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Loratadine‐pseudoephedrine in children with allergic rhinitis, a controlled double‐blind trial
Author(s) -
Serra Héctor Alejandro,
Alves Oscar,
Rizzo Leonardo Francisco Luis,
Devoto Flavio Marcelo,
Ascierto Héctor
Publication year - 1998
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1046/j.1365-2125.1998.00657.x
Subject(s) - loratadine , medicine , pseudoephedrine , placebo , nasal congestion , itching , randomized controlled trial , anesthesia , allergy , adverse effect , crossover study , surgery , nose , alternative medicine , pathology , ephedrine , immunology
Aims To conduct a randomized placebo controlled double‐blind crossover trial in order to evaluate a loratadine‐pseudoephedrine combination (L+PS) in children with seasonal allergic rhinitis.MethodsForty children (15 males; 25 females), aged 3–15 years, were included in this study. They were randomized to receive L+PS (0.2 mg kg −1 body weight–2.4 mg kg −1 body weight respectively) or placebo (PLA) for 14 days. After 7 days of washout, patients were shifted to the other treatment for a further 14 days. Nasal symptoms (sneezing/itching, congestion, nasal dripping) and signs (turbinal swelling, retronasal drainage), rated on a scale ranging from: 1. absent to 5. very intense, and their sum or mean total symptom score (MTSS) were used as efficacy measurement.Results Significant relief was observed; post‐treatment MTSS difference and its percent change were respectively; L+PS=−4.29; 95% CI: −3.64 and −4.94 (27.8%), and PLA=−1.63; 95% CI: −0.95 and −2.31 (10.7%) ( P <0.001 baseline vs endpoint and between treatments). Furthermore, L+PS and PLA significantly modified symptoms, but only L+PS significantly modified signs. No clinical changes were observed during the trial; only one patient showed slight transient insomnia when receiving L+PS.ConclusionsIt is concluded that L+PS is useful and well tolerated in children with seasonal allergic rhinitis. However, elements such as placebo effect must be taken into account for planning future trials.