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

Primary Purpose

Allergic Bronchopulmonary Aspergillosis

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Liposomal amphotericin B (Ambisome®)

placebo

About this trial

This is an interventional treatment trial for Allergic Bronchopulmonary Aspergillosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chu de Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Ambisome

Arm Description

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

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

Outcomes

Primary Outcome Measures

occurrence of first severe clinical exacerbation

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02273661

First Posted

October 22, 2014

Last Updated

June 8, 2020

Sponsor

Poitiers University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02273661

Brief Title

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

Acronym

NEBULAMB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

November 19, 2014 (Actual)

Primary Completion Date

June 28, 2019 (Actual)

Study Completion Date

June 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poitiers University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Bronchopulmonary Aspergillosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

174 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Ambisome

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Liposomal amphotericin B (Ambisome®)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

occurrence of first severe clinical exacerbation

Description

Time Frame

within 24 months following the attack treatment,

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Chu de Poitiers

City

Poitiers

ZIP/Postal Code

86000

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

34764182

Citation

Godet C, Couturaud F, Marchand-Adam S, Pison C, Gagnadoux F, Blanchard E, Taille C, Philippe B, Hirschi S, Andrejak C, Bourdin A, Chenivesse C, Dominique S, Bassinet L, Murris-Espin M, Riviere F, Garcia G, Caillaud D, Blanc FX, Goupil F, Bergeron A, Gondouin A, Frat JP, Flament T, Camara B, Priou P, Brun AL, Laurent F, Ragot S, Cadranel J; NebuLamB study group and GREPI network; Godet C, Couturaud F, Cadranel J, Frat JP, Brun AL, Laurent F, Marchand-Adam S, Pison C, Gagnadoux F, Blanchard E, Taille C, Philippe B, Hirschi S, Andrejak C, Chenivesse C, Dominique S, Bassinet L, Murris-Espin M, Riviere F, Garcia G, Caillaud D, Blanc FX, Goupil F, Gondouin A, Flament T, Camara B, Priou P, Ragot S. Nebulised liposomal amphotericin-B as maintenance therapy in allergic bronchopulmonary aspergillosis: a randomised, multicentre trial. Eur Respir J. 2022 Jun 16;59(6):2102218. doi: 10.1183/13993003.02218-2021. Print 2022 Jun.

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

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