Clinical trial Recruiting at 1 site Observational Ages 6 and up

Improving lung function in children with cystic fibrosis

Official title: Serum Human Epididymis Protein 4 and Pulmonary Function Before and After Structural Quality Improvement Protocol Among Cystic Fibrosis Patients

Run by Ain Shams University · NCT06915961 · Data updated 2026-11-12

This study is testing a new plan to help improve lung function in children with cystic fibrosis by seeing if personalized treatment can increase their breathing ability over a year.

Quick facts

Study typeObservational
Ages6 Years and up
SexAll
Enrollment35 (estimated)
SponsorAin Shams University
Academic / other
Locations1 site (Cairo, Abbasia)
StatusRecruiting
StartedOctober 7, 2024
Main results expectedOctober 7, 2025
Study endsDecember 12, 2025
Registry record updatedApril 8, 2025
Trial IDNCT06915961 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are pediatric patients aged 6 to 18 years diagnosed with cystic fibrosis and exhibiting impaired pulmonary function.

Probably not a fit

Patients who are unable to perform spirometry will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to implement a quality improvement plan to achieve a 5% increase in the Forced Expiratory Volume in 1st second (FEV1) in pediatric patients with cystic fibrosis over a 12-month period. The study will involve 35 children aged 6 to 18 years who have impaired pulmonary function. Participants will be monitored at a specialized clinic where a multidisciplinary team will develop and adjust individualized treatment plans based on standardized care algorithms. Serum levels of human epididymis protein 4 (HE4) will also be measured before and after the intervention to assess its impact on pulmonary function.

Why it matters

Potential benefit: If successful, this approach could lead to improved lung function and overall health in children with cystic fibrosis.

How similar studies have gone: While similar quality improvement initiatives have shown promise in enhancing care for cystic fibrosis, this specific approach is novel in its implementation.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Ain Shams university
    Cairo, Abbasia, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.