NCT03704207

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress81%
Jun 2017Jun 2028

Study Start

First participant enrolled

June 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

11 years

First QC Date

October 8, 2018

Last Update Submit

June 28, 2025

Conditions

Primary Ciliary Dyskinesia

Outcome Measures

Primary Outcomes (2)

  • frequency of nNO tests performed

    number of tests

    3 years

  • Frequency of genetic tests performed

    number of tests

    3 years

Study Arms (1)

Nasal Nitric Oxide testing and collection of clinical data

OTHER

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

Interventions

nNO testingOTHER

Collection of already performed clinical data and nNO testing

Nasal Nitric Oxide testing and collection of clinical data

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Children's hospital

Nashville, Tennessee, 37232, United States

RECRUITING

MeSH Terms

Conditions

Ciliary Motility Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesOtorhinolaryngologic DiseasesCiliopathiesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Central Study Contacts

Michael O'Connor, MD

CONTACT

615.343.7617michael.g.oconnor@vumc.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 12, 2018

Study Start

June 1, 2017

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

July 1, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)