Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity

Recruiting

• Conditions: Carrier State; Respiratory Infections

• Registration Number: NCT05474430
• Lead Sponsor: Philip Polgreen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-20
• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-22
• Study First Posted: 2022-07-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Mucous Viscosity Values	At baseline	Comparison of mucous viscosity values in cystic fibrosis carrier group vs control group via t-test.
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 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 Bacterial Killing Values	At baseline	Comparison of bacterial killing values in cystic fibrosis carrier group vs control group via t-test.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States