Evidence map›Paper›PMID 29256049›Full record

Trial reportClinical drug investigation2018

A Pilot Study of the Normative Range of Overnight Urinary Free Cortisol Corrected for Creatinine in Children.

Ole D Wolthers, Sabine Mersmann, Sanjeeva Dissanayake

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Clinical drug investigation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02063139 (A Single), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT02063139 phase2completednot on this map

A Single (Assessor)-Blind, Randomised, Three-period, Cross-over Study to Compare the Safety of Flutiform pMDI, Fluticasone pMDI, and Beclometasone Autohaler in Paediatric Subjects Aged 5 to Less Than 12 Years With Mild Persistent Asthma by Means of Knemometry

TypeinterventionalSponsorMundipharma Research LimitedRan2014 to 2015Enrolled48ConditionsMild Persistent AsthmaArmsFlutiform 50/5 ug (2 puffs bid) pMDI, Fluticasone 50 ug (2puffs bid) pMDI, Beclometasone Autohaler 50 ug (2 puffs bid)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Ole D WolthersAsthma and Allergy Clinic, Children's Clinic Randers, Dytmaersken 9, 8900, Randers, Denmark. akk.odws@dadlnet.dk.
Sabine MersmannBiostatistics and Clinical Data Science, Mundipharma Research GmbH & Co. KG, Limburg, Germany.
Sanjeeva DissanayakeMedical Science, Mundipharma Research Limited, Cambridge, UK.

Funding

The study was funded by Mundipharma Research Limited, Cambridge, UK. FLT2540
6 · The paper itself

Abstract

backgroundFor 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.

methodsA 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 β

resultsTwenty-six children contributed 41 OUFCC values. The geometric mean OUFCC was 9.0 nmol/mmol (95% PI: 3.6, 22.7 nmol/mmol).

conclusionsThe 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.

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsAndrostadienesAnti-Asthmatic AgentsAsthmaChildChild, PreschoolCreatinineCross-Over StudiesDrug CombinationsEthanolaminesFemaleFluticasoneFormoterol FumarateHumansHydrocortisoneAdrenergic beta-2 Receptor AgonistsAndrostadienesAnti-Asthmatic AgentsCreatinineDrug CombinationsEthanolaminesFluticasonefluticasone-formoterolFormoterol FumarateHydrocortisone

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.