| Title | Comparative efficacy and safety of once-daily versus twice-daily loratadine-pseudoephedrine combinations versus placebo in seasonal allergic rhinitis. | | Author(s) | Kaiser HB, Banov CH, Berkowitz RR, Bernstein DI, Bronsky EA, Georgitis JW, Mendelson LM, Rooklin AR, Sholler LJ, Stricker WW, Harrison JE, Danzig MR, Lorber RR | | Institution | Allergy & Asthma Specialists, PA, Minneapolis, MN 55402, USA. | | Source | Am J Ther 1998 Jul; 5(4):245-51. | | MeSH | Adolescent
Adult
Aged
Analysis of Variance
Anti-Allergic Agents
Child
Comparative Study
Delayed-Action Preparations
Double-Blind Method
Drug Administration Schedule
Drug Combinations
Ephedrine
Female
Humans
Loratadine
Male
Middle Aged
Research Support, Non-U.S. Gov't
Rhinitis, Allergic, Seasonal
Tablets
Treatment Outcome
United States
Vasoconstrictor Agents
| | Abstract | The objective of this study was to compare the efficacy and safety of Claritin-D 24 Hour (once daily) with that of Claritin-D 12 Hour (twice daily) and placebo in the treatment of patients with seasonal allergic rhinitis (SAR). In this double-blind, placebo-controlled, multicenter study, 469 patients with moderate-to-severe SAR symptoms were treated for 2 weeks with one of the following: Claritin-D 24 Hour (a combination tablet formulation of loratadine 10 mg in the coating and pseudoephedrine sulfate 240 mg in an extended-release core), Claritin-D 12 Hour (a combination tablet formulation of loratadine 5 mg in the tablet coating and 120 mg pseudoephedrine sulfate, 60 mg in the coating and 60 mg in the core), or placebo. Claritin-D 24 Hour and Claritin-D 12 Hour were consistently superior to placebo (P < 0.01) in reducing total, nasal, and nonnasal symptom scores. Patients in the Claritin-D 24 Hour and Claritin-D 12 Hour groups also had significantly greater (P </= 0.05) relief of rhinorrhea and nasal stuffiness as compared with placebo. Insomnia was reported significantly more often (P < 0.01) in Claritin-D 12 Hour (15%) patients compared with Claritin-D 24 Hour (4%) and placebo (2%) patients. Dry mouth was reported significantly more often (P < 0.05) in Claritin-D 24 Hour (13%) and Claritin-D 12 Hour (13%) groups compared with placebo (4%). Claritin-D 24 Hour has efficacy comparable to Claritin-D 12 Hour in relieving allergic rhinitis symptoms while producing significantly less insomnia. | | Language | eng | | Pub Type(s) | Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
| | PubMed ID | 10099066 |
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