Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity

NCT05474430 | Recruiting

• 2 other identifiers: 202102125R01AI143671
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Carrier State; Respiratory Infections

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Comparison of Fibroblast Growth Factor-19 Values

  At baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CF Carriers and Controls who are not CF carriers.

You may qualify if:

• Previously tested and shown to be a CF carrier
• English-speaking
• Previously tested and shown to not be a CF carrier or CF patient
• English-speaking

You may not qualify if:

• Currently sick with a respiratory infection
• Prisoner Status
• Unable to provide own written, informed consent

Sponsors & Collaborators

• Philip Polgreen: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal cells and blood will be collected.

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Philip M Polgreen, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip M Polgreen, MD

CONTACT

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

Shelby L Francis, PhD

CONTACT

319-678-8037; shelby-francis@uiowa.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Internal Medicine

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 26, 2022
• Study Start: December 20, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)