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

NCT03691961 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-08-03

No results posted yet for this study

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.

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Hopital Foch

    lead OTHER

Principal Investigators

  • Stanislas Grassin-Delyle, Dr · University Versailles Saint Quentin / Foch Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2023-07-20
Completion
2023-07-20

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03691961 on ClinicalTrials.gov