Loratadine-pseudoephedrine combination versus placebo in patients with seasonal allergic rhinitis.
Two hundred sixty-four patients with moderate to severe seasonal allergic rhinitis were treated with loratadine 5 mg plus pseudoephedrine 120 mg twice a day or placebo in a 28-day multicenter study. Four nasal and four non-nasal symptoms were evaluated for efficacy. At the last evaluable visit, the active treatment group had significantly lower (P = .05) mean combined nasal and non-nasal symptom scores than the placebo group. Also, the physician's rating of overall therapeutic response was significantly better in the active-treatment group (P = .03). Dry mouth, insomnia, and nervousness were reported by a significantly greater proportion (P less than or equal to .04) in the active-treatment group. Sedation occurred in 7% of patients in each treatment group and 6% of patients in each group discontinued the study because of adverse experiences. Loratadine plus pseudoephedrine was safe and significantly more effective than placebo in relieving the symptoms of allergic rhinitis.
Grossman
J
J
Allergy Division, Albany Medical College, New York.
Bronsky
E A
EA
Lanier
B Q
BQ
Linzmayer
M I
MI
Moss
B A
BA
Schenkel
E J
EJ
Selner
J C
JC
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D003533:Cyproheptadine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004338:Drug Combinations; D004809:Ephedrine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006633:Histamine Antagonists / Q000627:therapeutic use*; D006801:Humans; D017336:Loratadine; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*
D004338:Drug Combinations; D006633:Histamine Antagonists; D010919:Placebos; D003533:Cyproheptadine; D017336:Loratadine; D004809:Ephedrine