Related Experiment Video
Updated: Feb 5, 2026
Author Spotlight: Advancing Allergic Rhinitis Research with Multicolor Immunofluorescence
Published on: September 22, 2023
Rupatadine oral solution for 2-5-year-old children with allergic rhinitis: a safety, open-label, prospective study
Eva Santamaría1,2, Iñaki Izquierdo2, Marta Valle1,3
1Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain, MValleC@santpau.cat.
Insights
This study found rupatadine oral solution safe and effective for treating allergic rhinitis (AR) in children aged 2-5 years. Daily administration significantly reduced AR symptoms, demonstrating its potential for this young pediatric group.
Area of Science:
- Pediatric Allergy and Immunology
- Clinical Pharmacology
- Drug Safety in Pediatrics
Background:
- Limited clinical trials exist for antihistamine efficacy in very young children.
- Rupatadine, a second-generation antihistamine, is approved for allergic rhinitis (AR) and urticaria.
- This study focuses on AR symptom evaluation in children aged 2-5 years.
Purpose of the Study:
- To assess the efficacy and safety of rupatadine oral solution in treating allergic rhinitis (AR) in children aged 2-5 years.
- To evaluate the impact of daily rupatadine administration on AR symptom scores in this pediatric population.
Main Methods:
- A multicenter, open-label study involving 44 children aged 2-5 years with AR.
- Rupatadine oral solution (1 mg/mL) was administered daily, with dosage based on body weight.
- Safety assessments included adverse events and QTc interval; efficacy was measured by the Total Five Symptoms Score (T5SS) before and after 4 weeks of treatment.
Main Results:
- A total of 44 children received treatment, with 15 mild adverse events reported, none considered treatment-related.
- No significant QTc interval prolongation was observed.
- The Total Five Symptoms Score (T5SS) significantly decreased from baseline (8.65) to Day 14 (6.35) and Day 28 (5.42), representing reductions of 26.6% and 37.4%, respectively (p<0.001).
- Individual AR symptoms, including nasal congestion, also showed significant improvement.
Conclusions:
- Rupatadine 1 mg/mL oral solution is safe for children aged 2-5 years.
- Daily administration of rupatadine effectively improves overall and individual allergic rhinitis symptoms in this age group.
- This study contributes valuable clinical evidence for rupatadine use in very young pediatric patients.
Background:
There are few clinical trials that assess the efficacy of antihistamines in very young children. Rupatadine is a second-generation antihistamine indicated for the treatment of allergic rhinitis (AR) and urticaria. In this study, AR symptoms were evaluated before and after daily 1 mg/mL rupatadine oral solution administration in 2-5-year-old children.
Methods:
A multicenter open-label study was carried out in 2-5-year-old children with AR. Safety assessments were collected during the study including spontaneous adverse events, vital signs, and electrocardiogram (QTc interval). Additionally, evaluations of Total Five Symptoms Score (T5SS, including: nasal congestion; sneezing; rhinorrhoea; itchy nose, mouth, throat, and/or ears; and itchy, watery, and red eyes) were analyzed. Symptoms were evaluated by parents/legal guardian before and after 4 weeks of rupatadine administration, dosed according to body weight.
Results:
A total of 44 children received the study treatment. Only 15 adverse events were reported. All of them were of mild intensity and considered not related to the study treatment. No patient exceeded the standard parameter of >450 ms in the last visit, for the QTc interval on their electrocardiograms. From a maximum score value of 15, T5SS values at Day 14 (6.35) and Day 28 (5.42) were both statistically significant different (p<0.001) from the baseline T5SS value (mean 8.65), with a reduction of 26.6% and 37.4%, respectively. All individual symptoms, including nasal congestion, showed also a decrease from baseline at both 14 and 28 days.
Conclusion:
Rupatadine 1 mg/mL oral solution was found to be safe in 2-5-year-old children, correlating with an improvement of AR symptoms, overall and each individually, after a daily dose administration. With this study, we enlarge the available information in this very young pediatric patients' group, in which there is a general lack of clinical evidence.
More Related Videos
Related Concept Videos
02:06Allergic Reactions
01:28Survey Safety
01:27Allergic Drug Reactions
01:045-Number Summary
In a box plot, the minimum and maximum data values represent the lower and upper whiskers in the graph, and the median is designated as the center of the box in the chart. The first quartile and third...
03:21Weak Base Solutions
02:59Solution Concentration and Dilution