Corticosteroids/β2-agonists in Hair in Asthmatic Patients (CorticHair)

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追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

September 24, 2018

预计主要完成日期

January 24, 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

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.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Budesonide/formoterol concentration in three 1-cm hair segments (active substance and metabolites)[ Time Frame: 4 months ]
After 4 months of treatment, the concentrations of budesonide/formoterol in three 1-cm hair segments is analyzed with mass spectrometry.
Budesonide/formoterol hair's concentration compared to the daily observance.[ Time Frame: 4 months ]
Patient cumulative dose is estimated from daily observance recorded by the patient in the observance record.
Correlation between budesonide/formoterol hair concentrations, forced expiratory volume in 1 second (FEV1), and asthma control questionnaire (ACQ)[ Time Frame: 4 months ]
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

描述性信息

简略标题 ^ICMJE

Corticosteroids/β2-agonists in Hair in Asthmatic Patients (CorticHair)

正式标题 ^ICMJE

Therapeutic Drug Monitoring of Corticosteroids/β2-agonists in Hair in Asthmatic Patients: an Open-label Feasibility Study

简要概况

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.

详细说明

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.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Non-Randomized
干预模型: Parallel Assignment
干预模型描述: 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.
盲法: Interventional
盲法描述:
主要目的: Other

适用条件 ^ICMJE

干预项目 ^ICMJE

Other: Hair sampling
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.
Diagnostic Test: Hair's drug concentrations
The hair's concentrations of budesonide/formoterol is analysed with mass spectrometry.

研究工具

Experimental: Medium dose of Symbicort Turbuhaler®
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.
Experimental: High dose of Symbicort Turbuhaler®
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.

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

January 24, 2020

预计主要完成日期

January 24, 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - 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 Exclusion Criteria: - 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®…) - 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

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：49 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

France

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Hopital Foch

合作者 ^ICMJE

研究员 ^ICMJE

Study Director: Stanislas Grassin-Delyle, Dr University Versailles Saint Quentin / Foch Hospital

PRS 账户

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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