Epididymis Protein 4 and Pulmonary Function With Quality Improvement Protocol Among Cystic
To implement a quality improvement plan aimed at achieving a 5% increase in the Forced expiratory volume in 1st second (FEV1) (% predicted value) in cystic fibrosis (CF) patients with impaired pulmonary function parameters over 12 months. Additionally, the plan aims to measure serum human epididymis protein 4 (HE4) lev
| Condition(s) | Cystic Fibrosis (CF) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | To implement a quality improvement plan aimed at achieving a 5% increase in the Forced expiratory volume in 1st second (FEV1) (% predicted value) in cystic fibrosis (CF) patients with impaired pulmonary function parameters over 12 months. Additionally, the plan aims to measure serum human epididymis protein 4 (HE4) levels in the studied subjects before and after pulmonary function improvement. |
| Who can participate | 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. |
| Ages | 6 Years |
| Sex | All |
| Lead sponsor | Ain Shams University |
| Locations | Cairo, Abbasia, Egypt |
| Start date | 2024-10-07 |
| NCT ID | NCT06915961 |
| Official listing | https://clinicaltrials.gov/study/NCT06915961 |