Montelukast added to fluticasone propionate does not alter inflammation or outcomes.
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.
Djukanović
Ratko
R
University of Southampton, Southampton, UK. rd1@soton.ac.uk
Wilson
Susan J
SJ
Moore
Wendy C
WC
Koenig
Steven M
SM
Laviolette
Michel
M
Bleecker
Eugene R
ER
Davis
W Bruce
WB
Doherty
Dennis E
DE
Olivenstein
Ronald
R
Israel
Elliott
E
Kavuru
Mani S
MS
Kleerup
Eric
E
Reilly
Donna S
DS
Yancey
Steven W
SW
Edwards
Lisa D
LD
Stauffer
John L
JL
Dorinsky
Paul M
PM
Jarjour
Nizar N
NN
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
D000085:Acetates; D000730:Androstadienes; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; D000068298:Fluticasone; C093875:montelukast