- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03691961
Kortikosteroider/β2-agonister i hår hos astmatiske patienter (CorticHair) (CorticHair)
Terapeutisk lægemiddelovervågning af kortikosteroider/β2-agonister i hår hos astmatiske patienter: et åbent gennemførlighedsstudie
Dette gennemførlighedsstudie vil være åbent med to dosisgrupper: patienter, der får budesonid/formoterol Turbuhaler® i en samlet daglig dosis [400 til 800 µg[ (gruppe 1) og patienter, der får en samlet daglig dosis ≥800 µg/dag (gruppe 2) ) for at undersøge, om der er en sammenhæng mellem dosis og hårkoncentration.
Formålet med denne gennemførlighedsundersøgelse er at bestemme, om det produkt, der administreres til patienten, er sporbart og kvantificerbart i hår for at have et middel til at overvåge overholdelse af behandlingen. Denne undersøgelse evaluerer på ingen måde effektiviteten eller sikkerheden af lægemidlet, som vil blive brugt i overensstemmelse med dets markedsføringstilladelse.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Astma rammer 3-10 % af den europæiske befolkning og er en heterogen sygdom i sine kliniske manifestationer og også i sin reaktion på behandling. Da terapi ofte startes i en ung alder og gives over mange år, med justeringer af sygdomskontrol, er langsigtet adhærens og effektivitet særlige bekymringer.
Overholdelse af inhalationskontrolmedicin er en stor udfordring for at opnå sygdomsbekæmpelse og for at undgå alvorlige astmaopblussen eller unødvendig intensivering af behandlingen. Udover bekymringer om overholdelse, kan dårlig astmakontrol også være konsekvensen af en dårlig inhalationsteknik og den resulterende utilstrækkelige lægemiddeleksponering.
For at overvinde overholdelsesproblemer opfordres patienter til selv at styre deres sygdom, og brugen af nye teknologier såsom inhalatorpåmindelser, elektroniske enheder og/eller smartphone-applikationer kan være nyttig. Selvom der er en margen til at forbedre og overvåge overholdelse, er det meget sværere at vurdere effektiviteten af inhalationsteknikken i den daglige rutine og dens konsekvenser med hensyn til lægemiddeleksponering.
Den traditionelle overvågning af farmakologiske terapier involverer terapeutisk lægemiddelovervågning, dvs. målingen af lægemiddelkoncentrationen i plasma. Men lægemiddelkoncentrationen i plasma afspejler stort set kun mængden af lægemiddel i kroppen inden for de sidste 24-48 timer. Derfor bruges terapeutisk lægemiddelmonitorering ikke til inhalerede astmabehandlinger, delvist på grund af den begrænsede interesse i kun at vurdere en 24-48 timers eksponering og på grund af de meget lave plasmakoncentrationer, som er meget udfordrende at måle.
Da lægemidler til stede i blodbanen også når og forbliver i det dannede hår, hvor deres koncentrationer kan måles og fortolkes som en samlet kronisk eksponering, kan håranalyse blive et værdifuldt værktøj til overvågning af inhalerede astmabehandlinger med brug af meget specifik masse spektrometriteknikker og af de mest følsomme sidste generations massespektrometre.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Suresnes, Frankrig, 92150
- Foch hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- Udlevering af informeret samtykke forud for enhver undersøgelsesspecifik procedure
- Ambulante patienter med astma, af begge køn, i alderen ≥18 og <50 år ved besøg 1
- Kontrolleret eller delvist kontrolleret astma i henhold til Global Initiative for Asthma (GINA) guideline
- Modtagelse af en konstant daglig dosis ≥400 µg budesonid af budesonid/formoterol Turbuhaler® i mere end 2 måneder
- Der er ikke planlagt nogen behandlingsnedgang i de næste 3 måneder
- ACQ (Asthma Control Questionnaire) score ≤ 1,50
- Patient med sygesikring
Ekskluderingskriterier:
- Gravide kvinder eller kvinder, der ønsker at blive gravide inden for de næste 3 måneder
- Patienter med body mass index (BMI) <18 eller >30
- Patienter med kendt nyre- eller leversygdom (kreatininclearance < 60 ml/min/1,73) m² eller alaninaminotransferase (ALAT) > 5N)
- Rygere eller tidligere rygere < 3 år
- Patienter med samtidig astma og kronisk obstruktiv lungesygdom (KOL) (eller defineret som havende astma-KOL overlapningssyndrom)
- Andre budesonid- eller formoterolholdige lægemidler (f.eks. Foradil®, Rhinocort®, Mikicort®, Entocort®...)
- CYP3A4-inducere (systemisk kortikosteroid, rifampicin, phenobarbital, carbamazepin...)
- CYP3A4-hæmmere (makrolider, azol-svampemidler, valproinsyre, amiodaron, fluoxetin)
- Hårbehandling (farvning, blegning, permanent...)
