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Completed

NCT Number: NCT02273661

Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded).

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 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

Treatment and study plan

Liposomal amphotericin B (AmBisome®)

Drug

An aerosol of Liposomal Amphotericin B (Ambisome®) at 25 mg x 1/ week will be administered during 6 months

Placebo

Drug

An aerosol of isotonic saline x 1/ week will be administered during 6 months

Primary outcomes

  1. occurrence of first severe clinical exacerbation

    Time frame: within 24 months following the attack treatment,

    Occurrence of severe clinical exacerbation within 24 months following attack treatment, defined by the onset or worsening of dyspnea aggravating the baseline condition that justified:

    • -increased inhalation treatments (inhaled bronchodilators and / or corticosteroids)
    • and / or initiation of systemic corticosteroid treatment
    • and / or hospitalization
    • AND persisting for more than 7 days.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded)

Acronym: NEBULAMB

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 24, 2014
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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