Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity

Respiratory Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05474430
• Other study ID #: 202102125
• Secondary ID: R01AI143671
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Carrier State
• Communicable Diseases
• Infections
• Respiratory Infections
• Respiratory Tract Infections

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