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

Table 2.

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

Reference Randomized participants Geographic region* Multi center Agent Study design Primary endpoint Validated outcome measure? Significant difference of primary endpoint?
Creticos et al61 784 Northern America and Eastern Europe Yes Sublingual allergy immunotherapy tablet (MK-3641; Merck and Co, Inc., Whitehouse Station, NJ, USA) 52 weeks, four arms: l.5 μg;6 μg; 12 μg; or placebo Combined symptom and medication score No Yes(12 μg)
Nolte et al60 565 Northern America Yes Sublingual allergy immunotherapy tablet (MK-3641; Merck and Co, Inc.) 52 weeks, three arms: 6 μg; 12 μg; or placebo Combined symptom and medication score No Yes (6 μg and 12 μg)
Skoner et al58 115 Northern America Yes Sublingual liquid (standardized glycerinated short ragweed pollen allergenic extract; Greer Laboratories, Inc., Lenoir, NC, USA) 17 weeks, three arms: 4.8 μg; 48 μg; or placebo Symptom score No No
Bowen et al59 83 Northern America Yes Sublingual liquid (active product standardized ragweed allergen extract; Staloral; Stallergenes SA, Antony, France) Ragweed season, two arms: increasing doses or placebo Combined symptom and medication score No No
Mirone et al53 32 Southern Europe Yes Subcutaneous injection (ragweed pollen extract absorbed with aluminum hydroxide/phenolated saline solution; ALK-Abellò, Hørsholm, Denmark) 12 months, two arms: increasing doses or placebo Not specifically designated No Not applicable
André et al57 110 Western Europe Yes Sublingual liquid or tablet (standardized ragweed extract; Stallergenes SA) 7.5 months, two arms: increasing doses or placebo Not specifically designated No Not applicable

Note:

*

Geographical subregion as defined by the United Nations Organization.