Status:
COMPLETED
Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded).
Lead Sponsor:
Poitiers University Hospital
Conditions:
Allergic Bronchopulmonary Aspergillosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Compare the incidence of severe clinical exacerbations in the treatment of ABPA, between a strategy with a maintenance treatment and a conventional strategy without antifungal maintenance therapy.
Eligibility Criteria
Inclusion
- All patients with ABPA justifying an attack treatment with corticosteroids and itraconazole and combining the following criteria:
- 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.
- 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.
- After informing and obtaining consent signed.
Exclusion
- 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
Key Trial Info
Start Date :
November 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2019
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT02273661
Start Date
November 19 2014
End Date
June 28 2019
Last Update
June 9 2020
Active Locations (1)
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1
Chu de Poitiers
Poitiers, France, 86000