Effect of the addition of montelukast to fluticasone propionate for the treatment of perennial allergic rhinitis.
BACKGROUND
Guidelines for the treatment of patients with allergic rhinitis (AR) recommend intranasal corticosteroids as first-line therapy. In clinical trials, however, only 50% of patients obtain excellent symptom control.


OBJECTIVE
To evaluate the effectiveness of montelukast add-on therapy in patients with perennial AR (PAR) who have incomplete relief of symptoms after 2 weeks of treatment with intranasal fluticasone propionate.


METHODS
We performed a 4-week parallel, randomized, double-blind, placebo-controlled trial. One hundred two patients with a history of PAR and a positive skin test reaction to perennial allergens were recruited. They completed the Rhinitis Quality of Life Questionnaire (RQLQ) and were given intranasal fluticasone propionate, 200 microg daily. They were asked to complete symptom diary cards twice daily. After 2 weeks of treatment, patients with a mean total nasal symptom score of at least 4 during the past week (n = 54) were randomized to receive either montelukast (n = 28) or placebo (n = 26) in addition to the continued use of fluticasone propionate. At weeks 3 and 4, the RQLQ was completed again and symptom diary cards were collected.


RESULTS
Compared with baseline, there were significant improvements in almost all domains of the RQLQ while taking fluticasone propionate (P < .001). A similar trend was observed for nasal symptom scores. After randomization to receive montelukast or placebo, there were no significant differences in RQLQ measures or nasal symptom scores between the groups during the 2 weeks of combination therapy.


CONCLUSIONS
The addition of montelukast to an intranasal corticosteroid for the treatment of PAR with residual symptoms is no more effective than is placebo.
Esteitie
Rania
R
Section of Otolaryngology-Head and Neck Surgery, The University of Chicago Medical Center and Pritzker School of Medicine, The University of Chicago, Chicago, Illinois 60637, USA.
deTineo
Marcy
M
Naclerio
Robert M
RM
Baroody
Fuad M
FM
D000085:Acetates / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000730:Androstadienes / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D003521:Cyclopropanes; D005240:Feasibility Studies; D005260:Female; D000068298:Fluticasone; D006801:Humans; D020024:Leukotriene Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects; D012221:Rhinitis, Allergic, Perennial / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012882:Skin Tests; D013440:Sulfides; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000085:Acetates; D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; D000068298:Fluticasone; C093875:montelukast