Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis (ABPA) MedDRA version: 9.1 Level: SOC Classification code 10021881 MedDRA version: 9.1 Level: PT Classification code 10011762
Conditions
Interventions
Trade Name: ABELCET
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Amphotericin B
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentra
Sponsors
AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males/females age > = 12 years. 2. Cystic Fibrosis diagnosed by either gene profiling and/or sweat test. 3. ABPA diagnosis defined as: i) Acute or sub-acute clinical deterioration (cough, wheeze, exercise intolerance, exercise-induced asthma, change in pulmonary function, or increased sputum production) not attributable to another etiology. ii) Total serum IgE concentration of >500 IU/mL (1200 ng/mL). iii) presence of IgE antibody to A. fumigatus. iv) One of the following: a) presence of precipitans to A.fumigatus or b) new or recent abnormalities on chest radiography (infiltrates or mucus plugging) or chest CT (bronchiectasis) that has not cleared with antibiotics and standard physiotherapy. 4. Total serum IgE level of > 500 IU/ml (will be measured locally at Screening Visit). 5. Patients who present with an acute episode of ABPA, either as a first presentation or as a recurrence, and who were taking a maximum dose of prednisolone of 20mg/day (or equivalent) 6. FEV1 > = 40% 7. Suitable contraceptive measure 8. Prior to administration of any study procedures, eligible patients (and parents for patients below age 18) must provide written informed consent Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of cancer in the past 10 years (except surgically-cured basal cell or squamous cell skin cancer). 2. Any previous history of anaphylaxis. 3. Any other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. 4. Pregnant and lactating women. 5. Lung or other transplant or in a transplantation list. 6. Participation in any clinical trial within four (4) weeks prior to initial dosing. 7. Significant illness other than CF/ABPA within two (2) weeks prior to initial dosing. 8. Patients who are known to be positive for chronic atypical Mycobacteria and Burkholderia cepacia including subspecies. 9. Subjects must be able to communicate well with the investigator; understand and comply with the requirements of the study; and understand and sign the written informed consent (parental consent and assent for minors, if applicable). 10. medical history of kidney problems defined like creatinine values equal the double of normal value 11. intake of itraconazole in the precedent 15 days before the screening visit. 12. steroidal therapy > 20 mg/die
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the tolerability of Amphotericin B lipid complex (Abelcet) by aerosol with a special focus on kidney involvement;Secondary Objective: To evaluate the decrease of total and specific IgE values at the end of the treatment (at the 4th and 8th week of treatment) - To evaluate the FEV1 variation - To evaluate the quality of life;Primary end point(s): Appearance of an adverse event defined like an increase of creatinine between the beginning and the end of the treatment | — |
Countries
Italy
Outcome results
None listed