic osteroids in patients with asthma. We aimed to assess whether montelukast, a leukotriene receptor antagonist. can improve symptoms or lung function in patients with chronic asthma with symptoms already taking corticosteroids. Methods We did a double-blind, placebo-controlled, crossover, randomised ad d-on study in which 100 patients with asthma and symptoms despite treatment with inhaled corticosteroids and additional therapy were given 10 mg monte lukast sodium for 14 days in an outpatient clinic setting. Outcome measures were symptoms and peak flow diaries. Findings 72 patients had diary data for analysis. Compared with placebo. ad dition of montelukast did not result in any significant change in symptom s cores (mean difference between the last 7 days of each treatment period 0.0 5: 95% CI -0.86 to 1.14), rescue inhaled beta (2) agonist use (mean differe nce in puffs per day 0.41; -0.29 to 0.57), or twice daily peak expiratory f low (PEF) measurements (mean difference in morning PEF 1.18 L/min; -14.29 t o 17.14). and mean difference in evening peak flow (-0.50; -17.42 to 12.86) . When treatment response was defined as a 15% or greater increase in mean peak flow readings, there were four responders to montelukast and seven res ponders to placebo. Interpretation Based on PEF data from our previous studies of a similar pat ient group we would have expected to detect changes of more than 5%. Used a s additional therapy in a hospital outpatient clinic setting, montelukast d id not provide such additional benefit in patients with moderate or severe asthma.