Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carrier State; Respiratory Infections

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Philip M Polgreen, MD; Phone Number: (319) 384-6194; Email: philip-polgreen@uiowa.edu
• Study Contact Backup: Name: Shelby L Francis, PhD; Phone Number: 319-678-8037; Email: shelby-francis@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Hospitals and Clinics
      • Contact: Shelby L Francis, PhD; Phone Number: 319-678-8037; Email: shelby-francis@uiowa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

CF Carriers and Controls who are not CF carriers.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cystic Fibrosis Carrier Group; Participants have been identified as Cystic Fibrosis Carriers via previous genetic testing.
Control Group; Participants have been identified as not being Cystic Fibrosis Carriers via previous genetic testing.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Philip Polgreen
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Philip M Polgreen, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 202102125; R01AI143671 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No