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Trial record 59 of 201 for:    aspergillosis

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

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ClinicalTrials.gov Identifier: NCT02273661
Recruitment Status : Active, not recruiting
First Posted : October 24, 2014
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

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.

Condition or disease Intervention/treatment Phase
Allergic Bronchopulmonary Aspergillosis Drug: Liposomal amphotericin B (Ambisome®) Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded)
Actual Study Start Date : November 19, 2014
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019


Arm Intervention/treatment
Placebo Comparator: Control
An aerosol of isotonic saline x 1/ week will be administered during 6 months
Drug: placebo
An aerosol of isotonic saline x 1/ week will be administered during 6 months

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




Primary Outcome Measures :
  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:

    1. -increased inhalation treatments (inhaled bronchodilators and / or corticosteroids)

      • and / or initiation of systemic corticosteroid treatment
      • and / or hospitalization
    2. AND persisting for more than 7 days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273661


Locations
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France
Chu de Poitiers
Poitiers, France, 86000
Sponsors and Collaborators
Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02273661     History of Changes
Other Study ID Numbers: NEBULAMB
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Aspergillosis
Pulmonary Aspergillosis
Aspergillosis, Allergic Bronchopulmonary
Cystic Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Mycoses
Lung Diseases, Fungal
Respiratory Hypersensitivity
Respiratory Tract Infections
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Amphotericin B
Liposomal amphotericin B
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents