A multicentre study of loratadine, clemastine and placebo in patients with perennial allergic rhinitis.
This multicentre, double-blind, randomized parallel-group study compared 3 weeks' treatment with either loratadine (Clarityn) 10 mg once daily, or clemastine (Tavegyl) 1 mg twice daily, and placebo in outpatients with active perennial allergic rhinitis. 155 patients were evaluated for efficacy and safety. Grading of four nasal and three non-nasal symptoms, rhinoscopy signs, and therapeutic response was performed on treatment days 6, 13, and 20. Patients recorded daily symptoms and possible adverse experiences in a diary, also indicating when symptoms of active rhinitis were relieved. Loratadine and clemastine were statistically significantly superior to placebo throughout the study (P less than 0.05), based on assessment of patients' nasal and eye symptoms, patients' diary scores, rhinoscopy signs of symptoms, and onset of relief. The loratadine group showed a statistically significantly (P less than 0.05) faster onset of relief of symptoms compared with the group treated with clemastine. Concerning nasal stuffiness, loratadine was significantly (P less than 0.05) superior to clemastine after 1 week's treatment. Reports of adverse reactions showed that significantly (P less than 0.05) more patients complained of sedation in the clemastine than in the loratadine group. Regarding other adverse experiences and laboratory tests, the three treatment groups were statistically comparable (P less than 0.05). The study showed that compared with placebo both loratadine and clemastine were effective in relieving nasal and eye symptoms in patients with perennial allergic rhinitis. Loratadine was safe and well tolerated and was significantly less sedative than clemastine; loratadine may therefore possess an advantage in clinical use in the treatment of perennial allergic rhinitis.
Frølund
L
L
State University Hospital, Copenhagen, Denmark.
Etholm
B
B
Irander
K
K
Johannessen
T A
TA
Odkvist
L
L
Ohlander
B
B
Weeke
B
B
D000293:Adolescent; D000328:Adult; D000368:Aged; D002974:Clemastine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003533:Cyproheptadine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006633:Histamine Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D017336:Loratadine; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011759:Pyrrolidines / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*; D013997:Time Factors
D006633:Histamine Antagonists; D011759:Pyrrolidines; D003533:Cyproheptadine; D017336:Loratadine; D002974:Clemastine