Clinical trials in rare diseases: therapeutic alternative to the use of oral corticosteroids in patients with cystic fibrosis underwent double lung transplantation.

• Register: EUCTR
• Last refreshed on: 27 January 2014
• Main ID: EUCTR2011-000130-11-IT
• Date of registration: 05/03/2012
• Prospective Registration: No
• Primary sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
• Public title: Clinical trials in rare diseases: therapeutic alternative to the use of oral corticosteroids in patients with cystic fibrosis underwent double lung transplantation.
• Scientific title: Clinical trials in rare diseases: therapeutic alternative to the use of oral corticosteroids in patients with cystic fibrosis underwent double lung transplantation.
• Date of first enrolment: 25/07/2011
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000130-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes 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: no Placebo: no Other: yes Other specify the comparator: - same IMP used at different dosage Number of treatment arms in the trial: 1

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion criteria:
• Diagnosis documented FC • Double-lung transplantation at least 3 months • Age = 12 years with no upper limits • Both sexes • Good compliance
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
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) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Bulkholderia cepacia colonization and atypical mycobacteria Noncompliant • Subject to usual therapy • Pregnancy • Changes in therapy during the 30 days prior • episodes of acute rejection in the 30 days prior to the start of treatment, for which it was required intravenous or oral corticosteroid therapy • Patients with liver problems and / or kidney showing values of AST, ALT, or creatinine> 2 times the normal value


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Double lung transplantation in patients with Cystic Fibrosis
MedDRA version: 14.1 Level: PT Classification code 10011763 Term: Cystic fibrosis lung System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1 Level: PT Classification code 10025127 Term: Lung transplant System Organ Class: 10042613 - Surgical and medical procedures

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Product Name: Dexamethasone sodium phosphate 250 mg/10 ml solution
Product Code: NA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Dexamethasone
Concentration unit: mg/ml milligram(s)/millilitre
Concentration number: 500-

Primary Outcome(s)

Secondary Objective: To assess the safety of the drug. Evaluate the reduction of pulmonary infections and / or invasive. Assess the reduction in the incidence of failure or possibly worsening osteoporosis / opsteopenia background to LTX. Assess the reduction of occurrence or worsening of diabetes may be non-existing at LTX. Evaluate the reduction in the incidence of hypertension. Assessing the quality of life.

Primary end point(s): Check to see if low doses of Dex-21-P (10 mg / month) encapsulated in RBCs in patients with CF and underwent LTX compared to traditional oral dosing, are able to prevent acute rejection / chronic.

Main Objective: Reducing the intake of oral steroids in patients with CF and underwent LTX. One wonders whether, compared to the classic dose of 25 mg / day for the first 3 months post-LTX and then 20 mg / day for 1 year post-LTX, low-dose dexamethasone (10 mg / month) encapsulated in RBCs are able to prevent acute/chronic rejection and reduce side effects associated with use of oral steroids

Secondary ID(s)

EryDexFCTx1.0