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

Maintaining Lung Function in Cystic Fibrosis Patients: Evaluation and Comparison Between Two Decades in a Retrospective Monocentric Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01651455

Acronym

MAESTRALE

Enrollment

Registered

2012-07-27

Start date

2012-09-30

Completion date

2013-06-30

Last updated

2013-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis, Pseudomonas Aeruginosa

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 15 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results