A comparison of once daily fexofenadine versus the combination of montelukast plus loratadine on domiciliary nasal peak flow and symptoms in seasonal allergic rhinitis.
BACKGROUND
The combination of montelukast (ML) and loratadine (LT) has previously been shown to be superior to either drug alone in managing seasonal allergic rhinitis (SAR), whilst fexofenadine (FEX) has been shown to be better than LT as monotherapy.


OBJECTIVE
We wished to compare ML + LT vs. FEX alone for effects on daily measurements (am/pm) of peak inspiratory flow (PIF) and symptoms.


METHODS
Thirty-seven patients with SAR (skin prick positive to grass pollen) were randomised into a single-blind, double-dummy placebo (PL)-controlled cross-over study during the grass pollen season, comparing 2 weeks of once daily treatment with (a) 120mg FEX or (b) 10mg ML + 10mg LT. There was a 7-10 day placebo run-in and washout prior to each randomised treatment. The average of am/pm PIF (the primary outcome variable) was analysed. Patients recorded their symptom scores (from 0 to 3) twice daily, for nasal blockage, discharge, itching and sneezing with; total eye symptoms, ocular cromoglycate use, and daily activity. The total nasal symptom score was calculated as a composite (out of 24).


RESULTS
There were no significant differences between baselines after the run-in and washout placebos for any variables. There were significant (P < 0.05, Bonferroni) improvements in all symptoms and PIF compared to pooled placebo with both treatments for all end-points, but no differences between the two treatment regimes (as means and within-treatment 95% confidence intervals): PIF: PL 102 (98-107), FEX 111 (107-116), ML+LT 113 (109-118); total nasal symptoms: PL 7.4 (6.7-2.0), FEX 5.0 (4.3-5.7), ML + LT 4.0 (3.3-4.7).


CONCLUSIONS
Once daily FEX as monotherapy was equally effective as the combination of once daily ML + LT in improving nasal peak flow and controlling symptoms in SAR. Further studies are indicated to assess whether ML confers additional benefits to FEX in SAR.
Wilson
A M
AM
Asthma & Allergy Research Group, Department of Clinical Pharmacology & Therapeutics, Ninewells Hospital & Medical School, University of Dundee, Scotland, UK.
Orr
L C
LC
Coutie
W J R
WJ
Sims
E J
EJ
Lipworth
B J
BJ
D000085:Acetates / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D018592:Cross-Over Studies; D003521:Cyclopropanes; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006801:Humans; D020024:Leukotriene Antagonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D017336:Loratadine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D009296:Nasal Cavity / Q000503:physiopathology*; D006109:Poaceae / Q000276:immunology; D011058:Pollen / Q000276:immunology; D012123:Pulmonary Ventilation / Q000187:drug effects*; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology; D016037:Single-Blind Method; D012882:Skin Tests; D013440:Sulfides; D016593:Terfenadine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000085:Acetates; D018926:Anti-Allergic Agents; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; D017336:Loratadine; D016593:Terfenadine; C093230:fexofenadine; C093875:montelukast