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Estimating Risk of Respiratory Infections Attributable to CFTR Heterozygosity

P

Philip Polgreen

Status

Enrolling

Conditions

Carrier State
Respiratory Infections

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT05474430
R01AI143671 (U.S. NIH Grant/Contract)
202102125

Details and patient eligibility

About

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.

Enrollment

160 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

160 participants in 2 patient groups

Cystic Fibrosis Carrier Group
Description:
Participants have been identified as Cystic Fibrosis Carriers via previous genetic testing.
Control Group
Description:
Participants have been identified as not being Cystic Fibrosis Carriers via previous genetic testing.

Trial contacts and locations

1

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Central trial contact

Philip M Polgreen, MD; Shelby L Francis, PhD

Data sourced from clinicaltrials.gov

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