Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Carrier State, Respiratory Infections. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Estimating the Risk for and Severity of Respiratory Infections Attributable to CFTR Heterozygosity
Overview
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.
Primary outcome measures
- Comparison of Chloride Transport Values [Time frame: At baseline]
- Comparison of Bicarbonate Transport Values [Time frame: At baseline]
- Comparison of Airway Surface Liquid pH Values [Time frame: At baseline]
- Comparison of Mucous Viscosity Values [Time frame: At baseline]
- Comparison of Bacterial Killing Values [Time frame: At baseline]
Secondary outcome measures (1)
- Comparison of Fibroblast Growth Factor-19 Values [Time frame: At baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Iowa Hospitals and Clinics — Iowa City
Identifiers
NCT: NCT05474430 · 202102125 · R01AI143671