Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity

NCT ID: NCT05474430

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-20

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carrier State Respiratory Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cystic Fibrosis Carrier Group

Participants have been identified as Cystic Fibrosis Carriers via previous genetic testing.

No interventions assigned to this group

Control Group

Participants have been identified as not being Cystic Fibrosis Carriers via previous genetic testing.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Currently sick with a respiratory infection
* Prisoner Status
* Unable to provide own written, informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Philip Polgreen

OTHER

Sponsor Role lead

Responsible Party

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Philip Polgreen

Professor, Internal Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Philip M Polgreen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Philip M Polgreen, MD

Role: CONTACT

(319) 384-6194

Shelby L Francis, PhD

Role: CONTACT

319-678-8037

Facility Contacts

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Shelby L Francis, PhD

Role: primary

319-678-8037

Other Identifiers

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R01AI143671

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202102125

Identifier Type: -

Identifier Source: org_study_id

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