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Utility of PCD Diagnostics to Improve Clinical Care
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).
Conditions:
🦠 Primary Ciliary Dyskinesia
🗓️ Study Start (Actual) 27 September 2023
🗓️ Primary Completion (Estimated) June 2024
✅ Study Completion (Estimated) June 2024
👥 Enrollment (Estimated) 50
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Hartford, Connecticut, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age ≥ 2 years of age
    • * Must have two of the following clinical history points:
    • * Neonatal respiratory distress
    • * Chronic nasal congestion/runny nose
    • * Chronic cough
    • * Situs/laterality defects
    • * Bronchiectasis
    • * Ability to provide informed consent or consent of parent/guardian and ass

    Exclusion Criteria:

    • * 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
    • * Admitted to hospital for respiratory exacerbation (inpatient status)
    • * 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)
    • * Any other reason for which the study investigators feel the patient is not a good candidate to complete the testing
Ages Eligible for Study: 2 Years to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 May 2023
  • First Submitted that Met QC Criteria 2 June 2023
  • First Posted 5 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 September 2023
  • Last Update Posted 2 October 2023
  • Last Verified August 2023
I'm interested ...!!