Nasal nitric oxide testing for better care in primary ciliary dyskinesia
Use of Nasal Nitric Oxide Testing in Improving Primary Ciliary Dyskinesia Clinical Care
This study is trying to see if measuring nitric oxide in the nose can help doctors diagnose primary ciliary dyskinesia more accurately for patients at Arkansas Children's Hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 2 Years to 99 Years |
| Sex | All |
| Sponsor | Arkansas Children's Hospital Research Institute Academic / other |
| Locations | 1 site (Little Rock, Arkansas) |
| Trial ID | NCT05287022 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the understanding of primary ciliary dyskinesia (PCD) by measuring nitric oxide levels in the nasal passages and correlating these results with existing diagnostic tests. Participants referred for nasal nitric oxide testing will undergo the procedure after providing informed consent. The study will collect data from electronic medical records to refine diagnostic testing for PCD at Arkansas Children's Hospital, involving collaboration with various medical specialties. The ultimate goal is to improve the accuracy of PCD diagnosis and potentially lead to the approval of nasal nitric oxide testing as a diagnostic tool.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with primary ciliary dyskinesia, those with abnormal diagnostic results, or individuals with unexplained bronchiectasis.
Not a fit: Patients who do not meet the inclusion criteria or have conditions unrelated to primary ciliary dyskinesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for patients with primary ciliary dyskinesia.
How similar studies have performed: While this approach is novel in the context of PCD, similar studies using nitric oxide testing in other respiratory conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Little Rock, Arkansas
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (Recruiting)
Study contacts
- Study coordinator: Zena Ghazala, MD
- Email: zbghazala@uams.edu
- Phone: 5013641006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.