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Loratadine-pseudoephedrine in children with allergic rhinitis, a controlled double-blind trial
H A Serra1, O Alves, L F Rizzo
1Pharmacological Department, School of Medicine, University of Buenos Aires, Argentina.
Insights
Loratadine-pseudoephedrine combination effectively treats children's seasonal allergic rhinitis symptoms and signs. This combination medication was well-tolerated, with minimal side effects observed in the study.
Area of Science:
- Pediatric Allergy and Immunology
- Pharmacology and Therapeutics
Background:
- Seasonal allergic rhinitis (SAR) significantly impacts children's quality of life.
- Effective and safe treatment options for pediatric SAR are crucial.
Purpose of the Study:
- To evaluate the efficacy and tolerability of a loratadine-pseudoephedrine combination (L+PS) in children with SAR.
- To compare the effects of L+PS against a placebo in a pediatric population.
Main Methods:
- A randomized, double-blind, placebo-controlled, crossover trial involving 40 children (aged 3-15 years).
- Participants received L+PS or placebo for 14 days, followed by a 7-day washout period and then the alternative treatment.
- Efficacy was measured using the mean total symptom score (MTSS) and specific nasal symptom and sign assessments.
Main Results:
- L+PS demonstrated a significant reduction in MTSS (-4.29, 27.8% change) compared to placebo (-1.63, 10.7% change) (P < 0.001).
- L+PS significantly improved both nasal symptoms and signs, while placebo primarily affected symptoms.
- The combination was well-tolerated, with only one instance of transient insomnia reported.
Conclusions:
- Loratadine-pseudoephedrine combination is a useful and well-tolerated treatment for children with seasonal allergic rhinitis.
- The study highlights the importance of considering placebo effects in the design of future clinical trials for pediatric allergic rhinitis.
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.
Methods:
Forty 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.
Conclusions:
It 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.