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

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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis

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 Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• Italy
  • Veneto
    • Verona, Veneto, Italy, 37126
      • U.O. Azienda Ospedaliera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients affected with Pseudomonas A. living in the N-E area of Italy.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort first decade; Patients born between 01/01/1979 and 12/31/1984
Cohort second decade; Patients born between 01/01/1991 and 12/31/1996

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Collaborators: Medidata Solutions
• Investigators: Principal Investigator: Baroukh Maurice Assael, Professor, U.O. Fibrosi Cistica Azienda Ospedaliera Verona

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 25, 2012
• First Submitted That Met QC Criteria: July 26, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Estimate): July 31, 2013
• Last Update Submitted That Met QC Criteria: July 30, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Cystic Fibrosis; Pseudomonas Aeruginosa
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: MAESTRALE