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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05474430
Other study ID # 202102125
Secondary ID R01AI143671
Status Recruiting
Phase
First received
Last updated
Start date December 20, 2021
Est. completion date July 2024

Study information

Verified date November 2023
Source University of Iowa
Contact Philip M Polgreen, MD
Phone (319) 384-6194
Email philip-polgreen@uiowa.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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


Locations

Country Name City State
United States University of Iowa Hospitals and Clinics Iowa City Iowa

Sponsors (3)

Lead Sponsor Collaborator
Philip Polgreen National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of Chloride Transport Values Comparison of chloride transport values in cystic fibrosis carrier group vs control group via t-test. At baseline
Primary Comparison of Bicarbonate Transport Values Comparison of bicarbonate transport values in cystic fibrosis carrier group vs control group via t-test. At baseline
Primary 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. At baseline
Primary Comparison of Mucous Viscosity Values Comparison of mucous viscosity values in cystic fibrosis carrier group vs control group via t-test. At baseline
Primary Comparison of Bacterial Killing Values Comparison of bacterial killing values in cystic fibrosis carrier group vs control group via t-test. At baseline
Secondary 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. At baseline
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