Assessing respiratory infection risks in CF carriers
Estimating the Risk for and Severity of Respiratory Infections Attributable to CFTR Heterozygosity
This study is testing if being a carrier of the CFTR gene mutation increases the risk of respiratory infections by comparing CF carriers with non-carriers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT05474430 on ClinicalTrials.gov |
What this trial studies
This observational study aims to estimate the risk of respiratory infections associated with being a carrier of the CFTR gene mutation. Participants will undergo a nasal cell collection and blood tests to measure specific biomarkers related to respiratory health. Additionally, they will complete a baseline survey and discuss their current medications with the research team. The study includes both CF carriers and a control group of non-carriers to compare outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals who have previously tested positive as CF carriers and English-speaking adults.
Not a fit: Patients currently suffering from a respiratory infection or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the respiratory health risks faced by CF carriers, potentially leading to better management strategies.
How similar studies have performed: While this approach is observational and may not have direct precedents, studies on CFTR mutations and respiratory health have shown varying degrees of success in understanding related risks.
Eligibility criteria
Show full inclusion / exclusion criteria
CF Carrier Inclusion Criteria: * Previously tested and shown to be a CF carrier * English-speaking Control Group Inclusion Criteria: * Previously tested and shown to not be a CF carrier or CF patient * English-speaking Exclusion Criteria: * Currently sick with a respiratory infection * Prisoner Status * Unable to provide own written, informed consent
Where this trial is running
Iowa City, Iowa
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Philip M Polgreen, MD — University of Iowa
- Study coordinator: Philip M Polgreen, MD
- Email: philip-polgreen@uiowa.edu
- Phone: (319) 384-6194
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.