Diagnosis of Primary Ciliary Dyskinesia. An Official American Thoracic Society Clinical Practice Guideline.
Adam J Shapiro, Stephanie D Davis, Deepika Polineni...
https://pubmed.ncbi.nlm.nih.gov/29905515Actively Recruiting
Age: 2Years - 99Years
All Genders
ID05287022
Use of Nasal Nitric Oxide Testing in Improving Primary Ciliary Dyskinesia Clinical Care
Led by Arkansas Children's Hospital Research Institute · Updated on 2025-01-30
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying primary ciliary dyskinesia (PCD), a condition affecting nasal passages, to better understand and improve how it is diagnosed. The study focuses on measuring nitric oxide levels in the nose and comparing these results with other tests like ciliary biopsy and genetic testing to see how often they agree. This observational study aims to refine diagnostic methods and may help develop a new screening test for PCD in the future. Participants are referred by their doctors for nasal nitric oxide testing, which is done using special equipment in a hospital pulmonary function lab. The test is non-invasive and measures nitric oxide during normal breathing without sedation. Although this test is not yet officially approved for diagnosing PCD, its results will be shared with clinicians alongside standard diagnostic tests. Data collected from participants will be securely stored and used to improve PCD diagnosis methods. During the study, participants or their guardians will give consent before testing. Information from medical records will also be collected to support research. The study will monitor nasal nitric oxide levels over about three years, comparing different breathing methods during testing. Participants can expect non-invasive tests with little risk, and the research team will analyze how nitric oxide testing relates to existing PCD diagnostic tools to help improve clinical care.
CONDITIONS
Brief Title
Use of Nasal Nitric Oxide Testing in Improving Primary Ciliary Dyskinesia Clinical Care
Who Can Participate
Age: 2Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Individuals diagnosed with Primary Ciliary Dyskinesia or with abnormal PCD diagnostics (ciliary biopsy or genetic tests)
- Individuals with unexplained bronchiectasis
- Individuals undergoing PCD diagnostic testing or with at least two clinical symptoms such as neonatal respiratory distress, organ laterality defects, chronic cough or nasal congestion starting in the first year of life, multiple ear infections in early childhood, or recurrent pneumonias
- Ability to provide consent by participant or guardian
- Ability to perform the nasal nitric oxide test
- Age 2 years or older
You will not qualify if you...
- Individuals unable to understand study requirements
- Individuals or guardians unwilling to provide consent
- Individuals unable to complete the nasal nitric oxide testing
- Recent sinus surgery within four weeks or bloody nose within one week before testing
- Current treatment with antibiotics for sinusitis or respiratory symptoms within one week
- Age under 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Single assessment
Participants undergo nasal nitric oxide testing to help correlate with other diagnostic tests for Primary Ciliary Dyskinesia. This test is non-invasive and involves measuring nitric oxide levels during regular breathing.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 3 years
Data from participants' medical records will be collected and analyzed over time to improve diagnostic testing for Primary Ciliary Dyskinesia.
Data collected from medical records without additional visits
Trial Site Locations
Total: 1 location
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
Loading map...
Research Team
Z
Zena Ghazala, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Diagnosis, monitoring, and treatment of primary ciliary dyskinesia: PCD foundation consensus recommendations based on state of the art review.
Adam J Shapiro, Maimoona A Zariwala, Thomas Ferkol...
https://pubmed.ncbi.nlm.nih.gov/26418604Nasal Nitric Oxide Measurement in Primary Ciliary Dyskinesia. A Technical Paper on Standardized Testing Protocols.
Adam J Shapiro, Sharon D Dell, Benjamin Gaston...
https://pubmed.ncbi.nlm.nih.gov/31770003The dangers of widespread nitric oxide screening for primary ciliary dyskinesia.
Samuel A Collins, Laura Behan, Amanda Harris...
https://pubmed.ncbi.nlm.nih.gov/26896442