Rupatadine oral solution for 2-5-year-old children with allergic rhinitis: a safety, open-label, prospective study

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 or...

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Bibliographic Details
Published in:Journal of asthma and allergy 2018-01, Vol.11, p.225-231
Main Authors: Santamaría, Eva, Izquierdo, Iñaki, Valle, Marta, Vermeulen, Jan, Potter, Paul
Format: Article
Language:English
Subjects:
Allergic rhinitis
Allergies
Antihistamines
Asthma
Body weight
Care and treatment
Child health
Children
Ciclesonide
Clinical trials
Drug dosages
EKG
Electrocardiography
Histamine
Hives (Disease)
Medical research
Nose
Oral drugs
Original Research
Patients
Pediatrics
Pharynx
Preschool children
Rhinitis
rupatadine
safety
Statistical analysis
Urticaria
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Summary: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. 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. 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 (
ISSN:1178-6965
1178-6965
DOI:10.2147/JAA.S164632