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Observational Study on Nasal Nitric Oxide Testing for Primary Ciliary Dyskinesia

This study is looking into how a nasal nitric oxide test can help diagnose Primary Ciliary Dyskinesia (PCD), a condition that affects tiny hair-like structures in your airways. Researchers want to see how well the results of this nasal test compare to other common diagnostic tests for PCD, like ciliary biopsy and genetic testing. You can join if you are between 2 and 99 years old and have a PCD diagnosis, abnormal PCD test results, unexplained bronchiectasis (a lung condition), or are undergoing PCD diagnostic testing due to symptoms. The goal is to see if nasal nitric oxide testing can become an approved way to diagnose PCD in the future. This study is currently unclear on its recruitment status and plans to enroll 150 participants.

Study design
This is an observational study, meaning researchers will collect information without giving any specific treatments. It aims to enroll 150 participants.
What's involved
You would undergo nasal nitric oxide testing. Researchers will also collect data from your electronic medical records.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, comparing nasal nitric oxide to other diagnostic tests, will be measured throughout the study, for an average of 3 years.

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NCT05287022

Use of Nasal Nitric Oxide Testing in Improving Primary Ciliary Dyskinesia Clinical Care

Recruiting
Not specifiedAges 2–99Observational
Arkansas Children's Hospital Research Institute
~150 participants
Updated 2025-01-30 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measuring nasal nitric oxide in comparison to ciliary biopsy and genetic testing for the diagnosis of PCD
Measured over throughout the study, an average of 3 years

Conditions

Primary Ciliary Dyskinesia

Explore related trials

BronchiectasisImmotile cilia syndrome

Where it's being run

1 sites across 1 states
Arkansas1

Who to contact

Zena Ghazala, MD
[email protected]
5013641006
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Individuals who are diagnosed with Primary Ciliary Dyskinesia OR
Individuals with abnormal PCD diagnostics (abnormal ciliary biopsy or PCD genetics) OR
Individuals with unexplained bronchiectasis OR
Individuals undergoing PCD diagnostic testing (ciliary biopsy, PCD genetic testing) or concern based on clinical symptoms (at least two of the following):
Neonatal respiratory distress
Organ laterality defects
Year-round cough starting in first year of life or bronchiectasis on chest CT
Year-round nasal congestion starting in first year of life or pansinusitis
Multiple ear infections in the first two years of life with sequelae (e.g. ear tubes, chronic effusion, abnormal audiological exam)
History of recurrent pneumonias (at least 2 in one year or more than 3 at any time)
Ability to provide consent for participation in study by the participants or guardian
Ability to perform the test
Age \>= 2 years of age

Exclusion

Individuals who are unable to understand the requirements of the study.
Individuals (or guardians) who are unwilling to provide consent.
Individuals who are unable to complete the testing
Recent history of sinus surgery (within four weeks) or bloody nose (within one week) of testing (they can be included at a later date)
Patients who are currently being treated (within one week) with antibiotics for sinusitis or respiratory symptoms (they can be included at a later date)
Age \<2 years of age

What this trial measures

  • Measuring nasal nitric oxide in comparison to ciliary biopsy and genetic testing for the diagnosis of PCDthroughout the study, an average of 3 years

    Individuals with PCD have characteristically low values of nNO; values below an established cut-off of 77nL/min are strongly associated with PCD in compatible clinical settings. These values are not well established for individuals who are in 2-5 years of age. nNO measurements (in nL/min) in 2-5 years of age will be compared to the diagnosis of PCD and assessed to establish diagnostic cut-offs.