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
Conditions
Interventions
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
Sponsors
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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. | — |
Countries
Italy
Outcome results
None listed