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

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Abstract

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.

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Most cited references 23

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Global map of the prevalence of symptoms of rhinoconjunctivitis in children: The International Study of Asthma and Allergies in Childhood (ISAAC) Phase Three.

N Aït-Khaled, Dipan Shah, N Aït-Khaled … (2009)

Phase One of the International Study of Asthma and Allergies in Childhood (ISAAC) measured the global patterns of prevalence and severity of symptoms of rhinoconjunctivitis in children in 1993-1997. International Study of Asthma and Allergies in Childhood Phase Three was a cross-sectional survey performed 5-10 years after Phase One using the same methodology. Phase Three covered all of the major regions of the world and involved 1 059 053 children of 2 age groups from 236 centres in 98 countries. The average overall prevalence of current rhinoconjunctivitis symptoms was 14.6% for the 13- to 14-year old children (range 1.0-45%). Variation in the prevalence of severe rhinoconjunctivitis symptoms was observed between centres (range 0.0-5.1%) and regions (range 0.4% in western Europe to 2.3% in Africa), with the highest prevalence being observed mainly in the centres from middle and low income countries, particularly in Africa and Latin America. Co-morbidity with asthma and eczema varied from 1.6% in the Indian sub-continent to 4.7% in North America. For 6- to 7-year old children, the average prevalence of rhinoconjunctivitis symptoms was 8.5%, and large variations in symptom prevalence were also observed between regions, countries and centres. Wide global variations exist in the prevalence of current rhinoconjunctivitis symptoms, being higher in high vs low income countries, but the prevalence of severe symptoms was greater in less affluent countries. Co-morbidity with asthma is high particularly in Africa, North America and Oceania. This global map of symptom prevalence is of clinical importance for health professionals.

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BSACI guidelines for the management of allergic and non‐allergic rhinitis

G. K. Scadding, S. R. Durham, R Mirakian … (2007)

Summary This guidance for the management of patients with allergic and non‐allergic rhinitis has been prepared by the Standards of Care Committee (SOCC) of the British Society for Allergy and Clinical Immunology (BSACI). The guideline is based on evidence as well as on expert opinion and is for use by both adult physicians and paediatricians practicing in allergy. The recommendations are evidence graded. During the development of these guidelines, all BSACI members were included in the consultation process using a web‐based system. Their comments and suggestions were carefully considered by the SOCC. Where evidence was lacking, consensus was reached by the experts on the committee. Included in this guideline are clinical classification of rhinitis, aetiology, diagnosis, investigations and management including subcutaneous and sublingual immunotherapy. There are also special sections for children, co‐morbid associations and pregnancy. Finally, we have made recommendations for potential areas of future research.

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The influence of gender and atopy on the natural history of rhinitis in the first 18 years of life.

Wameq A. Raza, W. Karmaus, R Kurukulaaratchy … (2011)

Longitudinal studies of the natural history of childhood and adolescent rhinitis are lacking. To investigate the natural history of rhinitis up to 18 years of age, and how that is influenced by gender and atopy. The Isle of Wight birth cohort was recruited in 1989 (n=1456). Questionnaire data on nasal symptoms (rhinitis) were collected at 1, 2, 4, 10 and 18 years of age. To define atopy, skin prick tests were conducted at 4, 10 and 18 years. The 12-month period prevalence plus positive and negative transitions (defined as change in disease status in two consecutive study assessments) were stratified by gender and atopic status. Overall rhinitis prevalence increased from 5.4% at 4 years to 35.8% at 18 years (P<0.001), without gender difference. Atopic rhinitis prevalence increased steadily from 3.4% at 4 years to 27.3% at 18 years (P<0.001), was commoner in boys at 18 years (P=0.02) and associated with greater positive transition in boys from 10 to 18 years (P=0.01). Prevalence of non-atopic rhinitis also increased from 4 to 18 years (P=0.003) and was greater in girls at 18 years (P<0.001) reflecting higher female positive transition from 10 to 18 years (P<0.001). Non-atopic rhinitis negative transition (remission) was highest in early life and reduced in later childhood/adolescence. Atopic rhinitis becomes increasingly common as children grow into adolescents, with stronger associations to male gender. Non-atopic rhinitis shows a female predominance at 18 years as girls 'grow into' it more during adolescence. Our findings suggest differential gender effects on the increasing prevalence of both atopic and non-atopic rhinitis in adolescence. A better understanding of how gender and atopic status influence rhinitis during adolescence emerges from this study. Application of such knowledge could help to improve clinical recognition, judge prognosis and ultimately improve management of this common condition. © 2011 Blackwell Publishing Ltd.

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Author and article information

Journal

Journal ID (nlm-ta): J Asthma Allergy

Journal ID (iso-abbrev): J Asthma Allergy

Journal ID (publisher-id): Journal of Asthma and Allergy

Title: Journal of Asthma and Allergy

Publisher: Dove Medical Press

ISSN (Electronic): 1178-6965

Publication date Collection: 2018

Publication date (Electronic): 04 September 2018

Volume: 11

Pages: 225-231

Affiliations

[1 ]Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain, MValleC@ 123456santpau.cat

[2 ]Clinical Development, R&D, J. Uriach y Compañía, S.A., Barcelona, Spain

[3 ]Pharmacokinetic/Pharmacodynamic Modeling and Simulation, Sant Pau Institute of Biomedical Research (IIB-Sant Pau), Barcelona, Spain, MValleC@ 123456santpau.cat

[4 ]Allergic Department, Parow Research, Cape Town, South Africa

[5 ]Allergy Diagnostic and Clinical Research Unit, Department of Medicine, University of Cape Town Lung Institute, Cape Town, South Africa

Author notes

Correspondence: Marta Valle, Pharmacokinetic/Pharmacodynamic Modeling and Simulation, Sant Pau Institute of Biomedical Research (IIB-Sant Pau), Sant Antoni María Claret, 167, 08025, Barcelona, Spain, Email MValleC@ 123456santpau.cat

Article

Publisher ID: jaa-11-225

DOI: 10.2147/JAA.S164632

PMC ID: 6128281

PubMed ID: 30214250

SO-VID: e361b177-b21a-4b5e-9c41-068785f681f9

License:

The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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

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Most cited references 23

Global map of the prevalence of symptoms of rhinoconjunctivitis in children: The International Study of Asthma and Allergies in Childhood (ISAAC) Phase Three.

BSACI guidelines for the management of allergic and non‐allergic rhinitis

The influence of gender and atopy on the natural history of rhinitis in the first 18 years of life.

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