AsthmaCorticHairNCT03691961
Corticosteroids/β2-agonists in Hair in Asthmatic Patients (CorticHair)
A study testing Hair sampling and Hair's drug concentrations in people with Asthma, run by Hopital Foch at 1 site in France.
Trial summary
This feasibility study will be open-label with two dose groups: patients receiving budesonide/formoterol Turbuhaler® at a total daily dose [400 to 800 µg[ (group 1) and patients receiving a total daily dose ≥800 µg/day (group 2) to investigate whether there is a relationship between dose and hair concentration. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Asthma
- What is being tested?
- Hair sampling and Hair's drug concentrations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2018to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provision of informed consent prior to any study specific procedure
- Outpatients with asthma, of either gender, aged ≥18 and <50 years at visit 1
- Controlled or partly controlled asthma according to the Global Initiative for Asthma (GINA) guideline
- Receiving a constant daily dose ≥400 µg budesonide of budesonide/formoterol Turbuhaler® for more than 2 months
- No treatment step-down is planned in the 3 next months
- ACQ (Asthma Control Questionnaire) score ≤ 1.50
- Patient with healthcare insurance
Who cannot join
- Pregnant women or women wishing to become pregnant in the next 3 months
- Patients with body mass index (BMI) <18 or >30
- Patients with known kidney or liver disease (creatinine clearance < 60 mL/min/1.73 m² or alanine aminotransferase (ALAT) > 5N)
- Smokers or former smokers < 3 years
- Patients with simultaneous asthma and chronic obstructive pulmonary disease (COPD) (or defined as having asthma-COPD overlap syndrome)
- Other budesonide- or formoterol-containing drugs (e.g Foradil®, Rhinocort®, Mikicort®, Entocort®…)
Show all 13Show fewer
- CYP3A4 inducers (systemic corticosteroid, rifampicin, phenobarbital, carbamazepine…)
- CYP3A4 inhibitors (macrolides, azole antifungals, valproic acid, amiodarone, fluoxetine)
- Hair treatment (coloration, bleaching, perming…)
- Hairless patients, hair implants or hair extensions
- Length of hair from the vertex posterior region < 5 cm or planning to cut hair from this region shorter than 5 cm in the next 4 months
- Patient deprived of liberty by judicial or administrative decision
- Major protected by law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Drug Monitoring of Corticosteroids/β2-agonists in Hair in Asthmatic Patients: an Open-label Feasibility Study
This feasibility study will be open-label with two dose groups: patients receiving budesonide/formoterol Turbuhaler® at a total daily dose [400 to 800 µg[ (group 1) and patients receiving a total daily dose ≥800 µg/day (group 2) to investigate whether there is a relationship between dose and hair concentration.
The objective of this feasibility study is to determine if the product administered to the patient is detectable and quantifiable in hair in order to have a mean to monitor adherence to the treatment. This study does not in any way evaluate the efficacy or safety of the medicinal product, which will be used in accordance with its marketing authorization.
Read the detailed description
Asthma affects 3-10% of the European population and is a heterogeneous disease in its clinical manifestations and also in its response to treatment. Since therapy is often started at young age and given over many years, with adjustments made on disease control, long-term adherence and efficacy are particular concerns.
Adherence to inhaled controller medications is a major challenge to obtain disease control and to avoid serious asthma flare-ups or unnecessary treatment stepping up. In addition to adherence concerns, poor asthma control may also be the consequence of a poor inhalation technique and the resulting insufficient drug exposure.
To overcome adherence issues, patients are encouraged to self-manage their disease and the use of new technologies such as inhaler reminders, electronic devices and/or smartphone applications may be helpful. Although there is a margin to improve and monitor adherence, assessing the efficiency of the inhalation technique in daily routine and its consequences in terms of drug exposure is much harder.
The traditional monitoring of pharmacological therapies involves therapeutic drug monitoring, i.e. the measure of drug concentration in plasma. But drugs concentration in plasma most only reflect the quantity of drug in the body in the last 24-48 hrs only. Hence, therapeutic drug monitoring is not used for inhaled asthma treatments, in part because of the limited interest in assessing only a 24-48 hrs exposure and of the very low plasma concentrations which are very challenging to measure.
Since drugs present in the bloodstream also reach and stay in the forming hair where their concentrations can be measured and interpreted as an overall chronic exposure, hair analysis could become a valuable tool in the monitoring of inhaled asthma treatments, with the use of very specific mass spectrometry techniques and of the most sensitive last-generation mass spectrometers.
- Conditions
- Asthma
- Being tested
- Hair sampling, Hair's drug concentrations
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair samplingOther
After 4 months of treatment, a strand of hair from the vertex posterior region of the scalp about the width of a thin pencil and with a length equal to or greater than 3 cm will be cut.
