Recruiting

Observational Study

Sponsor:

Philip Polgreen

Code:

NCT05474430

Conditions

Carrier State

Respiratory Infections

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05474430

Start date

Dec 20, 2021

Status verified date

Sep, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Comparison of Chloride Transport Values [ Time Frame: At baseline ]
  • Comparison of Bicarbonate Transport Values [ Time Frame: At baseline ]
  • Comparison of Airway Surface Liquid pH Values [ Time Frame: At baseline ]
  • Comparison of Mucous Viscosity Values [ Time Frame: At baseline ]
  • Comparison of Bacterial Killing Values [ Time Frame: At baseline ]

Central Contacts and Locations

Central contacts

Philip M Polgreen, MD

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

Shelby L Francis, PhD

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

Locations

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Shelby L Francis, PhD

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

More Information

Sponsor

Philip Polgreen

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Philip Polgreen on 2026-09-04.