Detecting hidden small airway issues in cystic fibrosis patients
The Measurement and Analysis of Maximal Expiratory Flow Volume Loops at Low Lung Volumes in Children With Cystic Fibrosis and Normal Routine Lung Function.
This study is trying to find hidden breathing problems in children and adults with cystic fibrosis who seem healthy on standard lung tests by looking at their lung scans and airflow patterns.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 5 Years to 40 Years |
| Sex | All |
| Sponsor | Gelb, Arthur F., M.D. Indiv |
| Locations | 2 sites (Lakewood, California and 1 other locations) |
| Trial ID | NCT03839992 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify unsuspected small airways obstruction in children and adults with cystic fibrosis who have normal routine spirometry results. It utilizes retrospective analysis based on previous research that demonstrated the ability to detect airflow limitations at low lung volumes, despite normal FEV1 and FVC values. The study focuses on the correlation between abnormal expiratory airflow and the presence of bronchiectasis as shown in lung CT scans. By analyzing these factors, the researchers hope to improve the understanding of lung function in cystic fibrosis patients.
Who should consider this trial
Good fit: Ideal candidates are heterozygous or homozygous cystic fibrosis patients with normal pre bronchodilator spirometry results.
Not a fit: Patients with abnormal routine pre bronchodilator spirometry results will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of lung complications in cystic fibrosis patients.
How similar studies have performed: Previous studies have shown success in detecting small airway obstruction using similar methodologies, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Heterozygote or homozygote patients with cystic fibrosis with normal routine pre bronchodilator spirometry including normal FEV1(L), FVC(L) and FEV1/FVC%. Exclusion Criteria:Heterozygote or homozygote patients with cystic fibrosis with ABNORMAL routine pre bronchodilator spirometry \-
Where this trial is running
Lakewood, California and 1 other locations
- Arthur F Gelb MD — Lakewood, California, United States (Recruiting)
- Miller Children's Hospital and Long Beach Medical Center — Long Beach, California, United States (Recruiting)
Study contacts
- Principal investigator: Arthur Gelb, MD — University of California, Los Angeles
- Study coordinator: Arthur F Gelb, MD
- Email: afgelb@msn.com
- Phone: 562-565-5333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.