NCT05889013 Utility of PCD Diagnostics to Improve Clinical Care
| NCT ID | NCT05889013 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Connecticut Children's Medical Center |
| Condition | Primary Ciliary Dyskinesia |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-10-17 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-10-17 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This cross-sectional and longitudinal observational study is to gather data on the utility of tests that are used to make a diagnosis of primary ciliary dyskinesia (PCD). There is new testing available, called nasal nitric oxide testing, that non-invasively measures nitric oxide levels in the sinus cavity. Individuals with PCD characteristically have low levels, but this testing does not have extensive data from everyday clinical practice. The objective of this proposal is to improve the diagnostic approach to children and adults with clinical concerns for primary ciliary dyskinesia (PCD).
Eligibility 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
Contact & Investigator
Melanie S Collins, MD
PRINCIPAL INVESTIGATOR
Connecticut Children's Medical Center
Frequently Asked Questions
Who can join the NCT05889013 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Primary Ciliary Dyskinesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05889013 currently recruiting?
Yes, NCT05889013 is actively recruiting participants. Contact the research team at mcollin@connecticutchildrens.org for enrollment information.
Where is the NCT05889013 trial being conducted?
This trial is being conducted at Hartford, United States.
Who is sponsoring the NCT05889013 clinical trial?
NCT05889013 is sponsored by Connecticut Children's Medical Center. The principal investigator is Melanie S Collins, MD at Connecticut Children's Medical Center. The trial plans to enroll 50 participants.