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

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT01651455
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-07-26
• Study First Posted: 2012-07-27
• Study Start: 2012-09
• Primary Completion: 2013-03
• Study Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-30
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients	5 years

Secondary Outcome Measures

Name	Time	Method
To evaluate the number of patients with Pseudomonas Aeruginosa infection during observational period	5 years
To identify clinical parameters or treatments correlated to FEV1 maintenance in two cohorts of cystic fibrosis patients	5 years
To describe length of time without Pseudomonas A. infection in non-colonized patients during observational period.	5 years

Trial Locations

Locations (1)

U.O. Azienda Ospedaliera; 🇮🇹 Verona, Veneto, Italy