- Hårløse patienter, hårimplantater eller hårextensions
- Længde af hår fra vertex posterior region < 5 cm eller planlægger at klippe hår fra denne region kortere end 5 cm inden for de næste 4 måneder
- Patient frihedsberøvet ved retslig eller administrativ afgørelse
- Major beskyttet ved lov
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: ANDET
- Tildeling: NON_RANDOMIZED
- Interventionel model: PARALLEL
- Maskning: INGEN
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
EKSPERIMENTEL: Medium dosis af Symbicort Turbuhaler®
Populationen er astmatiske patienter, der opfylder inklusions- og eksklusionskriterierne, for hvem den optimerede samlede daglige dosis til behandling af sygdommen er ≥400 til 800 µg budesonid af budesonid/formoterol Symbicort Turbuhaler®. Hårprøvetagning efter 4 måneders behandling. Analyse af hårs lægemiddelkoncentrationer. |
Efter 4 måneders behandling klippes et hårstrå fra toppunktet bagerste region af hovedbunden omkring bredden af en tynd blyant og med en længde lig med eller større end 3 cm.
Hårets koncentrationer af budesonid/formoterol analyseres med massespektrometri.
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EKSPERIMENTEL: Høj dosis af Symbicort Turbuhaler®
Populationen er astmatiske patienter, der opfylder inklusions- og eksklusionskriterierne, for hvem den optimerede samlede daglige dosis til behandling af sygdommen er ≥800 µg budesonid af budesonid/formoterol Symbicort TurbuhalerTurbuhaler®. Hårprøvetagning efter 4 måneders behandling. Analyse af hårs lægemiddelkoncentrationer. |
Efter 4 måneders behandling klippes et hårstrå fra toppunktet bagerste region af hovedbunden omkring bredden af en tynd blyant og med en længde lig med eller større end 3 cm.
Hårets koncentrationer af budesonid/formoterol analyseres med massespektrometri.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Budesonid/formoterol-hårkoncentrationer (aktivt stof og metabolitter)
Tidsramme: 4 måneder
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Efter 4 måneders behandling analyseres hårets koncentrationer af budesonid/formoterol med massespektrometri.
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4 måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Budesonid/formoterol koncentration i tre 1 cm hårsegmenter (aktivt stof og metabolitter)
Tidsramme: 4 måneder
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Efter 4 måneders behandling analyseres koncentrationerne af budesonid/formoterol i tre 1-cm hårsegmenter med massespektrometri.
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4 måneder
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Budesonid/formoterol hårs koncentration sammenlignet med den daglige observation.
Tidsramme: 4 måneder
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Patientens kumulative dosis estimeres ud fra daglig observation registreret af patienten i observationsjournalen.
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4 måneder
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Korrelation mellem budesonid/formoterol-hårkoncentrationer, forceret ekspiratorisk volumen på 1 sekund (FEV1) og astmakontrolspørgeskema (ACQ)
Tidsramme: 4 måneder
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FEV1 (målt i henhold til en standardiseret spirometriteknik) og ACQ (patienter med en score under 1,0 vil have tilstrækkeligt kontrolleret astma og over 1,0 vil deres astma ikke være godt kontrolleret) indsamles ved inklusionsbesøget og 4 måneders besøget
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4 måneder
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Stanislas Grassin-Delyle, Dr, University Versailles Saint Quentin / Foch Hospital
Publikationer og nyttige links
Generelle publikationer
- Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Al-Jahdali H, Ahmed A, Al-Harbi A, Khan M, Baharoon S, Bin Salih S, Halwani R, Al-Muhsen S. Improper inhaler technique is associated with poor asthma control and frequent emergency department visits. Allergy Asthma Clin Immunol. 2013 Mar 6;9(1):8. doi: 10.1186/1710-1492-9-8.
- Alonso L, Fuchs E. The hair cycle. J Cell Sci. 2006 Feb 1;119(Pt 3):391-3. doi: 10.1242/jcs.02793. No abstract available.
- Alvarez JC, Abe E, Etting I, Le Guen M, Devillier P, Grassin-Delyle S. Quantification of remifentanil and propofol in human plasma: a LC-MS/MS assay validated according to the EMA guideline. Bioanalysis. 2015;7(13):1675-84. doi: 10.4155/bio.15.89.
- Alvarez JC, Charbit B, Grassin-Delyle S, Demolis JL, Funck-Brentano C, Abe E. Human plasma quantification of droperidol and ondansetron used in preventing postoperative nausea and vomiting with a LC/ESI/MS/MS method. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Jan 15;879(2):186-90. doi: 10.1016/j.jchromb.2010.12.001. Epub 2010 Dec 16.
- Auchus RJ. Steroid assays and endocrinology: best practices for basic scientists. Endocrinology. 2014 Jun;155(6):2049-51. doi: 10.1210/en.2014-7534. No abstract available.
- Baxi SM, Greenblatt RM, Bacchetti P, Jin C, French AL, Keller MJ, Augenbraun MH, Gange SJ, Liu C, Mack WJ, Gandhi M; Women's Interagency HIV Study (WIHS). Nevirapine Concentration in Hair Samples Is a Strong Predictor of Virologic Suppression in a Prospective Cohort of HIV-Infected Patients. PLoS One. 2015 Jun 8;10(6):e0129100. doi: 10.1371/journal.pone.0129100. eCollection 2015.
- Bevalot F, Gaillard Y, Lhermitte MA, Pepin G. Analysis of corticosteroids in hair by liquid chromatography-electrospray ionization mass spectrometry. J Chromatogr B Biomed Sci Appl. 2000 Apr 14;740(2):227-36. doi: 10.1016/s0378-4347(00)00085-2.
- Borges NC, Astigarraga RB, Sverdloff CE, Borges BC, Paiva TR, Galvinas PR, Moreno RA. Budesonide quantification by HPLC coupled to atmospheric pressure photoionization (APPI) tandem mass spectrometry. Application to a comparative systemic bioavailability of two budesonide formulations in healthy volunteers. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Feb 1;879(3-4):236-42. doi: 10.1016/j.jchromb.2010.12.003. Epub 2010 Dec 13.
- Buscher BA, Jagfeldt H, Sandman H, Brust-van Schaik R, van Schaik F, Brull LP. The determination of budesonide and fluticasone in human sputum samples collected from COPD patients using LC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2012 Jan 1;880(1):6-11. doi: 10.1016/j.jchromb.2011.10.029. Epub 2011 Nov 16.
- Capron A, Antunes MV, Wagner SC, Mattevi VS, Vieira N, Leite R, Reginato F, Capra M, Fogliatto L, Wallemacq P, Linden R. First report of imatinib measurement in hair: Method development and preliminary evaluation of the relation between hair and plasma concentrations with therapeutic response in chronic myeloid leukemia. Clin Chim Acta. 2016 Jan 30;453:42-7. doi: 10.1016/j.cca.2015.11.032. Epub 2015 Dec 3.
- Chalmers GW, Macleod KJ, Little SA, Thomson LJ, McSharry CP, Thomson NC. Influence of cigarette smoking on inhaled corticosteroid treatment in mild asthma. Thorax. 2002 Mar;57(3):226-30. doi: 10.1136/thorax.57.3.226.
- Chèze, M. and Gaulier, J.-M. (2014). Chapter 8 - Drugs Involved in Drug-Facilitated Crimes (DFC): Analytical Aspects: 2-Hair A2 - Kintz, Pascal. Toxicological Aspects of Drug-Facilitated Crimes. Oxford, Academic Press: 181-222.
- Choi HI, Choi GI, Kim EK, Choi YJ, Sohn KC, Lee Y, Kim CD, Yoon TJ, Sohn HJ, Han SH, Kim S, Lee JH, Lee YH. Hair greying is associated with active hair growth. Br J Dermatol. 2011 Dec;165(6):1183-9. doi: 10.1111/j.1365-2133.2011.10625.x.
- Cirimele V, Kintz P, Dumestre V, Goulle JP, Ludes B. Identification of ten corticosteroids in human hair by liquid chromatography-ionspray mass spectrometry. Forensic Sci Int. 2000 Jan 10;107(1-3):381-8. doi: 10.1016/s0379-0738(99)00180-2.
- Cirimele V, Tracqui A, Kintz P, Ludes B. First identification of prednisone in human hair by liquid chromatography-ionspray mass spectrometry. J Anal Toxicol. 1999 May-Jun;23(3):225-6. doi: 10.1093/jat/23.3.225. No abstract available.
- Cochrane MG, Bala MV, Downs KE, Mauskopf J, Ben-Joseph RH. Inhaled corticosteroids for asthma therapy: patient compliance, devices, and inhalation technique. Chest. 2000 Feb;117(2):542-50. doi: 10.1378/chest.117.2.542.
- Cone EJ. Mechanisms of drug incorporation into hair. Ther Drug Monit. 1996 Aug;18(4):438-43. doi: 10.1097/00007691-199608000-00022.
- Cooper GA, Kronstrand R, Kintz P; Society of Hair Testing. Society of Hair Testing guidelines for drug testing in hair. Forensic Sci Int. 2012 May 10;218(1-3):20-4. doi: 10.1016/j.forsciint.2011.10.024. Epub 2011 Nov 15.
- Cuypers E, Flinders B, Bosman IJ, Lusthof KJ, Van Asten AC, Tytgat J, Heeren RMA. Hydrogen peroxide reactions on cocaine in hair using imaging mass spectrometry. Forensic Sci Int. 2014 Sep;242:103-110. doi: 10.1016/j.forsciint.2014.06.035. Epub 2014 Jul 7.
- Dalby C, Polanowski T, Larsson T, Borgstrom L, Edsbacker S, Harrison TW. The bioavailability and airway clearance of the steroid component of budesonide/formoterol and salmeterol/fluticasone after inhaled administration in patients with COPD and healthy subjects: a randomized controlled trial. Respir Res. 2009 Oct 31;10(1):104. doi: 10.1186/1465-9921-10-104.
- DAVIS BK. Phases of the hair-growth cycle. Nature. 1962 May 19;194:694. doi: 10.1038/194694a0. No abstract available.
- Deventer K, Mikulcikova P, Van Hoecke H, Van Eenoo P, Delbeke FT. Detection of budesonide in human urine after inhalation by liquid chromatography-mass spectrometry. J Pharm Biomed Anal. 2006 Oct 11;42(4):474-9. doi: 10.1016/j.jpba.2006.05.016. Epub 2006 Jul 12.
- Deventer K, Pozo OJ, Delbeke FT, Van Eenoo P. Quantitative detection of inhaled formoterol in human urine and relevance to doping control analysis. Drug Test Anal. 2012 Jun;4(6):449-54. doi: 10.1002/dta.418. Epub 2012 Mar 22.
- Dimova H, Wang Y, Pommery S, Moellmann H, Hochhaus G. SPE/RIA vs LC/MS for measurement of low levels of budesonide in plasma. Biomed Chromatogr. 2003 Jan;17(1):14-20. doi: 10.1002/bmc.204.
- Duvivier WF, Peeters RJ, van Beek TA, Nielen MW. Evidence based decontamination protocols for the removal of external Delta9-tetrahydrocannabinol (THC) from contaminated hair. Forensic Sci Int. 2016 Feb;259:110-8. doi: 10.1016/j.forsciint.2015.12.014. Epub 2015 Dec 19.
- Fabresse, N. (2015). Mise au point et validation d'une méthode de dosage des anabolisants stéroïdiens dans le sang et les cheveux par spectrométrie de masse haute résolution Orbitrap Application à deux cas médico-légaux, http://www.sudoc.fr/188207155: 93.
- Fabresse N, Grassin-Delyle S, Etting I, Alvarez JC. Detection and quantification of 12 anabolic steroids and analogs in human whole blood and 20 in hair using LC-HRMS/MS: application to real cases. Int J Legal Med. 2017 Jul;131(4):989-999. doi: 10.1007/s00414-017-1552-3. Epub 2017 Feb 24.
- FDA.
- Foster JM, Usherwood T, Smith L, Sawyer SM, Xuan W, Rand CS, Reddel HK. Inhaler reminders improve adherence with controller treatment in primary care patients with asthma. J Allergy Clin Immunol. 2014 Dec;134(6):1260-1268.e3. doi: 10.1016/j.jaci.2014.05.041. Epub 2014 Jul 22.
- Gaillard Y, Vayssette F, Pepin G. Compared interest between hair analysis and urinalysis in doping controls. Results for amphetamines, corticosteroids and anabolic steroids in racing cyclists. Forensic Sci Int. 2000 Jan 10;107(1-3):361-79. doi: 10.1016/s0379-0738(99)00179-6.
- Gamble J, Stevenson M, McClean E, Heaney LG. The prevalence of nonadherence in difficult asthma. Am J Respir Crit Care Med. 2009 Nov 1;180(9):817-22. doi: 10.1164/rccm.200902-0166OC. Epub 2009 Jul 30.
- Gandhi M, Ameli N, Bacchetti P, Anastos K, Gange SJ, Minkoff H, Young M, Milam J, Cohen MH, Sharp GB, Huang Y, Greenblatt RM. Atazanavir concentration in hair is the strongest predictor of outcomes on antiretroviral therapy. Clin Infect Dis. 2011 May;52(10):1267-75. doi: 10.1093/cid/cir131.
- Gandhi M, Greenblatt RM, Bacchetti P, Jin C, Huang Y, Anastos K, Cohen M, Dehovitz JA, Sharp GB, Gange SJ, Liu C, Hanson SC, Aouizerat B; Women's Interagency HIV Study. A single-nucleotide polymorphism in CYP2B6 leads to >3-fold increases in efavirenz concentrations in plasma and hair among HIV-infected women. J Infect Dis. 2012 Nov;206(9):1453-61. doi: 10.1093/infdis/jis508. Epub 2012 Aug 20.
- Shen HH, Du XF, Ying SM. [Comparison of Chinese guideline for asthma managment and prevention (2016 update) and global initiative for asthma (2017 update)]. Zhonghua Jie He He Hu Xi Za Zhi. 2018 Mar 12;41(3):166-168. doi: 10.3760/cma.j.issn.1001-0939.2018.03.003. No abstract available. Chinese.
- Grassin Delyle S, Abe E, Batisse A, Tremey B, Fischler M, Devillier P, Alvarez JC. A validated assay for the quantitative analysis of tranexamic acid in human serum by liquid chromatography coupled with electrospray ionization mass spectrometry. Clin Chim Acta. 2010 Mar;411(5-6):438-43. doi: 10.1016/j.cca.2010.01.005. Epub 2010 Jan 11.
- Grassin Delyle S, Abe E, Devillier P, Alvarez JC. Determination of rimonabant in human plasma and hair by liquid chromatography-mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Sep 1;872(1-2):115-20. doi: 10.1016/j.jchromb.2008.07.041. Epub 2008 Aug 5.
- Handelsman DJ, Wartofsky L. Requirement for mass spectrometry sex steroid assays in the Journal of Clinical Endocrinology and Metabolism. J Clin Endocrinol Metab. 2013 Oct;98(10):3971-3. doi: 10.1210/jc.2013-3375. No abstract available.
- He G, Lu J, Wang X, Xu Y, Wu Y, Dong Y, Shen L, He Z, Zhao J, Yuan H. An improved liquid chromatography-tandem mass spectrometric method to quantify formoterol in human urine. J Chromatogr Sci. 2014 Sep;52(8):848-51. doi: 10.1093/chromsci/bmt127. Epub 2013 Sep 12.
- Hoelzle C, Scheufler F, Uhl M, Sachs H, Thieme D. Application of discriminant analysis to differentiate between incorporation of cocaine and its congeners into hair and contamination. Forensic Sci Int. 2008 Mar 21;176(1):13-8. doi: 10.1016/j.forsciint.2007.07.020. Epub 2007 Dec 11.
- Josefsson M, Sabanovic A. Sample preparation on polymeric solid phase extraction sorbents for liquid chromatographic-tandem mass spectrometric analysis of human whole blood--a study on a number of beta-agonists and beta-antagonists. J Chromatogr A. 2006 Jul 7;1120(1-2):1-12. doi: 10.1016/j.chroma.2006.03.013. Epub 2006 Apr 4.
- Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999 Oct;14(4):902-7. doi: 10.1034/j.1399-3003.1999.14d29.x.
- Juniper EF, Svensson K, Mork AC, Stahl E. Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med. 2005 May;99(5):553-8. doi: 10.1016/j.rmed.2004.10.008. Epub 2004 Nov 26.
- Jurado C, Kintz P, Menendez M, Repetto M. Influence of the cosmetic treatment of hair on drug testing. Int J Legal Med. 1997;110(3):159-63. doi: 10.1007/s004140050056.
- Kintz P. Value of the concept of minimal detectable dosage in human hair. Forensic Sci Int. 2012 May 10;218(1-3):28-30. doi: 10.1016/j.forsciint.2011.10.018. Epub 2011 Oct 20.
- Kintz P, Alvarez JC, Deveaux M, Dumestre V, Gaillard Y, Gaulier JM. Conflicting hair testing results can have an impact in courts: interpretation of single exposure to zolpidem. J Anal Toxicol. 2014 Jun;38(5):304-5. doi: 10.1093/jat/bku014. Epub 2014 Mar 11. No abstract available.
- Kintz P, Cirimele V, Ludes B. Pharmacological criteria that can affect the detection of doping agents in hair. Forensic Sci Int. 2000 Jan 10;107(1-3):325-34. doi: 10.1016/s0379-0738(99)00176-0.
- Kintz P, Dumestre-Toulet V, Jamey C, Cirimele V, Ludes B. Doping control for beta-adrenergic compounds through hair analysis. J Forensic Sci. 2000 Jan;45(1):170-4.
- Kronkvist K, Gustavsson M, Wendel AK, Jaegfeldt H. Automated sample preparation for the determination of budesonide in plasma samples by liquid chromatography and tandem mass spectrometry. J Chromatogr A. 1998 Oct 9;823(1-2):401-9. doi: 10.1016/s0021-9673(98)00592-5.
- Kronstrand R, Ahlner J, Dizdar N, Larson G. Quantitative analysis of desmethylselegiline, methamphetamine, and amphetamine in hair and plasma from Parkinson patients on long-term selegiline medication. J Anal Toxicol. 2003 Apr;27(3):135-41. doi: 10.1093/jat/27.3.135.
- Kronstrand R, Roman M, Hedman M, Ahlner J, Dizdar N. Dose-hair concentration relationship and pigmentation effects in patients on low-dose clozapine. Forensic Sci Med Pathol. 2007 Jun;3(2):107-14. doi: 10.1007/s12024-007-0010-9. Epub 2007 May 9.
- LeBeau MA, Montgomery MA, Brewer JD. The role of variations in growth rate and sample collection on interpreting results of segmental analyses of hair. Forensic Sci Int. 2011 Jul 15;210(1-3):110-6. doi: 10.1016/j.forsciint.2011.02.015. Epub 2011 Mar 6.
- Lee KM, Kim HJ, Son J, Park JH, Kwon OS, Lee J. Simple quantitation of formoterol and 11-nor-Delta(9)-tetrahydrocannabinol-9-carboxylic acid in human urine by liquid chromatography-tandem mass spectrometry in doping control. J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Sep 15;967:8-12. doi: 10.1016/j.jchromb.2014.07.009. Epub 2014 Jul 14.
- Lemaire-Hurtel, A.-S., Durand-Maugard, C., Berquin, P., Antonios, M., Hary, L., Andrejak, M., Masson, H., Manaouil, C., Abe, E. and Alvarez, J.-C. (2010).
- Li N, Tattam B, Brow KF, Seale JP. Quantification of epimeric budesonide and fluticasone propionate in human plasma by liquid chromatography-atmospheric pressure chemical ionization tandem mass spectrometry. J Chromatogr B Biomed Sci Appl. 2001 Sep 25;761(2):177-85. doi: 10.1016/s0378-4347(01)00329-2.
- Li YN, Tattam B, Brown KF, Seale JP. Determination of epimers 22R and 22S of budesonide in human plasma by high-performance liquid chromatography-atmospheric pressure chemical ionization mass spectrometry. J Chromatogr B Biomed Appl. 1996 Aug 30;683(2):259-68. doi: 10.1016/0378-4347(96)00111-9.
- Lindberg C, Blomqvist A, Paulson J. Determination of (22R,S)budesonide in human plasma by automated liquid chromatography/thermospray mass spectrometry. Biol Mass Spectrom. 1992 Nov;21(11):525-33. doi: 10.1002/bms.1200211102.
- Liu AY, Yang Q, Huang Y, Bacchetti P, Anderson PL, Jin C, Goggin K, Stojanovski K, Grant R, Buchbinder SP, Greenblatt RM, Gandhi M. Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP). PLoS One. 2014 Jan 8;9(1):e83736. doi: 10.1371/journal.pone.0083736. eCollection 2014.
- Loussouarn G, Lozano I, Panhard S, Collaudin C, El Rawadi C, Genain G. Diversity in human hair growth, diameter, colour and shape. An in vivo study on young adults from 24 different ethnic groups observed in the five continents. Eur J Dermatol. 2016 Apr 1;26(2):144-54. doi: 10.1684/ejd.2015.2726.
- Lu Y, Sun Z, Zhang Y, Chen X, Zhong D. Simultaneous quantification of 22R and 22S epimers of budesonide in human plasma by ultra-high-performance liquid chromatography-tandem mass spectrometry: application in a stereoselective pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2013 Mar 15;921-922:27-34. doi: 10.1016/j.jchromb.2013.01.015. Epub 2013 Jan 28.
- Mancebo, M., Grassin-Delyle, S., Essid, A., Bataille, J., Guérard, P., Delyle, A. G. and Alvarez, J.-C. (2011).
- Mascher DG, Zech K, Nave R, Kubesch KM, Mascher HJ. Ultra-sensitive determination of Formoterol in human serum by high performance liquid chromatography and electrospray tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Jan 2;830(1):25-34. doi: 10.1016/j.jchromb.2005.10.022. Epub 2005 Nov 7.
- Mazzarino M, de la Torre X, Fiacco I, Pompei C, Calabrese F, Botre F. A simplified procedure for the analysis of formoterol in human urine by liquid chromatography-electrospray tandem mass spectrometry: application to the characterization of the metabolic profile and stability of formoterol in urine. J Chromatogr B Analyt Technol Biomed Life Sci. 2013 Jul 15;931:75-83. doi: 10.1016/j.jchromb.2013.05.021. Epub 2013 May 28.
- Millar SE. Molecular mechanisms regulating hair follicle development. J Invest Dermatol. 2002 Feb;118(2):216-25. doi: 10.1046/j.0022-202x.2001.01670.x.
- Miller-Larsson A, Mattsson H, Hjertberg E, Dahlback M, Tunek A, Brattsand R. Reversible fatty acid conjugation of budesonide. Novel mechanism for prolonged retention of topically applied steroid in airway tissue. Drug Metab Dispos. 1998 Jul;26(7):623-30.
- Miramont S, Alvarez JC, Bourgogne E, Cheron G. [Passive cocaine inhalation by a 25-month-old child]. Arch Pediatr. 2013 Jun;20(6):654-6. doi: 10.1016/j.arcped.2013.03.006. Epub 2013 Apr 19. French.
- Mortimer KJ, Harrison TW, Tang Y, Wu K, Lewis S, Sahasranaman S, Hochhaus G, Tattersfield AE. Plasma concentrations of inhaled corticosteroids in relation to airflow obstruction in asthma. Br J Clin Pharmacol. 2006 Oct;62(4):412-9. doi: 10.1111/j.1365-2125.2006.02712.x.
- Nilsson K, Andersson M, Beck O. Phospholipid removal combined with a semi-automated 96-well SPE application for determination of budesonide in human plasma with LC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Nov 1;970:31-5. doi: 10.1016/j.jchromb.2014.08.035. Epub 2014 Sep 6.
- Noppe G, de Rijke YB, Dorst K, van den Akker EL, van Rossum EF. LC-MS/MS-based method for long-term steroid profiling in human scalp hair. Clin Endocrinol (Oxf). 2015 Aug;83(2):162-6. doi: 10.1111/cen.12781. Epub 2015 Apr 27.
