nNO Testing for Primary Ciliary Dyskinesia

Overseen By Michael O'Connor, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Age less than 2, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

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

Group I: Nasal Nitric Oxide testing and collection of clinical data Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+