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

Chiesi Farmaceutici S.p.A.92 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cystic Fibrosis

Eligibility

Sex: ALLMin age: 10 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (1)

U.O. Azienda Ospedaliera

Verona, Veneto, Italy

Outcomes

Primary Outcomes

To describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients

Time frame: 5 years

Secondary Outcomes

To identify clinical parameters or treatments correlated to FEV1 maintenance in two cohorts of cystic fibrosis patients

Time frame: 5 years

To evaluate the number of patients with Pseudomonas Aeruginosa infection during observational period

Time frame: 5 years

To describe length of time without Pseudomonas A. infection in non-colonized patients during observational period.

Time frame: 5 years

Data from ClinicalTrials.gov

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