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Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity

Sponsor
Philip Polgreen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05474430
Collaborator
National Institutes of Health (NIH) (NIH), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
160
Enrollment
16
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    160 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Estimating the Risk for and Severity of Respiratory Infections Attributable to CFTR Heterozygosity
    Anticipated Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of Chloride Transport Values [At baseline]

      Comparison of chloride transport values in cystic fibrosis carrier group vs control group via t-test.

    2. Comparison of Bicarbonate Transport Values [At baseline]

      Comparison of bicarbonate transport values in cystic fibrosis carrier group vs control group via t-test.

    3. Comparison of Airway Surface Liquid pH Values [At baseline]

      Comparison of airway surface liquid pH values in cystic fibrosis carrier group vs control group via t-test.

    4. Comparison of Mucous Viscosity Values [At baseline]

      Comparison of mucous viscosity values in cystic fibrosis carrier group vs control group via t-test.

    5. Comparison of Bacterial Killing Values [At baseline]

      Comparison of bacterial killing values in cystic fibrosis carrier group vs control group via t-test.

    Secondary Outcome Measures

    1. Comparison of Fibroblast Growth Factor-19 Values [At baseline]

      Comparison of fibroblast growth factor-19 values in cystic fibrosis carrier group vs control group via t-test.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Philip Polgreen
    • National Institutes of Health (NIH)
    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    • Principal Investigator: Philip M Polgreen, MD, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Philip Polgreen, Professor, Internal Medicine, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT05474430
    Other Study ID Numbers:
    • 202102125
    • R01AI143671
    First Posted:
    Jul 26, 2022
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Respiratory Tract Infections

    Study Results

    No Results Posted as of Aug 3, 2022