- Pecoraro, V. and Astore, I. P. L. (1990). Measurements of hair growth under physiological conditions. Hair and Hair Diseases. C. E. Orfanos and R. Happle. Berlin, Heidelberg, Springer Berlin Heidelberg: 237-254.
- Potsch L. A discourse on human hair fibers and reflections on the conservation of drug molecules. Int J Legal Med. 1996;108(6):285-93. doi: 10.1007/BF02432122.
- Pragst F, Balikova MA. State of the art in hair analysis for detection of drug and alcohol abuse. Clin Chim Acta. 2006 Aug;370(1-2):17-49. doi: 10.1016/j.cca.2006.02.019. Epub 2006 Mar 6.
- Pritchett JS, Phinney KW. Influence of chemical straightening on the stability of drugs of abuse in hair. J Anal Toxicol. 2015 Jan-Feb;39(1):13-6. doi: 10.1093/jat/bku106. Epub 2014 Oct 8.
- Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Eur Respir J. 1993 Mar;6 Suppl 16:5-40. doi: 10.1183/09041950.005s1693. No abstract available.
- Ray A, Raundhal M, Oriss TB, Ray P, Wenzel SE. Current concepts of severe asthma. J Clin Invest. 2016 Jul 1;126(7):2394-403. doi: 10.1172/JCI84144. Epub 2016 Jul 1.
- Ribot M, Polito A, Grassin-Delyle S, Annane D, Alvarez JC. Human plasma quantification of fludrocortisone using liquid chromatography coupled with atmospheric pressure chemical ionization mass spectrometry after low-dosage administration. Clin Chim Acta. 2013 May;420:109-13. doi: 10.1016/j.cca.2012.11.026. Epub 2012 Dec 7.
- Ricard F, Abe E, Duverneuil-Mayer C, Charlier P, de la Grandmaison G, Alvarez JC. Measurement of atropine and scopolamine in hair by LC-MS/MS after Datura stramonium chronic exposure. Forensic Sci Int. 2012 Nov 30;223(1-3):256-60. doi: 10.1016/j.forsciint.2012.09.015. Epub 2012 Oct 22.
- Roberts JK, Cook SF, Stockmann C, Rollins DE, Wilkins DG, Sherwin CM. A Population Pharmacokinetic Analysis of Dextroamphetamine in the Plasma and Hair of Healthy Adults. Clin Drug Investig. 2015 Oct;35(10):633-43. doi: 10.1007/s40261-015-0323-5.
- Rohrich J, Zorntlein S, Potsch L, Skopp G, Becker J. Effect of the shampoo Ultra Clean on drug concentrations in human hair. Int J Legal Med. 2000;113(2):102-6. doi: 10.1007/pl00007707.
- Rollins DE, Wilkins DG, Krueger GG, Augsburger MP, Mizuno A, O'Neal C, Borges CR, Slawson MH. The effect of hair color on the incorporation of codeine into human hair. J Anal Toxicol. 2003 Nov-Dec;27(8):545-51. doi: 10.1093/jat/27.8.545.
- Baque CS, Zhou J, Gu W, Collaudin C, Kravtchenko S, Kempf JY, Saint-Leger D. Relationships between hair growth rate and morphological parameters of human straight hair: a same law above ethnical origins? Int J Cosmet Sci. 2012 Apr;34(2):111-6. doi: 10.1111/j.1468-2494.2011.00687.x. Epub 2011 Oct 21.
- Salomone A, Tsanaclis L, Agius R, Kintz P, Baumgartner MR. European guidelines for workplace drug and alcohol testing in hair. Drug Test Anal. 2016 Oct;8(10):996-1004. doi: 10.1002/dta.1999. Epub 2016 Jul 12.
- Sardela VF, Deventer K, Pereira HM, de Aquino Neto FR, Van Eenoo P. Development and validation of a ultra high performance liquid chromatography-tandem mass spectrometric method for the direct detection of formoterol in human urine. J Pharm Biomed Anal. 2012 Nov;70:471-5. doi: 10.1016/j.jpba.2012.06.042. Epub 2012 Jul 7.
- Skopp G, Potsch L, Moeller MR. On cosmetically treated hair--aspects and pitfalls of interpretation. Forensic Sci Int. 1997 Jan 17;84(1-3):43-52. doi: 10.1016/s0379-0738(96)02047-6.
- Streel B, Cahay B, Klinkenberg R. Using total error concept for the validation of a liquid chromatography-tandem mass spectrometry method for the determination of budesonide epimers in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Aug 1;877(23):2290-300. doi: 10.1016/j.jchromb.2009.02.004. Epub 2009 Feb 11.
- Sullivan SD, Rasouliyan L, Russo PA, Kamath T, Chipps BE; TENOR Study Group. Extent, patterns, and burden of uncontrolled disease in severe or difficult-to-treat asthma. Allergy. 2007 Feb;62(2):126-33. doi: 10.1111/j.1398-9995.2006.01254.x.
