Utility of PCD Diagnostics to Improve Clinical Care

Vanderbilt University Medical Center

Status: Enrolling

Conditions: Primary Ciliary Dyskinesia

Treatments: Other: nNO testing

Study type: Interventional

Funder types: Other

Identifiers

NCT03704207

IRB #160951

Details and patient eligibility

About

This is a study evaluating the utility of current Primary Ciliary Dyskinesia (PCD) diagnostic tests, including nasal nitric oxide testing.

Full description

This study is a prospective data collection of individuals referred to the investigators clinical center for considerations of PCD. Participants sign informed consent to have clinical information entered into a secure electronic database. As part of this study, participants may have nasal nitric oxide (nNO) testing performed. nNO testing is a research procedure, but it is a test with growing utility for making a diagnosis of PCD when performed in the right clinical setting.

Enrollment: 200 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Referred to center for PCD diagnosis considerations
• Ability to perform study procedures
• Age greater than 2 years of age

Exclusion criteria

• Age less than 2 years of age Inability to perform informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Nasal Nitric Oxide testing and collection of clinical data

Other group

Description:

Participants will have nNO testing is indicated. All participants in this study have some basic clinical data collected at time of enrollment. Participants with a confirmed diagnosis of PCD or in those participants with a working diagnosis of PCD in which ongoing nNO testing is performed have prospective data collection. Some participants have a confirmed diagnosis of PCD by genetics or ciliary biopsy at time of study entry and thus do not need nNO testing, but are followed prospectively with collection of basic clinical data

Treatment:

Other: nNO testing