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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2010-019194-15-IT |
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Date of registration:
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13/05/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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12/05/2010 |
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Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019194-15 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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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
Concentration number: 100-
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Primary Outcome(s)
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Primary end point(s): Appearance of an adverse event defined like an increase of creatinine between the beginning and the end of the treatment
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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
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Main Objective: To evaluate the tolerability of Amphotericin B lipid complex (Abelcet) by aerosol with a special focus on kidney involvement
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Secondary ID(s)
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CRCFC-ABLC003
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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