title: Montelukast added to fluticasone propionate does not alter inflammation or outcomes.
abstract: BACKGROUND
  Airway inflammation is a key pathological feature of asthma which underlies its clinical presentation.
  
  
  OBJECTIVE
  To examine whether adding a leukotriene modifier to an inhaled corticosteroid produces further clinical and/or anti-inflammatory benefits in patients symptomatic on short-acting beta(2)-agonists.
  
  
  METHODS
  Patients uncontrolled on short-acting beta(2)-agonists were treated for 12 weeks with either fluticasone propionate (100mcg BD) or fluticasone propionate (100mcg BD) and montelukast (10mg QD) in a randomized, double-blind, parallel group study. Bronchoscopy with endobronchial biopsy and bronchoalveolar lavage (BAL) was performed before and after treatment to compare effects on airway inflammation.
  
  
  RESULTS
  Of 103 subjects enrolled, 89 subjects completed treatment and 82 subjects had matched pair biopsy samples. Submucosal eosinophil counts, the primary endpoint, and asthma control improved to similar extents after both treatments (p<or=0.008). Both treatments significantly reduced submucosal mast cell, CD3+, CD4+, CD8+ and CD25+ cell counts. Submucosal mast cell reduction was greater in the fluticasone propionate plus montelukast group. There were no differences between treatments in BAL markers of inflammation or thickness of sub-epithelial collagen.
  
  
  CONCLUSIONS
  Low-dose fluticasone propionate significantly improves clinical disease control and reduces airway inflammation in asthma patients uncontrolled with short-acting beta(2)-agonists without further improvement when montelukast is added to low-dose fluticasone propionate.
authors: University of Southampton, Southampton, UK. rd1@soton.ac.uk
authors: Ratko
authors: R
authors: Djukanović
authors: Susan J
authors: SJ
authors: Wilson
authors: Wendy C
authors: WC
authors: Moore
authors: Steven M
authors: SM
authors: Koenig
authors: Michel
authors: M
authors: Laviolette
authors: Eugene R
authors: ER
authors: Bleecker
authors: W Bruce
authors: WB
authors: Davis
authors: Dennis E
authors: DE
authors: Doherty
authors: Ronald
authors: R
authors: Olivenstein
authors: Elliott
authors: E
authors: Israel
authors: Mani S
authors: MS
authors: Kavuru
authors: Eric
authors: E
authors: Kleerup
authors: Donna S
authors: DS
authors: Reilly
authors: Steven W
authors: SW
authors: Yancey
authors: Lisa D
authors: LD
authors: Edwards
authors: John L
authors: JL
authors: Stauffer
authors: Paul M
authors: PM
authors: Dorinsky
authors: Nizar N
authors: NN
authors: Jarjour
mesh_terms: D000085:Acetates / Q000008:administration & dosage*; D000280:Administration, Inhalation; D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy* / Q000473:pathology; D001980:Bronchi / Q000187:drug effects* / Q000473:pathology; D003521:Cyclopropanes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004802:Eosinophilia / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume / Q000187:drug effects / Q000502:physiology; D006801:Humans; D008297:Male; D011804:Quinolines / Q000008:administration & dosage*; D013440:Sulfides; D016896:Treatment Outcome
chemical_list: D000085:Acetates; D000730:Androstadienes; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D000068298:Fluticasone; C093875:montelukast