Utility of PCD Diagnostics to Improve Clinical Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-17

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of Nasal Nitric Oxide Testing in Improving Primary Ciliary Dyskinesia Clinical Care

NCT05287022

Primary Ciliary Dyskinesia

RECRUITING

Infant Nasal Nitric Oxide Levels in Congenital Heart Disease

NCT02551107

Congenital Heart Disease

TERMINATED NA

Early Detection and Characterization of Primary Ciliary Dyskinesia

NCT01070914

Primary Ciliary Dyskinesia

UNKNOWN

Nasal Nitric Oxide Across Mutations in Primary Ciliary Dyskinesia

NCT04949308

Ciliary Motility Disorders Primary Ciliary Dyskinesia

UNKNOWN

NPDT Evaluation in Children With CFTR and (PSC)

NCT00179439

Primary Sclerosing Cholangitis Inflammatory Bowel Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an observational study to gather data on the utility of tests that are used to make a diagnosis of primary ciliary dyskinesia (PCD). 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 then refer for enrollment in the study based on the clinical considerations for a diagnosis of PCD. Participants will be consented during the time of testing at the Pulmonary department. Any patient referred by a clinician for concerns for PCD, including those who have had PCD genetics sent, or a ciliary biopsy performed will be enrolled in the study. In addition, any participant who is referred for nasal nitric oxide testing and meets the inclusion and exclusion criteria for this testing, will also need to provide informed consent and be enrolled in the Nasal NO REDCap registry. This equipment is not currently FDA approved or CLIA certified for PCD diagnostic testing and therefore referring clinicians will be informed that the results of this test should not influence clinical decision making regarding the diagnosis of PCD. However, there is growing evidence that this testing has utility as a non-invasive screening tool for PCD and continued data from the general pediatric pulmonary population is needed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Ciliary Dyskinesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Nasal Nitric Oxide testing

Intervention Type DEVICE

Collection of already performed clinical data and nNO testing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nasal Nitric Oxide testing

Collection of already performed clinical data and nNO testing

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

nNO testing

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No