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

• Conditions: Double lung transplantation in patients with Cystic Fibrosis; MedDRA version: 14.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 14.1Level: PTClassification code 10025127Term: Lung transplantSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-000130-11-IT
• Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-05
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

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

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

Study & Design

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