Epididymis Protein 4 and Pulmonary Function With Quality Improvement Protocol Among Cystic Fibrosis Patients

Launched by AIN SHAMS UNIVERSITY · Apr 4, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating ways to improve lung function in children and adolescents with cystic fibrosis (CF), a genetic condition that affects the lungs and can lead to breathing difficulties. The goal is to help these patients increase a specific measure of lung function called Forced Expiratory Volume in 1 second (FEV1) by at least 5% over the course of a year. The study will also look at levels of a protein called human epididymis protein 4 (HE4) in the blood before and after the patients' lung function has improved.

To participate in this trial, individuals must be at least 6 years old and have a confirmed diagnosis of cystic fibrosis, which usually involves a positive sweat test or specific genetic mutations. They should also have a lung function measurement (FEV1) that is 80% or less of what is expected for their age. Participants can expect to undergo regular assessments to monitor their lung function and HE4 levels throughout the study. This research aims to enhance the quality of care for cystic fibrosis patients and could lead to better treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Pediatric CF patients diagnosed based on the Consensus Guidelines from the Cystic Fibrosis Foundation, with a positive sweat chloride test (≥60 milliequivalent/L) and/or the presence of two CF disease-causing gene mutations.
• • Age ≥6 years.
• • Forced expiratory volume in 1 second (FEV₁) ≤80%.
• Exclusion Criteria:
• • ●Patients are unable to perform spirometry.