Recruiting

PCD Diagnostics

Sponsor:

Connecticut Children's Medical Center

Code:

NCT05889013

Conditions

Primary Ciliary Dyskinesia

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Interventions

Nasal Nitric Oxide testing

Study Details

Brief summary:

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 ID

NCT05889013

Start date

Oct 17, 2023

Status verified date

Sep, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Nasal Nitric Oxide

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

Interventions

Nasal Nitric Oxide testing

Collection of already performed clinical data and nNO testing

Primary outcome measure

  • Creation of Nasal NO REDCap registry [ Time Frame: 2-3 years ]
  • Evaluation of utility of PCD diagnostic testing [ Time Frame: 2-3 years ]

Central Contacts and Locations

Central contacts

Melanie S Collins, MD

860-545-9440mcollin@connecticutchildrens.org

Sigrid M Almeida, BS

8608375343salmeida@connecticutchildrens.org

Locations

Pulmonary Division

Recruiting

Hartford, Connecticut, United States, 06111

Contacts

Melanie S Collins, MD

8605459440mcollin@connecticutchildrens.org

Sigrid M Almeida, BS

8608375343salmeida@connecticutchildrens.org

More Information

Sponsor

Connecticut Children's Medical Center

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • PCD
  • nasal nitric oxide testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Connecticut Children's Medical Center on 2025-09-22.