Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity

Estimating the Risk for and Severity of Respiratory Infections Attributable to CFTR Heterozygosity

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05474430

Enrollment

160

Registered

2022-07-26

Start date

2021-12-20

Completion date

2026-12-01

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carrier State, Respiratory Infections

Brief summary

A research team member will brush the inferior surface of the subjects' middle turbinate (nasal cavity) using a cytology brush to obtain the cells needed to perform our functional respiratory assays. An individual trained in phlebotomy will draw one 3 ml lavender top tube of blood to test c-reactive protein, calprotectin, and lactoferrin. They will also draw a 5 ml gold top serum separator tube of blood to test fibroblast growth factor-19. The participant will answer questions from the baseline survey and report their current medications interview-style with the research team member.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Comparison of Chloride Transport Values	At baseline	Comparison of chloride transport values in cystic fibrosis carrier group vs control group via t-test.
Comparison of Bicarbonate Transport Values	At baseline	Comparison of bicarbonate transport values in cystic fibrosis carrier group vs control group via t-test.
Comparison of Airway Surface Liquid pH Values	At baseline	Comparison of airway surface liquid pH values in cystic fibrosis carrier group vs control group via t-test.
Comparison of Mucous Viscosity Values	At baseline	Comparison of mucous viscosity values in cystic fibrosis carrier group vs control group via t-test.
Comparison of Bacterial Killing Values	At baseline	Comparison of bacterial killing values in cystic fibrosis carrier group vs control group via t-test.

Secondary

Measure	Time frame	Description
Comparison of Fibroblast Growth Factor-19 Values	At baseline	Comparison of fibroblast growth factor-19 values in cystic fibrosis carrier group vs control group via t-test.

Countries

United States

Contacts

CONTACTPhilip M Polgreen, MD

philip-polgreen@uiowa.edu(319) 384-6194

CONTACTShelby L Francis, PhD

shelby-francis@uiowa.edu319-678-8037

PRINCIPAL_INVESTIGATORPhilip M Polgreen, MD

University of Iowa

Outcome results