nNO Testing for Primary Ciliary Dyskinesia
MO
Overseen ByMichael O'Connor, MD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What is the purpose of this trial?
This is a study evaluating the utility of current Primary Ciliary Dyskinesia (PCD) diagnostic tests, including nasal nitric oxide testing.
Eligibility Criteria
This trial is for individuals suspected of having Primary Ciliary Dyskinesia (PCD) and are referred to a center for diagnosis. Participants must be able to perform the required study procedures and be older than 2 years. Those under 2 or unable to give informed consent cannot join.Inclusion Criteria
Referred to center for PCD diagnosis considerations
I can follow the study's required procedures.
I am older than 2 years.
Exclusion Criteria
I am under 2 years old.
I am unable to understand and give consent for treatment.
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Data Collection
Participants have clinical data collected and may undergo nasal nitric oxide (nNO) testing
3 years
Follow-up
Participants are monitored for safety and effectiveness after data collection
4 weeks
Treatment Details
Interventions
- PCD Diagnostic Tests
Trial Overview The study is evaluating the effectiveness of current diagnostic tests for PCD, focusing on nasal nitric oxide (nNO) testing, which measures the amount of nitric oxide in breath as an indicator of ciliary function.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Nasal Nitric Oxide testing and collection of clinical dataExperimental Treatment1 Intervention
Participants will have nNO testing is indicated. All participants in this study have some basic clinical data collected at time of enrollment. Participants with a confirmed diagnosis of PCD or in those participants with a working diagnosis of PCD in which ongoing nNO testing is performed have prospective data collection. Some participants have a confirmed diagnosis of PCD by genetics or ciliary biopsy at time of study entry and thus do not need nNO testing, but are followed prospectively with collection of basic clinical data
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Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Trials
922
Recruited
939,000+
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