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

NCT06915961 | Recruiting

• 1 other identifier: FMASU MD267/2024
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis (CF)

Keywords

Quality Improvement (QI)

Outcome Measures

Primary Outcomes (1)

• Quality Improvement Protocol for Achieving a 5% Increase in FEV₁% Predicted Value in CF Patients"

  Implementation of a quality improvement protocol to achieve a 5% increase in the FEV₁% predicted value in cystic fibrosis patients with impaired pulmonary function. Pulmonary function will be assessed using spirometry at baseline, six months, and 12 months.

  12 months

Secondary Outcomes (1)

• Serum HE4 Levels Before and After Pulmonary Function Improvement

  12 months

Study Arms (1)

Pediatric CF patients aged 6 years and above with an FEV₁% predicted below 80%.

Using quality improvement principles for patient care and reassessing after one year.

Eligibility Criteria

• Age: 6 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be conducted on 35 children diagnosed with cystic fibrosis, patients will be between the age of 6 years and 18 years old, and they will be selected during their follow-up visits to Pediatric Chest Clinic, Ain Shams University Hospital.

You may qualify if:

• 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%.

You may not qualify if:

• ●Patients are unable to perform spirometry.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, Abbasia, 00202, Egypt

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Eman Fawzy

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eman Fawzy, MD

CONTACT

Egypt: 201011778583; eman199358@gmail.com

Terez Boshra

CONTACT

+201224035744; Terezboshra@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: April 8, 2025
• Study Start: October 7, 2024
• Primary Completion: October 7, 2025
• Study Completion: December 12, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-02

Locations

EG (1)