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

Cystic Fibrosis Clinical Trial

— MAESTRALE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651455
• Other study ID #: MAESTRALE
• Status: Completed
• Phase: N/A
• First received: July 25, 2012
• Last updated: July 30, 2013
• Start date: September 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 15 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
Italy	U.O. Azienda Ospedaliera	Verona	Veneto

Sponsors (2)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.	Medidata Solutions

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients		5 years	No
Secondary	To identify clinical parameters or treatments correlated to FEV1 maintenance in two cohorts of cystic fibrosis patients		5 years	No
Secondary	To evaluate the number of patients with Pseudomonas Aeruginosa infection during observational period		5 years	No
Secondary	To describe length of time without Pseudomonas A. infection in non-colonized patients during observational period.		5 years	No