Hair's drug concentrationsDiagnostic test
The hair's concentrations of budesonide/formoterol is analysed with mass spectrometry.
| Study group | Role | What they receive |
|---|---|---|
| Medium dose of Symbicort Turbuhaler® | Experimental | The population is asthmatic patients meeting the inclusion and exclusion criteria for whom the optimized total daily dose to treat the disease is ≥400 to 800 µg budesonide of budesonide/formoterol Symbicort Turbuhaler®.
Hair sampling after 4 months treatment.
Analysis of hair's drug concentrations. Receives: Other: Hair sampling; Diagnostic Test: Hair's drug concentrations |
| High dose of Symbicort Turbuhaler® | Experimental | The population is asthmatic patients meeting the inclusion and exclusion criteria for whom the optimized total daily dose to treat the disease is ≥800 µg budesonide of budesonide/formoterol Symbicort TurbuhalerTurbuhaler®.
Hair sampling after 4 months treatment.
Analysis of hair's drug concentrations. Receives: Other: Hair sampling; Diagnostic Test: Hair's drug concentrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Budesonide/formoterol hair concentrations (active substance and metabolites)
After 4 months of treatment, the hair's concentrations of budesonide/formoterol is analyzed with mass spectrometry.
Measured: 4 months
Secondary outcomes (3)
Budesonide/formoterol concentration in three 1-cm hair segments (active substance and metabolites)
After 4 months of treatment, the concentrations of budesonide/formoterol in three 1-cm hair segments is analyzed with mass spectrometry.
Measured: 4 months
Budesonide/formoterol hair's concentration compared to the daily observance.
Patient cumulative dose is estimated from daily observance recorded by the patient in the observance record.
Measured: 4 months
Correlation between budesonide/formoterol hair concentrations, forced expiratory volume in 1 second (FEV1), and asthma control questionnaire (ACQ)
FEV1 (measured according to a standardized spirometry technique), and ACQ (patients with a score below 1.0 will have adequately controlled asthma and above 1.0 their asthma will not be well controlled) are collected at the inclusion visit and the 4 months visit
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start20 Sep 2018
- Primary completion20 Jul 2023 (estimated)
- Study completion20 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (102)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Half of the patients is enrolled in each group according to the individual dose decided by the clinician in charge as the optimal dose to treat the disease. The optimized dose to treat the disease is decided independently of the participation to the study.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stanislas Grassin-Delyle, Dr, Study director, University Versailles Saint Quentin / Foch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691961
- Sponsor's protocol ID
- 2017047F
- Acronym
- CorticHair
- Status last verified
- Aug 2022
- First submitted
- 28 Sep 2018
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23510684Alonso 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.
PubMed 16443746Alvarez 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.
PubMed 26226314Alvarez 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.
PubMed 21185793Auchus 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.
PubMed 24837046Baxi 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.
PubMed 26053176Bevalot 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.
PubMed 10821409Borges 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.
PubMed 21233029Buscher 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.
PubMed 22169057Capron 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.
PubMed 26657979Chalmers 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.
PubMed 11867826Chèze, 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.
PubMed 21916889Cirimele 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.
PubMed 10689588Cirimele 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.
PubMed 10369335
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Monitoring of Corticosteroids/β2-agonists in Hair in Asthmatic Patients: an Open-label Feasibility Study
- ClinicalTrials.gov ID
- NCT03691961
- Acronym / sponsor ID
- CorticHair / 2017047F
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 20 Jul 2023 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility study will be open-label with two dose groups: patients receiving budesonide/formoterol Turbuhaler® at a total daily dose [400 to 800 µg[ (group 1) and patients receiving a total daily dose ≥800 µg/day (group 2) to investigate whether there is a relationship between dose and hair concentration.
The objective of this feasibility study is to determine if the product administered to the patient is detectable and quantifiable in hair in order to have a mean to monitor adherence to the treatment. This study does not in any way evaluate the efficacy or safety of the medicinal product, which will be used in accordance with its marketing authorization.
Detailed description
Asthma affects 3-10% of the European population and is a heterogeneous disease in its clinical manifestations and also in its response to treatment. Since therapy is often started at young age and given over many years, with adjustments made on disease control, long-term adherence and efficacy are particular concerns.
Adherence to inhaled controller medications is a major challenge to obtain disease control and to avoid serious asthma flare-ups or unnecessary treatment stepping up. In addition to adherence concerns, poor asthma control may also be the consequence of a poor inhalation technique and the resulting insufficient drug exposure.
To overcome adherence issues, patients are encouraged to self-manage their disease and the use of new technologies such as inhaler reminders, electronic devices and/or smartphone applications may be helpful. Although there is a margin to improve and monitor adherence, assessing the efficiency of the inhalation technique in daily routine and its consequences in terms of drug exposure is much harder.
