Comparative efficacy and safety of once-daily versus twice-daily loratadine-pseudoephedrine combinations versus placebo in seasonal allergic rhinitis.

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.

• Authors: H B Kaiser, C H Banov, R R Berkowitz, D I Bernstein, E A Bronsky, J W Georgitis, L M Mendelson, A R Rooklin, L J Sholler, W W Stricker, J E Harrison, M R Danzig, R R Lorber
• Journal: American journal of therapeutics (Am J Ther) Vol. 5 Issue 4 Pg. 245-51 (Jul 1998) ISSN: 1075-2765 [Print] United States
• PMID: 10099066 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Allergic Agents
• Delayed-Action Preparations
• Drug Combinations
• Tablets
• Vasoconstrictor Agents
• Loratadine
• Ephedrine

Topics

• Adolescent
• Adult
• Aged
• Analysis of Variance
• Anti-Allergic Agents (administration & dosage, adverse effects)
• Child
• Delayed-Action Preparations
• Double-Blind Method
• Drug Administration Schedule
• Drug Combinations
• Ephedrine (administration & dosage, adverse effects)
• Female
• Humans
• Loratadine (administration & dosage, adverse effects)
• Male
• Middle Aged
• Rhinitis, Allergic, Seasonal (drug therapy)
• Tablets
• Treatment Outcome
• United States
• Vasoconstrictor Agents (administration & dosage, adverse effects)