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nNO Testing for Primary Ciliary Dyskinesia

N/A

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than 2 years of age

Must not have

Age less than 2 years of age

Inability to perform informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether the current tests for Primary Ciliary Dyskinesia are effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves diagnostic testing rather than medication or invasive treatments, significant side effects are not expected. However, discomfort during nNO testing may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 2 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 2 years old.

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of genetic tests performed

frequency of nNO tests performed

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 3Eligibility criteria met