Using nasal nitric oxide testing to improve diagnosis of primary ciliary dyskinesia
A Clinical Study to Gather Data on the Utility of Tests That Are Used to Make a Diagnosis of Primary Ciliary Dyskinesia (PCD)
This study is testing if a simple nasal test can help doctors diagnose primary ciliary dyskinesia in people aged 2 and older who show symptoms of the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Connecticut Children's Medical Center Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Trial ID | NCT05889013 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on the effectiveness of nasal nitric oxide testing as a diagnostic tool for primary ciliary dyskinesia (PCD). Participants will be referred by pulmonary providers based on clinical symptoms suggestive of PCD. The study will enroll individuals aged 2 years and older who meet specific clinical criteria and provide informed consent. The goal is to enhance the diagnostic approach for PCD by gathering real-world data on this non-invasive testing method.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 2 years and older with clinical symptoms suggestive of primary ciliary dyskinesia.
Not a fit: Patients with recent sinus surgery, current respiratory exacerbations, or those unable to tolerate the testing 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 the use of nasal nitric oxide testing is gaining traction, extensive data from everyday clinical practice is still limited, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 2 years of age * Must have two of the following clinical history points: * Neonatal respiratory distress * Chronic nasal congestion/runny nose * Chronic cough * Situs/laterality defects * Bronchiectasis * Ability to provide informed consent or consent of parent/guardian and ass Exclusion Criteria: * Recent history of sinus surgery or bloody nose in the past week * Age \< 2 years of age * Inability to tolerate probe in nose * Sinusitis or other respiratory exacerbation currently being treated with antibiotics * Admitted to hospital for respiratory exacerbation (inpatient status) * Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by the IRB) * Any other reason for which the study investigators feel the patient is not a good candidate to complete the testing
Where this trial is running
Hartford, Connecticut
- Pulmonary Division — Hartford, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Melanie S Collins, MD — Connecticut Children's Medical Center
- Study coordinator: Melanie S Collins, MD
- Email: mcollin@connecticutchildrens.org
- Phone: 860-545-9440
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.