Esplorative study to evaluate the tolerability of Amphotericin B lipid complex (Abelcet) by aerosol in patients with Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis (ABPA) - ND

• Conditions: Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis (ABPA); MedDRA version: 9.1Level: SOCClassification code 10021881; MedDRA version: 9.1Level: PTClassification code 10011762

• Registration Number: EUCTR2010-019194-15-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified