Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-04-17 @ 10:54 AM
Study NCT ID:
NCT02273661
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2014-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001229', 'term': 'Aspergillosis, Allergic Bronchopulmonary'}], 'ancestors': [{'id': 'D055732', 'term': 'Pulmonary Aspergillosis'}, {'id': 'D001228', 'term': 'Aspergillosis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C068538', 'term': 'liposomal amphotericin B'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2014-10-22', 'studyFirstSubmitQcDate': '2014-10-22', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'occurrence of first severe clinical exacerbation', 'timeFrame': 'within 24 months following the attack treatment,', 'description': '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:\n\n1. -increased inhalation treatments (inhaled bronchodilators and / or corticosteroids)\n\n * and / or initiation of systemic corticosteroid treatment\n * and / or hospitalization\n2. AND persisting for more than 7 days.'}]}, 'conditionsModule': {'conditions': ['Allergic Bronchopulmonary Aspergillosis']}, 'referencesModule': {'references': [{'pmid': '38387646', 'type': 'DERIVED', 'citation': 'Godet C, Brun AL, Couturaud F, Laurent F, Frat JP, Marchand-Adam S, Gagnadoux F, Blanchard E, Taille C, Philippe B, Hirschi S, Andrejak C, Bourdin A, Chenivesse C, Dominique S, Mangiapan G, Murris-Espin M, Riviere F, Garcia G, Blanc FX, Goupil F, Bergeron A, Flament T, Priou P, Mal H, de Keizer J, Ragot S, Cadranel J; NebuLamB Study Group and GREPI Network. CT Imaging Assessment of Response to Treatment in Allergic Bronchopulmonary Aspergillosis in Adults With Bronchial Asthma. Chest. 2024 Jun;165(6):1307-1318. doi: 10.1016/j.chest.2024.02.026. Epub 2024 Feb 20.'}, {'pmid': '34764182', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll patients with ABPA justifying an attack treatment with corticosteroids and itraconazole and combining the following criteria:\n\n1. 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.\n2. 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.\n3. After informing and obtaining consent signed.\n\nExclusion Criteria:\n\n* 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,\n* Patient with cystic fibrosis\n* Patient with a contra-indication to itraconazole\n* Intolerance to β2 -agonists\n* Known hypersensitivity to liposomal amphotericin B or any other component\n* 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 )\n* severe renal function impairment (creatinine clearance enf to 30 ml/min)\n* 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)\n* patient with anti IgE- monoclonal antibody for less than 4 months or with current complications related to previous treatment with anti IgE- monoclonal antibody -\n* Ventricular dysfunction demonstrated such as congestive heart failure or a history of congestive heart failure\n* Simple aspergilloma, chronic pulmonary aspergillosis, invasive pulmonary aspergillosis\n* Respiratory infection aggravating asthma or ABPA"}, 'identificationModule': {'nctId': 'NCT02273661', 'acronym': 'NEBULAMB', 'briefTitle': 'Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded).', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded)', 'orgStudyIdInfo': {'id': 'NEBULAMB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'An aerosol of isotonic saline x 1/ week will be administered during 6 months', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ambisome', 'description': 'An aerosol of Liposomal Amphotericin B (Ambisome®) at 25 mg x 1/ week will be administered during 6 months', 'interventionNames': ['Drug: Liposomal amphotericin B (Ambisome®)']}], 'interventions': [{'name': 'Liposomal amphotericin B (Ambisome®)', 'type': 'DRUG', 'description': 'An aerosol of Liposomal Amphotericin B (Ambisome®) at 25 mg x 1/ week will be administered during 6 months', 'armGroupLabels': ['Ambisome']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'An aerosol of isotonic saline x 1/ week will be administered during 6 months', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'Chu de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}