BACKGROUND: The effects of single or combined histamine H(1)-receptor and leukotriene CysLT(1)-receptor antagonism on nasal adenosine monophosphate (AMP) challenge in allergic rhinitis are unknown. OBJECTIVE: We elected to study the effects of usual clinically recommended doses of fexofenadine (FEX), montelukast (ML) and FEX + ML combination, compared with placebo (PL), on nasal AMP challenge in patients with persistent allergic rhinitis. METHODS:Twelve patients with persistent allergic rhinitis (all skin prickpositive to house dust mite) were randomized in a double-blind cross-over fashion to receive for 1 week either FEX 180 mg, ML 10 mg, FEX 180 mg + ML 10 mg combination, or PL, with nasal AMP challenge performed 12 h after dosing. There was a 1-week washout period between each randomized treatment. The primary outcome measure was the maximum percentage peak nasal inspiratory flow (PNIF) fall from baseline over a 60-min period after nasal challenge with a single 400 mg ml(-1) dose of AMP. The area under the 60-min time-response curve (AUC) and nasal symptoms were measured as secondary outcomes. RESULTS: There was significant attenuation (P < 0.05) of the mean maximum percentage PNIF fall from baseline after nasal AMP challenge vs. PL, 48; with FEX, 37; 95% confidence interval for difference 2, 20; ML, 35 (4, 22); and FEX + ML, 32 (7, 24). The AUC (%.min) was also significantly attenuated (P < 0.05) vs. PL, 1893; with FEX, 1306 (30, 1143); ML, 1246 (214, 1078); and FEX + ML, 1153 (251, 1227). There were no significant differences for FEX vs. ML vs. FEX + ML comparing either the maximum or AUC response. The total nasal symptom score (out of 12) was also significantly improved (P < 0.05) vs. PL, 3.3; with FEX, 2.1 (0.3, 2.0); ML, 2.0 (0.5, 1.9); and FEX + ML, 2.5 (0.1, 1.4). CONCLUSION:FEX and ML as monotherapy significantly attenuated the response to nasal AMP challenge and improved nasal symptoms compared with PL, while combination therapy conferred no additional benefit.
RCT Entities:
BACKGROUND: The effects of single or combined histamine H(1)-receptor and leukotriene CysLT(1)-receptor antagonism on nasal adenosine monophosphate (AMP) challenge in allergic rhinitis are unknown. OBJECTIVE: We elected to study the effects of usual clinically recommended doses of fexofenadine (FEX), montelukast (ML) and FEX + ML combination, compared with placebo (PL), on nasal AMP challenge in patients with persistent allergic rhinitis. METHODS: Twelve patients with persistent allergic rhinitis (all skin prick positive to house dust mite) were randomized in a double-blind cross-over fashion to receive for 1 week either FEX 180 mg, ML 10 mg, FEX 180 mg + ML 10 mg combination, or PL, with nasal AMP challenge performed 12 h after dosing. There was a 1-week washout period between each randomized treatment. The primary outcome measure was the maximum percentage peak nasal inspiratory flow (PNIF) fall from baseline over a 60-min period after nasal challenge with a single 400 mg ml(-1) dose of AMP. The area under the 60-min time-response curve (AUC) and nasal symptoms were measured as secondary outcomes. RESULTS: There was significant attenuation (P < 0.05) of the mean maximum percentage PNIF fall from baseline after nasal AMP challenge vs. PL, 48; with FEX, 37; 95% confidence interval for difference 2, 20; ML, 35 (4, 22); and FEX + ML, 32 (7, 24). The AUC (%.min) was also significantly attenuated (P < 0.05) vs. PL, 1893; with FEX, 1306 (30, 1143); ML, 1246 (214, 1078); and FEX + ML, 1153 (251, 1227). There were no significant differences for FEX vs. ML vs. FEX + ML comparing either the maximum or AUC response. The total nasal symptom score (out of 12) was also significantly improved (P < 0.05) vs. PL, 3.3; with FEX, 2.1 (0.3, 2.0); ML, 2.0 (0.5, 1.9); and FEX + ML, 2.5 (0.1, 1.4). CONCLUSION:FEX and ML as monotherapy significantly attenuated the response to nasal AMP challenge and improved nasal symptoms compared with PL, while combination therapy conferred no additional benefit.
Authors: M Van Den Berge; R J Meijer; H A Kerstjens; D M de Reus; G H Koëter; H F Kauffman; D S Postma Journal: Am J Respir Crit Care Med Date: 2001-06 Impact factor: 21.405
Authors: A M Wilson; E J Sims; L C Orr; W J Coutie; P S White; Q Gardiner; B J Lipworth Journal: Ann Allergy Asthma Immunol Date: 2001-10 Impact factor: 6.347
Authors: H Koskela; M B Di Sciascio; S D Anderson; M Andersson; H K Chan; S Gadalla; C Katelaris Journal: Clin Exp Allergy Date: 2000-11 Impact factor: 5.018
Authors: M van den Berge; H A Kerstjens; R J Meijer; D M de Reus; G H Koëter; H F Kauffman; D S Postma Journal: Am J Respir Crit Care Med Date: 2001-10-01 Impact factor: 21.405