Multicenter, double-blind, placebo-controlled trial of terfenadine in seasonal allergic rhinitis and conjunctivitis. 1985

J P Kemp, and C E Buckley, and M E Gershwin, and E Buchman, and F L Cascio, and J H Chretien, and T S Foster, and W E Gordon, and C Jakle, and S J Klemawesch

A multiclinic, double-blind, parallel and controlled study was conducted in the 1982 spring pollen season to evaluate and compare the effects of terfenadine, 60 mg bid with those of chlorpheniramine 4 mg tid and placebo for a treatment period of seven days in patients with seasonal allergic rhinitis and conjunctivitis. Of a total of 397 patients enrolled in the seven study centers, 345 patients were accepted for evaluation of efficacy and 393 patients for safety. The results show that based on the physicians' assessment of the overall efficacy, terfenadine was significantly superior to placebo and comparable to chlorpheniramine in the relief of allergic symptoms, with moderate to complete relief being observed in 60% (68/113) of the terfenadine-treated patients, in 60% (71/119) of the chlorpheniramine-treated patients, and in 30% (34/119) of the placebo-treated patients. The daily evaluation of severity of symptoms by the patients show that the effect of terfenadine and chlorpheniramine was evident on the first day after entry, reached a peak on the second day after entry, and persisted thereafter. Side effects were minor and infrequent in all treatment groups. There was no statistically significant difference in the incidence of sedation between the terfenadine (7.6%) and placebo (2.4%) groups whereas the incidence of sedation with chlorpheniramine (19%) was significantly higher. In conclusion, terfenadine is as effective as chlorpheniramine in the treatment of symptoms of seasonal allergic rhinitis and conjunctivitis with an incidence of sedation not significantly different from that with placebo and significantly less than with chlorpheniramine.

UI MeSH Term Description Entries
D008297 Male Males
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D003231 Conjunctivitis INFLAMMATION of the CONJUNCTIVA. Pink Eye,Conjunctivitides,Pink Eyes
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D006255 Rhinitis, Allergic, Seasonal Allergic rhinitis that occurs at the same time every year. It is characterized by acute CONJUNCTIVITIS with lacrimation and ITCHING, and regarded as an allergic condition triggered by specific ALLERGENS. Hay Fever,Pollen Allergy,Pollinosis,Seasonal Allergic Rhinitis,Hayfever,Allergic Rhinitides, Seasonal,Allergic Rhinitis, Seasonal,Allergies, Pollen,Allergy, Pollen,Fever, Hay,Pollen Allergies,Pollinoses,Rhinitides, Seasonal Allergic,Rhinitis, Seasonal Allergic,Seasonal Allergic Rhinitides
D006634 Histamine H1 Antagonists Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. Antihistamines, Classical,Antihistaminics, Classical,Antihistaminics, H1,Histamine H1 Antagonist,Histamine H1 Receptor Antagonist,Histamine H1 Receptor Antagonists,Histamine H1 Receptor Blockaders,Antagonists, Histamine H1,Antagonists, Histamine H1 Receptor,Antihistamines, Sedating,Blockaders, Histamine H1 Receptor,First Generation H1 Antagonists,H1 Receptor Blockaders,Histamine H1 Blockers,Receptor Blockaders, H1,Antagonist, Histamine H1,Classical Antihistamines,Classical Antihistaminics,H1 Antagonist, Histamine,H1 Antagonists, Histamine,H1 Antihistaminics,Sedating Antihistamines
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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