Recruiting

PCD Diagnostic Tests

Sponsor:

Vanderbilt University Medical Center

Code:

NCT03704207

Conditions

Primary Ciliary Dyskinesia

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

Interventions

nNO testing

Study Details

Brief summary:

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

Conditions

Primary Ciliary Dyskinesia

Study ID

NCT03704207

Start date

Jun 1, 2017

Status verified date

Jun, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Nasal Nitric Oxide testing and collection of clinical data

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

Interventions

nNO testing

Collection of already performed clinical data and nNO testing

Primary outcome measure

  • frequency of nNO tests performed [ Time Frame: 3 years ]
  • Frequency of genetic tests performed [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Michael O'Connor, MD

615.343.7617michael.g.oconnor@vumc.org

Locations

Vanderbilt Children's hospital

Recruiting

Nashville, Tennessee, United States, 37232

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jul 6, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-07-06.