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Nasal Nitric Oxide Test for Primary Ciliary Dyskinesia (PCD Trial)

N/A

Recruiting

Led By Melanie S Collins, MD

Research Sponsored by Connecticut Children's Medical Center

Eligibility Criteria Checklist

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

Must have

Must have two of the following clinical history points: Neonatal respiratory distress, Chronic nasal congestion/runny nose, Chronic cough, Situs/laterality defects, Bronchiectasis

Age ≥ 2 years of age

Must not have

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)

Sinusitis or other respiratory exacerbation currently being treated with antibiotics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well a new test can help diagnose primary ciliary dyskinesia (PCD), a genetic condition causing difficulty breathing.

Who is the study for?

This trial is for individuals aged 2 years or older who may have primary ciliary dyskinesia (PCD). They should have symptoms like neonatal respiratory distress, chronic nasal issues, coughing, organ placement anomalies, or bronchiectasis. It's not for those currently hospitalized with respiratory issues, on antibiotics for sinusitis/respiratory problems, unable to tolerate a nasal probe, or unable to consent.

What is being tested?

The study is testing the effectiveness of nasal nitric oxide testing as a diagnostic tool for PCD. This non-invasive test measures nitric oxide in the sinuses; low levels are typical in PCD patients. The goal is to collect data from regular clinical use and improve diagnosis methods.

What are the potential side effects?

Since this trial involves non-invasive nasal nitric oxide testing rather than medication or invasive procedures, significant side effects are not expected. However, discomfort from the nasal probe might occur.

Eligibility Criteria

Inclusion Criteria

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

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I have at least two symptoms like chronic cough or nasal issues.

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I am at least 2 years old.

Exclusion Criteria

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

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I understand the study requirements and am willing to sign the consent form.

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I am currently taking antibiotics for sinusitis or another respiratory issue.

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I am currently hospitalized due to worsening breathing problems.

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I am under 2 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 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

Creation of Nasal NO REDCap registry

Evaluation of utility of PCD diagnostic testing

Secondary study objectives

Refinement and Improvement of PCD Diagnostic Testing

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 OxideExperimental Treatment1 Intervention

Participants who are referred by his/her clinician for nasal NO testing and meet the inclusion and exclusion criteria will undergo testing. Clinical information regarding prior diagnostic testing will be collected at time of enrollment. Participants that have a confirmed diagnosis of PCD by genetics or ciliary biopsy at time of study entry

0 / 6Eligibility criteria met