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

August 2, 2022 updated by: Hopital Foch

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Foch Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months
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.
4 months
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 20, 2018

Primary Completion (ANTICIPATED)

July 20, 2023

Study Completion (ANTICIPATED)

July 20, 2023

Study Registration Dates

First Submitted

September 28, 2018

First Submitted That Met QC Criteria

October 1, 2018

First Posted (ACTUAL)

October 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017047F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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