Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorPhilip Polgreen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Currently sick with a respiratory infection
Prisoner Status
Unable to provide own written, informed consent
Trial population
CF Carriers and Controls who are not CF carriers.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
160 Participants
are grouped into 2 trial groupsGroup A: Cystic Fibrosis Carrier Group
Group B: Control Group
Trial outcomes
Primary outcomes
1
Comparison of Chloride Transport Values
Comparison of chloride transport values in cystic fibrosis carrier group vs control group via t-test.
Time frame
At baseline2
Comparison of Bicarbonate Transport Values
Comparison of bicarbonate transport values in cystic fibrosis carrier group vs control group via t-test.
Time frame
At baseline3
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.
Time frame
At baseline4
Comparison of Mucous Viscosity Values
Comparison of mucous viscosity values in cystic fibrosis carrier group vs control group via t-test.
Time frame
At baselineSecondary 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.
Time frame
At baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Philip Polgreen
Lead sponsor
University of Iowa
Sponsor institution
National Institutes of Health (NIH)
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov