Ole D Wolthers1, Sabine Mersmann2, Sanjeeva Dissanayake3. 1. Asthma and Allergy Clinic, Children's Clinic Randers, Dytmaersken 9, 8900, Randers, Denmark. akk.odws@dadlnet.dk. 2. Biostatistics and Clinical Data Science, Mundipharma Research GmbH & Co. KG, Limburg, Germany. 3. Medical Science, Mundipharma Research Limited, Cambridge, UK.
Abstract
BACKGROUND: For more than a decade, urinary free cortisol corrected for creatinine (OUFCC) has been used to assess the systemic bioactivity of inhaled corticosteroids in children with asthma. Paediatric normative ranges, however, have not been established. The aim of the present study was to define a preliminary range for OUFCC in Tanner stage 1 children. METHODS: A post hoc analysis was performed of 26 Tanner stage one children (aged 5-11 years) with mild asthma only requiring prn (pro re nata) treatment with short-acting β2-agonists, who participated in a 3-way cross-over knemometry study. The study comprised a run-in, two washout periods and three treatment periods (2 weeks each). Urine was collected at the end of each period. A normative range was derived using the 95% prediction interval for the geometric mean OUFCC, calculated from run-in and washout periods. RESULTS: Twenty-six children contributed 41 OUFCC values. The geometric mean OUFCC was 9.0 nmol/mmol (95% PI: 3.6, 22.7 nmol/mmol). CONCLUSIONS: The OUFCC preliminary normative range was 3.6 to 22.7 nmol/mmol in Tanner stage one children. A larger study in healthy children is warranted to confirm these findings and to assess potential differences in OUFCC across developmental stages and age groups, and by gender and race. EUDRACT NUMBER: 2013-004719-32, CLINICALTRIALS. GOV IDENTIFIER: NCT02063139.
BACKGROUND: For more than a decade, urinary free cortisol corrected for creatinine (OUFCC) has been used to assess the systemic bioactivity of inhaled corticosteroids in children with asthma. Paediatric normative ranges, however, have not been established. The aim of the present study was to define a preliminary range for OUFCC in Tanner stage 1 children. METHODS: A post hoc analysis was performed of 26 Tanner stage one children (aged 5-11 years) with mild asthma only requiring prn (pro re nata) treatment with short-acting β2-agonists, who participated in a 3-way cross-over knemometry study. The study comprised a run-in, two washout periods and three treatment periods (2 weeks each). Urine was collected at the end of each period. A normative range was derived using the 95% prediction interval for the geometric mean OUFCC, calculated from run-in and washout periods. RESULTS: Twenty-six children contributed 41 OUFCC values. The geometric mean OUFCC was 9.0 nmol/mmol (95% PI: 3.6, 22.7 nmol/mmol). CONCLUSIONS: The OUFCC preliminary normative range was 3.6 to 22.7 nmol/mmol in Tanner stage one children. A larger study in healthy children is warranted to confirm these findings and to assess potential differences in OUFCC across developmental stages and age groups, and by gender and race. EUDRACT NUMBER: 2013-004719-32, CLINICALTRIALS. GOV IDENTIFIER: NCT02063139.
Authors: Tom C Fardon; Daniel K C Lee; Kay Haggart; Lesley C McFarlane; Brian J Lipworth Journal: Am J Respir Crit Care Med Date: 2004-06-07 Impact factor: 21.405