Trial reportBritish journal of clinical pharmacology2005
Retrospective population pharmacokinetics of levocetirizine in atopic children receiving cetirizine: the ETAC study.
Trial report in British journal of clinical pharmacology, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed, 23 citations in OpenAlex.
- Levocetirizine does not prolong the QT/QTc interval in healthy subjects: results from a thorough QT study.European journal of clinical pharmacology · 2007Trial
- Confirming the Suitability of a Gentamicin Dosing Strategy in Neonates Using the Population Pharmacokinetic Approach with Truncated Sampling Duration.Children (Basel, Switzerland) · 2024Article
- Model-based exploration of the rationality of off-label use of cetirizine in Chinese pediatric patients: a prospective cohort study.Frontiers in pharmacology · 2024Article
- Rupatadine Oral Solution Titration by Body Weight in Paediatric Patients Suffering from Allergic Rhinitis: A Population Pharmacokinetic Study.Clinical pharmacology : advances and applications · 2021Article
- Pharmacokinetic studies in infants using minimal-risk study designs.Current clinical pharmacology · 2014Review
- Article
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo evaluate the population pharmacokinetics of levocetirizine in young children receiving long-term treatment with cetirizine.
methodsData were available from a randomized, double-blind, parallel group and placebo-controlled study of cetirizine in 343 young children between 12 and 24 months of age at entry, who were at high risk of developing asthma, but were not yet affected (ETAC study). Infants received oral drops of cetirizine at 0.25 mg kg(-1) twice daily for 18 months. Plasma concentration of the active enantiomer levocetirizine was determined in blood samples collected at months 3, 12 and 18 (1-3 samples per child). A one-compartment open model was fitted to the data using nonlinear mixed effects modelling (NONMEM). The influence of weight, age, gender, BSA and other covariates on CL/F and V/F was evaluated.
resultsCL/F increased linearly with weight by 0.044 l h(-1) kg(-1) over an intercept of 0.244 l h(-1), and V/F increased linearly with weight by 0.639 l kg(-1). Population estimates in children with weights of 8 and 20 kg were 0.60 and 1.13 l h(-1) for CL/F, and 5.1 and 12.8 l for V/F, respectively, with interpatient variabilities of 24.4% and 14.7%. Weight-normalized estimates of CL/F and V/F were higher than in adults. The estimated relative bioavailability was 0.28 in 12% of instances of suspected noncompliance. Levocetirizine pharmacokinetics were not influenced by severe allergy or aeroallergen sensitization. Results on the effects of concomitant medications or diseases were inconclusive due to limited positive cases. AUC(ss), calculated in compliant subjects using posterior estimates of the final model, was 1952 (1227-3319) microg l(-1) h (mean, min-max), a value similar to that in adults after intake of 5 mg oral solution (2036 (1414-2827) microg l(-1) h.
conclusionsThe model suggests that administration of levocetirizine 0.125 mg kg(-1) twice daily in children 12-48 months of age or weighing 8-20 kg yields the same exposure as in adults taking the recommended dose of 5 mg once daily.
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