Carrier StateNCT05474430
Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity
An observational study of Carrier State and Respiratory Infections, run by Philip Polgreen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Carrier State, Respiratory Infections
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2021to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: CF Carriers and Controls who are not CF carriers.
Who may be able to join
None listed.
Who cannot join
- Currently sick with a respiratory infection
- Prisoner Status
- Unable to provide own written, informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Shelby L Francis, PhD, 319-678-8037, shelby-francis@uiowa.edu
About this study
Official title: Estimating the Risk for and Severity 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.
- Conditions
- Carrier State, Respiratory Infections
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Chloride Transport Values
Comparison of chloride transport values in cystic fibrosis carrier group vs control group via t-test.
Measured: At baseline
Comparison of Bicarbonate Transport Values
Comparison of bicarbonate transport values in cystic fibrosis carrier group vs control group via t-test.
Measured: 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.
Measured: At baseline
Comparison of Mucous Viscosity Values
Comparison of mucous viscosity values in cystic fibrosis carrier group vs control group via t-test.
Measured: At baseline
Comparison of Bacterial Killing Values
Comparison of bacterial killing values in cystic fibrosis carrier group vs control group via t-test.
Measured: 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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start20 Dec 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carrier StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philip Polgreen
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor-investigator, Philip Polgreen, University of Iowa
- Investigators
- Philip M Polgreen, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474430
- Sponsor's protocol ID
- 202102125
- Other IDs
- R01AI143671
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2022
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating the Risk for and Severity of Respiratory Infections Attributable to CFTR Heterozygosity
- ClinicalTrials.gov ID
- NCT05474430
- Acronym / sponsor ID
- 202102125
- Conditions
- Carrier State, Respiratory Infections
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Philip PolgreenUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- CF Carriers and Controls who are not CF carriers.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Currently sick with a respiratory infection
- Prisoner Status
- Unable to provide own written, informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Comparison of Fibroblast Growth Factor-19 Values
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip M Polgreen, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carrier State and Respiratory Infections, run by Philip Polgreen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philip M Polgreen, MD ((319) 384-6194, philip-polgreen@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Chloride Transport Values (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.