Health TrialsbyHealthPanel

Utility of PCD Diagnostics to Improve Clinical Care

ConditionPrimary Ciliary Dyskinesia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorConnecticut Children's Medical Center

About this trial

This cross-sectional and longitudinal observational study is to gather data on the utility of tests that are used to make a diagnosis of primary ciliary dyskinesia (PCD). There is new testing available, called nasal nitric oxide testing, that non-invasively measures nitric oxide levels in the sinus cavity. Individuals with PCD characteristically have low levels, but this testing does not have extensive data from everyday clinical practice. The objective of this proposal is to improve the diagnostic approach to children and adults with clinical concerns for primary ciliary dyskinesia (PCD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 2 years of age

Neonatal respiratory distress

Chronic nasal congestion/runny nose

Chronic cough

Disqualifiers

Recent history of sinus surgery or bloody nose in the past week

Age < 2 years of age

Inability to tolerate probe in nose

Sinusitis or other respiratory exacerbation currently being treated with antibiotics

Trial population

The target population are ages 2 and up. Participant selection will be on a referral basis for the consideration of a clinical suspicion for PCD. Participants will be identified by pulmonary providers that consider testing for PCD based on the clinical symptoms of the participant. These providers will thenrefer for enrollment in the study based on the clinical considerations for a diagnosis of PCD.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Nasal Nitric Oxide testing

    Device

    Collection of already performed clinical data and nNO testing

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Nasal Nitric Oxide1 intervention

Trial outcomes

Primary outcomes

1

Creation of Nasal NO REDCap registry

To establish a research registry to characterize the features of individuals that undergo PCD diagnostic testing at Connecticut Children's Medical Center and UCONN.

Time frame
2-3 years
2

Evaluation of utility of PCD diagnostic testing

To evaluate the utility of PCD diagnostic testing, including potential use of nasal nitric oxide in comparison to genetic testing and ciliary biopsy, in pulmonary practice at Connecticut Children's Medical Center and UCONN.

Time frame
2-3 years

Secondary outcomes

1

Refinement and Improvement of PCD Diagnostic Testing

To refine and improve current diagnostic processes for PCD diagnosis at CCMC using information gathered from the research registry established through Primary aims 1 and 2.

Time frame
1-2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Connecticut Children's Medical Center

Lead sponsor

UConn Health

Collaborator

Source ClinicalTrials.gov
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