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 @ 12:32 PM
Ignite Modification Date:
2025-12-24 @ 12:32 PM
NCT ID:
NCT02273661
Eligibility Criteria:
Inclusion Criteria:
All patients with ABPA justifying an attack treatment with corticosteroids and itraconazole and combining the following criteria:
1. atopic subject or a history of asthma , history of total Immunoglobin E (IgE)\> 417 kU / L (or \> 210 kU / L with a clear worsening) of a known ABPA), specific Immunoglobin E against Aspergillus fumigatus positive ( \>0.35 KUA/L) or positive skin tests.
2. associated with two other of the following criteria: documentation of precipitating antibodies or Immunoglobulin G positive to Aspergillus fumigatus, of radiological infiltrates associated with ABPA (transitional / persistent / bronchial dilation), of blood eosinophilia \> 500 elements/mm3.
3. After informing and obtaining consent signed.
Exclusion Criteria:
* Women of childbearing age who do not have an effective contraception for at least 12 first months of the study( 10 months + 2 months of treatment washout) pregnant or lactating women,
* Patient with cystic fibrosis
* Patient with a contra-indication to itraconazole
* Intolerance to β2 -agonists
* Known hypersensitivity to liposomal amphotericin B or any other component
* Laboratory abnormalities: significant abnormalities of platelet blood count , liver function tests (SGPT, SGOT(serum glutamate oxaloacetate transaminase) , total bilirubin \> 5 times the upper limit of the normal range )
* severe renal function impairment (creatinine clearance enf to 30 ml/min)
* Concomitant use of one or more of the following treatments: Alfuzosine, alcaloïdes de l'ergot de seigle vasoconstricteur, aliskiren, astemizole, atorvastatine, avanafil, association Ombitasvir and Paritaprevir, Bepridil, Cisaprid, Dabigatran, dapoxetin, domperidon, dronedaron, Eplerenone, Halofantrin, Ivabradin, Lomitapid, lurasidon, Millepertuis, mizolastin, Pimozid,Quétiapin, quinidin, Ranolazine, ritonavir, Sertindole, sildénafil, simvastatin, sirolimus, Sultoprid, Terfenadine, ticagrelor, triazolam Vardénafil (in men over than 75)
* patient with anti IgE- monoclonal antibody for less than 4 months or with current complications related to previous treatment with anti IgE- monoclonal antibody -
* Ventricular dysfunction demonstrated such as congestive heart failure or a history of congestive heart failure
* Simple aspergilloma, chronic pulmonary aspergillosis, invasive pulmonary aspergillosis
* Respiratory infection aggravating asthma or ABPA
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02273661
Study Brief:
Protocol Section:
NCT02273661