- Szeitz A, Manji J, Riggs KW, Thamboo A, Javer AR. Validated assay for the simultaneous determination of cortisol and budesonide in human plasma using ultra high performance liquid chromatography-tandem mass spectrometry. J Pharm Biomed Anal. 2014 Mar;90:198-206. doi: 10.1016/j.jpba.2013.12.006. Epub 2013 Dec 16.
- Taylor RL, Grebe SK, Singh RJ. Quantitative, highly sensitive liquid chromatography-tandem mass spectrometry method for detection of synthetic corticosteroids. Clin Chem. 2004 Dec;50(12):2345-52. doi: 10.1373/clinchem.2004.033605. Epub 2004 Oct 14.
- Thevis M, Opfermann G, Schanzer W. Liquid chromatography/electrospray ionization tandem mass spectrometric screening and confirmation methods for beta2-agonists in human or equine urine. J Mass Spectrom. 2003 Nov;38(11):1197-206. doi: 10.1002/jms.542.
- Thomas A, Geyer H, Schanzer W, Crone C, Kellmann M, Moehring T, Thevis M. Sensitive determination of prohibited drugs in dried blood spots (DBS) for doping controls by means of a benchtop quadrupole/Orbitrap mass spectrometer. Anal Bioanal Chem. 2012 May;403(5):1279-89. doi: 10.1007/s00216-011-5655-2. Epub 2012 Jan 10.
- Thorsson L, Edsbacker S, Conradson TB. Lung deposition of budesonide from Turbuhaler is twice that from a pressurized metered-dose inhaler P-MDI. Eur Respir J. 1994 Oct;7(10):1839-44. doi: 10.1183/09031936.94.07101839.
- Tosi A, Misciali C, Piraccini BM, Peluso AM, Bardazzi F. Drug-induced hair loss and hair growth. Incidence, management and avoidance. Drug Saf. 1994 Apr;10(4):310-7. doi: 10.2165/00002018-199410040-00005.
- Tsanaclis L, Nutt J, Bagley K, Bevan S, Wicks J. Differentiation between consumption and external contamination when testing for cocaine and cannabis in hair samples. Drug Test Anal. 2014 Jun;6 Suppl 1:37-41. doi: 10.1002/dta.1623.
- van den Brink KI, Boorsma M, Staal-van den Brekel AJ, Edsbacker S, Wouters EF, Thorsson L. Evidence of the in vivo esterification of budesonide in human airways. Br J Clin Pharmacol. 2008 Jul;66(1):27-35. doi: 10.1111/j.1365-2125.2008.03164.x. Epub 2008 Apr 1.
- Van Neste D. Thickness, medullation and growth rate of female scalp hair are subject to significant variation according to pigmentation and scalp location during ageing. Eur J Dermatol. 2004 Jan-Feb;14(1):28-32.
- Van Neste D. Why care about linear hair growth rates (LHGR)? a study using in vivo imaging and computer assisted image analysis after manual processing (CAIAMP) in unaffected male controls and men with male pattern hair loss (MPHL). Eur J Dermatol. 2014 Sep-Oct;24(5):568-76. doi: 10.1684/ejd.2014.2428.
- Van Neste DJ, Rushton DH. Gender differences in scalp hair growth rates are maintained but reduced in pattern hair loss compared to controls. Skin Res Technol. 2016 Aug;22(3):363-9. doi: 10.1111/srt.12274. Epub 2015 Nov 3.
- van Zyl GU, van Mens TE, McIlleron H, Zeier M, Nachega JB, Decloedt E, Malavazzi C, Smith P, Huang Y, van der Merwe L, Gandhi M, Maartens G. Low lopinavir plasma or hair concentrations explain second-line protease inhibitor failures in a resource-limited setting. J Acquir Immune Defic Syndr. 2011 Apr;56(4):333-9. doi: 10.1097/QAI.0b013e31820dc0cc.
- Wang Y, Tang Y, Moellmann H, Hochhaus G. Simultaneous quantification of budesonide and its two metabolites, 6beta-hydroxybudesonide and 16alpha-hydroxyprednisolone, in human plasma by liquid chromatography negative electrospray ionization tandem mass spectrometry. Biomed Chromatogr. 2003 Mar-Apr;17(2-3):158-64. doi: 10.1002/bmc.233.
- Wenzel SE. Complex phenotypes in asthma: current definitions. Pulm Pharmacol Ther. 2013 Dec;26(6):710-5. doi: 10.1016/j.pupt.2013.07.003. Epub 2013 Jul 20.
- Williams J, Patsalos PN, Mei Z, Schapel G, Wilson JF, Richens A. Relation between dosage of carbamazepine and concentration in hair and plasma samples from a compliant inpatient epileptic population. Ther Drug Monit. 2001 Feb;23(1):15-20. doi: 10.1097/00007691-200102000-00004.
- Yegles M, Marson Y, Wennig R. Influence of bleaching on stability of benzodiazepines in hair. Forensic Sci Int. 2000 Jan 10;107(1-3):87-92. doi: 10.1016/s0379-0738(99)00152-8.
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