title: Randomised controlled trial of montelukast plus inhaled budesonide versus double dose inhaled budesonide in adult patients with asthma.
abstract: BACKGROUND
  Inhaled corticosteroids (ICS) affect many inflammatory pathways in asthma but have little impact on cysteinyl leukotrienes. This may partly explain persistent airway inflammation during chronic ICS treatment and failure to achieve adequate asthma control in some patients. This double blind, randomised, parallel group, non-inferiority, multicentre 16 week study compared the clinical benefits of adding montelukast to budesonide with doubling the budesonide dose in adults with asthma.
  
  
  METHODS
  After a 1 month single blind run in period, patients inadequately controlled on inhaled budesonide (800 microg/day) were randomised to receive montelukast 10 mg + inhaled budesonide 800 microg/day (n=448) or budesonide 1600 microg/day (n=441) for 12 weeks.
  
  
  RESULTS
  Both groups showed progressive improvement in several measures of asthma control compared with baseline. Mean morning peak expiratory flow (AM PEF) improved similarly in the last 10 weeks of treatment compared with baseline in both the montelukast + budesonide group and in the double dose budesonide group (33.5 v 30.1 l/min). During days 1-3 after start of treatment, the change in AM PEF from baseline was significantly greater in the montelukast + budesonide group than in the double dose budesonide group (20.1 v 9.6 l/min, p<0.001), indicating faster onset of action in the montelukast group. Both groups showed similar improvements with respect to "as needed" beta agonist use, mean daytime symptom score, nocturnal awakenings, exacerbations, asthma free days, peripheral eosinophil counts, and asthma specific quality of life. Both montelukast + budesonide and double dose budesonide were generally well tolerated.
  
  
  CONCLUSIONS
  The addition of montelukast to inhaled budesonide is an effective and well tolerated alternative to doubling the dose of inhaled budesonide in adult asthma patients experiencing symptoms and inadequate control on budesonide alone.
authors.affiliation: Department of General Practice and Primary Care, University of Aberdeen, Foresterhill Health Centre, Westburn Road, Aberdeen AB25 2AY, Scotland, UK. d.price@abdn.ac.uk
authors.forename: D B
authors.initials: DB
authors.lastname: Price
authors.forename: D
authors.initials: D
authors.lastname: Hernandez
authors.forename: P
authors.initials: P
authors.lastname: Magyar
authors.forename: J
authors.initials: J
authors.lastname: Fiterman
authors.forename: K M
authors.initials: KM
authors.lastname: Beeh
authors.forename: I G
authors.initials: IG
authors.lastname: James
authors.forename: S
authors.initials: S
authors.lastname: Konstantopoulos
authors.forename: R
authors.initials: R
authors.lastname: Rojas
authors.forename: J A
authors.initials: JA
authors.lastname: van Noord
authors.forename: M
authors.initials: M
authors.lastname: Pons
authors.forename: L
authors.initials: L
authors.lastname: Gilles
authors.forename: J A
authors.initials: JA
authors.lastname: Leff
mesh_terms: D000085:Acetates / Q000008:administration & dosage*; D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D003521:Cyclopropanes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011804:Quinolines / Q000008:administration & dosage*; D016037:Single-Blind Method; D013440:Sulfides; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D018927:Anti-Asthmatic Agents; D001993:Bronchodilator Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D019819:Budesonide; C093875:montelukast