Retrospective Observational Study to Compare Cystic Fibrosis Patients in Two Decades Before and After 2000 (MAESTRALE)

Chiesi

Status: Completed

Conditions: Cystic Fibrosis

Study type: Observational

Funder types: Industry

Identifiers

NCT01651455

MAESTRALE

Details and patient eligibility

About

The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2 different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.

Full description

The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in terms of FEV1 maintenance from the age of 10 to 15 before and after 2000.

Enrollment: 92 patients

Sex: All

Ages: 10 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Cystic Fibrosis diagnosed with neo-natal screening
• Patients born between 01/01/1979 and 12/31/1984 (Cohort 1)and patients born between 01/01/1991 and 12/31/1996 (Cohort 2)
• Patients with at least 2 FEV1 yearly measurements from the age of 10 to 15

Exclusion criteria

• Patients with malignant tumor
• Patients with meconium ileus
• Patients with transplantation (pneumectomy or lobectomy)
• Patients involved in any other clinical trial
• Patients moved to another Clinical Center

Trial design

92 participants in 2 patient groups

Cohort first decade

Description:

Patients born between 01/01/1979 and 12/31/1984

Cohort second decade

Description:

Patients born between 01/01/1991 and 12/31/1996