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

This study has been completed.
Sponsor:
Collaborator:
Medidata Solutions
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01651455
First received: July 25, 2012
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Maintaining Lung Function in Cystic Fibrosis Patients: Evaluation and Comparison Between Two Decades in a Retrospective Monocentric Observational Study

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • To describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify clinical parameters or treatments correlated to FEV1 maintenance in two cohorts of cystic fibrosis patients [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To evaluate the number of patients with Pseudomonas Aeruginosa infection during observational period [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To describe length of time without Pseudomonas A. infection in non-colonized patients during observational period. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: September 2012
Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651455

Locations
Italy
U.O. Azienda Ospedaliera
Verona, Veneto, Italy, 37126
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Medidata Solutions
Investigators
Principal Investigator: Baroukh Maurice Assael, Professor U.O. Fibrosi Cistica Azienda Ospedaliera Verona
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01651455     History of Changes
Other Study ID Numbers: MAESTRALE
Study First Received: July 25, 2012
Last Updated: July 30, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Chiesi Farmaceutici S.p.A.:
Cystic Fibrosis
Pseudomonas Aeruginosa

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014