Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-24 @ 12:23 PM
NCT ID:
NCT03691961
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT03691961
Study Brief:
Protocol Section:
NCT03691961