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NCT Number: NCT05474430

Estimating Risk 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.

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Key information

Conditions

Carrier State Infections Respiratory Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Shelby L Francis, PhD

CONTACT

[email protected]

319-678-8037

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Comparison of Chloride Transport Values

    Time frame: At baseline

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

  2. Comparison of Bicarbonate Transport Values

    Time frame: At baseline

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

  3. Comparison of Airway Surface Liquid pH Values

    Time frame: At baseline

    Comparison of airway surface liquid pH values in cystic fibrosis carrier group vs control group via t-test.

  4. Comparison of Mucous Viscosity Values

    Time frame: At baseline

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

  5. Comparison of Bacterial Killing Values

    Time frame: At baseline

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

Secondary outcomes

  1. Comparison of Fibroblast Growth Factor-19 Values

    Time frame: At baseline

    Comparison of fibroblast growth factor-19 values in cystic fibrosis carrier group vs control group via t-test.

Study contacts

Contact information is provided by the study sponsor or research team.

Philip M Polgreen, MD

CONTACT

[email protected]

(319) 384-6194

Shelby L Francis, PhD

CONTACT

[email protected]

319-678-8037

Sponsors and collaborators

Lead sponsor

Philip Polgreen

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 26, 2022
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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