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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cystic Fibrosis Pseudomonas Aeruginosa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort first decade

Patients born between 01/01/1979 and 12/31/1984

No interventions assigned to this group

Cohort second decade

Patients born between 01/01/1991 and 12/31/1996

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Baroukh Maurice Assael, Professor

Role: PRINCIPAL_INVESTIGATOR

U.O. Fibrosi Cistica Azienda Ospedaliera Verona

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

U.O. Azienda Ospedaliera

Verona, Veneto, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MAESTRALE

Identifier Type: -

Identifier Source: org_study_id