Primary Ciliary DyskinesiaNCT03704207
Utility of PCD Diagnostics to Improve Clinical Care
A study testing nNO testing in people with Primary Ciliary Dyskinesia, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This is a study evaluating the utility of current Primary Ciliary Dyskinesia (PCD) diagnostic tests, including nasal nitric oxide testing. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Primary Ciliary Dyskinesia
- What is being tested?
- nNO testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Referred to center for PCD diagnosis considerations
- Ability to perform study procedures
- Age greater than 2 years of age
Who cannot join
- Age less than 2 years of age Inability to perform informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt Children's hospital
Nashville, Tennessee, 37232
Michael O'Connor, MD
About this study
This is a study evaluating the utility of current Primary Ciliary Dyskinesia (PCD) diagnostic tests, including nasal nitric oxide testing.
Read the detailed description
This study is a prospective data collection of individuals referred to the investigators clinical center for considerations of PCD. Participants sign informed consent to have clinical information entered into a secure electronic database. As part of this study, participants may have nasal nitric oxide (nNO) testing performed. nNO testing is a research procedure, but it is a test with growing utility for making a diagnosis of PCD when performed in the right clinical setting.
- Conditions
- Primary Ciliary Dyskinesia
- Being tested
- nNO testing
- Medical subject headings
- Ciliary Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nNO testingOther
Collection of already performed clinical data and nNO testing
| Study group | Role | What they receive |
|---|---|---|
| Nasal Nitric Oxide testing and collection of clinical data | Other | Participants will have nNO testing is indicated. All participants in this study have some basic clinical data collected at time of enrollment. Participants with a confirmed diagnosis of PCD or in those participants with a working diagnosis of PCD in which ongoing nNO testing is performed have prospective data collection. Some participants have a confirmed diagnosis of PCD by genetics or ciliary biopsy at time of study entry and thus do not need nNO testing, but are followed prospectively with collection of basic clinical data Receives: Other: nNO testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of nNO tests performed
number of tests
Measured: 3 years
Frequency of genetic tests performed
number of tests
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Jun 2017
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Ciliary DyskinesiaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael O'Connor, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704207
- Sponsor's protocol ID
- IRB #160951
- Status last verified
- Jun 2026
- First submitted
- 8 Oct 2018
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of PCD Diagnostics to Improve Clinical Care
- ClinicalTrials.gov ID
- NCT03704207
- Acronym / sponsor ID
- IRB #160951
- Conditions
- Primary Ciliary Dyskinesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study evaluating the utility of current Primary Ciliary Dyskinesia (PCD) diagnostic tests, including nasal nitric oxide testing.
Detailed description
This study is a prospective data collection of individuals referred to the investigators clinical center for considerations of PCD. Participants sign informed consent to have clinical information entered into a secure electronic database. As part of this study, participants may have nasal nitric oxide (nNO) testing performed. nNO testing is a research procedure, but it is a test with growing utility for making a diagnosis of PCD when performed in the right clinical setting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal Nitric Oxide testing and collection of clinical data | Other | Other: nNO testingParticipants will have nNO testing is indicated. All participants in this study have some basic clinical data collected at time of enrollment. Participants with a confirmed diagnosis of PCD or in those participants with a working diagnosis of PCD in which ongoing nNO testing is performed have prospective data collection. Some participants have a confirmed diagnosis of PCD by genetics or ciliary biopsy at time of study entry and thus do not need nNO testing, but are followed prospectively with collection of basic clinical data |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Referred to center for PCD diagnosis considerations
- Ability to perform study procedures
- Age greater than 2 years of age
Key exclusion criteria (1 listed)
- Age less than 2 years of age Inability to perform informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nNO testingCollection of already performed clinical data and nNO testing | Other | Nasal Nitric Oxide testing and collection of clinical data |
Primary outcome
frequency of nNO tests performed
Time frame: 3 years
number of tests
Frequency of genetic tests performed
Time frame: 3 years
number of tests
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nNO testing in people with Primary Ciliary Dyskinesia, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael O'Connor, MD (615.343.7617, michael.g.oconnor@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of nNO tests performed (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.