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. 2015 Feb 16;8:15–24. doi: 10.2147/JAA.S47789

Table 1.

Recent prospective, randomized, controlled, double-blind Phase III studies for the symptomatic treatment of seasonal allergic rhinitis caused by ragweed pollen

Reference Randomized participants Geographic region* Multicenter Agent Study design Primary endpoint Validated outcome measure? Significant difference of primary endpoint?
Kaiser et al51 299 Northern America Yes Topical fluticasone furoate 15 days (during local allergy season), two arms: 1 10 mg versus placebo Symptom score No Yes
Patel et al44 320 Northern America No Topical olopatadine 1 day (allergen challenge chamber), four arms: once at 0.2%; 0.4%; or 0.6% versus placebo Symptom score Environmental exposure chamber was validated against natural exposure45,46 Yes (0.6%)
Patel and Patel47 403 Northern America No Oral levocetirizine versus montelukast versus placebo 2 days (allergen challenge chamber), three arms: levocetirizine 5 mg once daily versus montelukast 10 mg once daily versus placebo Symptom score No Yes (levocetirizine)
Day et al50 379 Northern America Yes Oral loratadine and montelukast versus phenylephrine versus placebo 2 days (allergen challenge chamber), three arms: loratadine 10 mg and montelukast 10 mg once daily versus phenylephrine 10 mg once daily versus placebo Peak nasal flow No Yes (loratadine and montelukast)
Moinuddin et al48 72 Northern America No Oral fexofenadine and pseudoephedrine versus loratadine and montelukast 2 weeks (during local allergy season), two arms: fexofenadine 60 mg and pseudoephedrine 120 mg twice daily versus loratadine, 10 mg and montelukast, 10 mg once daily Not specifically designated Rhinoconjunctivitis Quality of Life Questionnaire45 Not applicable

Note:

*

Geographical subregion as defined by the United Nations Organization.