Recruiting

Nasal Nitric Oxide

Sponsor:

Arkansas Children's Hospital Research Institute

Code:

NCT05287022

Conditions

Primary Ciliary Dyskinesia

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

this study is aiming at learning more about primary ciliary dyskinesia (PCD) and tests that are used to diagnose this condition. One purpose of this study is to measure the level of nitric oxide in the nasal passages and examine how often the results correlate with other tests currently done to make the diagnosis.

Conditions

Primary Ciliary Dyskinesia

Study ID

NCT05287022

Start date

Jun 14, 2021

Status verified date

Jan, 2025

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Individuals who are diagnosed with Primary Ciliary Dyskinesia OR
  • Individuals with abnormal PCD diagnostics (abnormal ciliary biopsy or PCD genetics) OR
  • Individuals with unexplained bronchiectasis OR
  • Individuals undergoing PCD diagnostic testing (ciliary biopsy, PCD genetic testing) or concern based on clinical symptoms (at least two of the following):

  • Neonatal respiratory distress
  • Organ laterality defects
  • Year-round cough starting in first year of life or bronchiectasis on chest CT
  • Year-round nasal congestion starting in first year of life or pansinusitis
  • Multiple ear infections in the first two years of life with sequelae (e.g. ear tubes, chronic effusion, abnormal audiological exam)
  • History of recurrent pneumonias (at least 2 in one year or more than 3 at any time)
  • Ability to provide consent for participation in study by the participants or guardian
  • Ability to perform the test
  • Age >= 2 years of age

Exclusion Criteria:

  • Individuals who are unable to understand the requirements of the study.
  • Individuals (or guardians) who are unwilling to provide consent.
  • Individuals who are unable to complete the testing
  • Recent history of sinus surgery (within four weeks) or bloody nose (within one week) of testing (they can be included at a later date)
  • Patients who are currently being treated (within one week) with antibiotics for sinusitis or respiratory symptoms (they can be included at a later date)
  • Age <2 years of age

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Measuring nasal nitric oxide in comparison to ciliary biopsy and genetic testing for the diagnosis of PCD [ Time Frame: throughout the study, an average of 3 years ]

Central Contacts and Locations

Central contacts

Zena Ghazala, MD

5013641006zbghazala@uams.edu

Locations

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

More Information

Sponsor

Arkansas Children's Hospital Research Institute

Last update posted

Jan 30, 2025

Last verified

Jan, 2025

Keywords

  • nNO
  • Diagnosis
  • PCD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute on 2025-01-30.