Utility of PCD Diagnostics to Improve Clinical Care

June 28, 2025 updated by: Michael O'Connor, Vanderbilt University Medical Center
This is a study evaluating the utility of current Primary Ciliary Dyskinesia (PCD) diagnostic tests, including nasal nitric oxide testing.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt Children's Hospital
        • Contact:
          • Michael O'Connor, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: nNO testing
Collection of already performed clinical data and nNO testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of nNO tests performed
Time Frame: 3 years
number of tests
3 years
Frequency of genetic tests performed
Time Frame: 3 years
number of tests
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

October 8, 2018

First Submitted That Met QC Criteria

October 11, 2018

First Posted (Actual)

October 12, 2018

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 28, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #160951

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Ciliary Dyskinesia

Clinical Trials on nNO testing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe