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RecruitingNCT05474430Updated Sep 4, 2026

Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity

An observational study in Carrier State and Respiratory Infections, sponsored by Philip Polgreen. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by Philip Polgreen · Observational

From the registry’s dates

  • Started Dec 2021; still recruiting 4 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
160
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Carrier State
  • Respiratory Infections
03

In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's planned enrollment of 160 is below the median of 300 across 295 observational studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Philip Polgreen is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

CF Carriers and Controls who are not CF carriers.

Eligibility 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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
160 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Comparison of Chloride Transport Values

    Comparison of chloride transport values in cystic fibrosis carrier group vs control group via t-test.

    Time frame: At baseline

  2. Comparison of Bicarbonate Transport Values

    Comparison of bicarbonate transport values in cystic fibrosis carrier group vs control group via t-test.

    Time frame: At baseline

  3. 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.

    Time frame: At baseline

  4. Comparison of Mucous Viscosity Values

    Comparison of mucous viscosity values in cystic fibrosis carrier group vs control group via t-test.

    Time frame: At baseline

  5. Comparison of Bacterial Killing Values

    Comparison of bacterial killing values in cystic fibrosis carrier group vs control group via t-test.

    Time frame: At baseline

Secondary outcomes

  1. 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.

    Time frame: At baseline

07

Study locations

1 of 1 sites recruiting
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05474430
Lead sponsor
Philip Polgreen
Collaborators
National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Philip Polgreen (Professor, Internal Medicine, University of Iowa) — Sponsor-investigator
First posted
Jul 26, 2022
Start date
Dec 20, 2021
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 4, 2026

Study contacts

Philip M Polgreen, MD
Contact
philip-polgreen@uiowa.edu
(319) 384-6194
Shelby L Francis, PhD
Contact
shelby-francis@uiowa.edu
319-678-8037
Philip M Polgreen, MD
principal investigator · University of Iowa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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