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Nasal Nitric Oxide Test for Primary Ciliary Dyskinesia

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Creation of Nasal NO REDCap registry

Evaluation of utility of PCD diagnostic testing

Secondary outcome measures

Refinement and Improvement of PCD Diagnostic Testing

Side effects data

From 2021 Phase 4 trial • 519 Patients • NCT03081052

28%

Venous Thromboemolic DVT

13%

Venous Thromboembolic Other

11%

New Onset Atrial Fibrillation

All Cause Mortality

Arterial Thromboembolic CVA/Stroke

Venous Thromboembolic PE

Arterial Thromboembolic Mesenteric Ischemia

Arterial Thromboembolic Myocardial Infarction

Upper GI Bleed

Lower GI Bleed

100%

80%

60%

40%

20%

Study treatment Arm

Lung Transplant With iNO

Lung Transplant With iEPO

Heart Transplant & LVAD Implantation With iNO

Heart Transplant & LVAD Implantation With iEPO

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

UConn HealthOTHER

211 Previous Clinical Trials

60,571 Total Patients Enrolled

Connecticut Children's Medical CenterLead Sponsor

71 Previous Clinical Trials

31,464 Total Patients Enrolled

Melanie S Collins, MDPrincipal InvestigatorConnecticut Children's Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being recruited for this trial?

"Per the information hosted on clinicaltrials.gov, this experiment is actively recruiting participants. The original posting was made on September 27th 2023 and there have been subsequent revisions as recently as one day ago."

Answered by AI

Approximately how much time is required to complete this medical experiment?

"This clinical research is expected to span a duration of 3 Years, with its three principal stages taking ~3 weeks for screening, 3 Years for treatment and an additional 3 Years dedicated to data collection."

Answered by AI

What is the current scale of participants involved in this experiment?

"Affirmative, the information on clinicaltrials.gov indicates that this experiment is presently recruiting test subjects. It was initially advertised on September 27th 2023 and was updated just a day later. This trail requires 50 volunteers to be recruited from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Utility of PCD Diagnostics to Improve Clinical Care

2023. "Utility of PCD Diagnostics to Improve Clinical Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05889013.