The traditional monitoring of pharmacological therapies involves therapeutic drug monitoring, i.e. the measure of drug concentration in plasma. But drugs concentration in plasma most only reflect the quantity of drug in the body in the last 24-48 hrs only. Hence, therapeutic drug monitoring is not used for inhaled asthma treatments, in part because of the limited interest in assessing only a 24-48 hrs exposure and of the very low plasma concentrations which are very challenging to measure.
Since drugs present in the bloodstream also reach and stay in the forming hair where their concentrations can be measured and interpreted as an overall chronic exposure, hair analysis could become a valuable tool in the monitoring of inhaled asthma treatments, with the use of very specific mass spectrometry techniques and of the most sensitive last-generation mass spectrometers.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Half of the patients is enrolled in each group according to the individual dose decided by the clinician in charge as the optimal dose to treat the disease. The optimized dose to treat the disease is decided independently of the participation to the study.
| Arm | Type | Receives |
|---|---|---|
| Medium dose of Symbicort Turbuhaler® | Experimental | Other: Hair sampling, Diagnostic Test: Hair's drug concentrationsThe population is asthmatic patients meeting the inclusion and exclusion criteria for whom the optimized total daily dose to treat the disease is ≥400 to 800 µg budesonide of budesonide/formoterol Symbicort Turbuhaler®. Hair sampling after 4 months treatment. Analysis of hair's drug concentrations. |
| High dose of Symbicort Turbuhaler® | Experimental | Other: Hair sampling, Diagnostic Test: Hair's drug concentrationsThe population is asthmatic patients meeting the inclusion and exclusion criteria for whom the optimized total daily dose to treat the disease is ≥800 µg budesonide of budesonide/formoterol Symbicort TurbuhalerTurbuhaler®. Hair sampling after 4 months treatment. Analysis of hair's drug concentrations. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provision of informed consent prior to any study specific procedure
- Outpatients with asthma, of either gender, aged ≥18 and <50 years at visit 1
- Controlled or partly controlled asthma according to the Global Initiative for Asthma (GINA) guideline
- Receiving a constant daily dose ≥400 µg budesonide of budesonide/formoterol Turbuhaler® for more than 2 months
- No treatment step-down is planned in the 3 next months
Key exclusion criteria (13 listed)
- Pregnant women or women wishing to become pregnant in the next 3 months
- Patients with body mass index (BMI) <18 or >30
- Patients with known kidney or liver disease (creatinine clearance < 60 mL/min/1.73 m² or alanine aminotransferase (ALAT) > 5N)
- Smokers or former smokers < 3 years
- Patients with simultaneous asthma and chronic obstructive pulmonary disease (COPD) (or defined as having asthma-COPD overlap syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hair samplingAfter 4 months of treatment, a strand of hair from the vertex posterior region of the scalp about the width of a thin pencil and with a length equal to or greater than 3 cm will be cut. | Other | High dose of Symbicort Turbuhaler®, Medium dose of Symbicort Turbuhaler® |
| Hair's drug concentrationsThe hair's concentrations of budesonide/formoterol is analysed with mass spectrometry. | Diagnostic test | High dose of Symbicort Turbuhaler®, Medium dose of Symbicort Turbuhaler® |
Primary outcome
Budesonide/formoterol hair concentrations (active substance and metabolites)
Time frame: 4 months
After 4 months of treatment, the hair's concentrations of budesonide/formoterol is analyzed with mass spectrometry.
3 secondary outcomes
Budesonide/formoterol concentration in three 1-cm hair segments (active substance and metabolites)
Time frame: 4 months
Budesonide/formoterol hair's concentration compared to the daily observance.
Time frame: 4 months
Correlation between budesonide/formoterol hair concentrations, forced expiratory volume in 1 second (FEV1), and asthma control questionnaire (ACQ)
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Background: PubMed 23510684Al-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.
- Background: PubMed 16443746Alonso 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.
- Background: PubMed 26226314Alvarez 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.
- Background: PubMed 21185793Alvarez 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.
- Background: PubMed 24837046Auchus 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.
- Background: PubMed 26053176Baxi 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.
- Background: PubMed 10821409Bevalot 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.
- Background: PubMed 21233029Borges 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.
- Background: PubMed 22169057Buscher 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.
- Background: PubMed 26657979Capron 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.
- Background: PubMed 11867826Chalmers 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.
- BackgroundChèze, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanislas Grassin-Delyle, Dr study director
University Versailles Saint Quentin / Foch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hair sampling and Hair's drug concentrations in people with Asthma, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Budesonide/formoterol hair concentrations (active substance and metabolites) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691961, which also lists 102 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.