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NIOX VERO Nasal Application in Primary Ciliary Dyskinesia

NCT02622061 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 163

Last updated 2017-05-15

No results posted yet for this study

Summary

This is a multi-centre, single visit clinical investigation involving patients with known PCD vs. age matched healthy volunteers. This study involves 1 visit which will last one (1) to two (2) hours. Participants (and parent as applicable) will be asked for their consent to participate in the study. A brief medical history will be recorded, including information such as age, gender, height, weight, race, current medications and living environment. If the participant is a PCD patient, they will also be asked about their disease history. Prior to performing the nasal measurements, participants will receive instructions from study personnel and have the opportunity to practice. All participants will have a brief nasal exam and will also have to blow their nose before starting the measurements. Participants will be asked to perform nasal nitric oxide measurements using the tidal breathing method followed by the velum closed with expiration against resistance method.

The primary objective is to determine the feasibility and capability of the NIOX VERO to discriminate participants with PCD from those that are healthy. Information collected in this study will help researchers understand more about the diagnosis of and identification of patients with PCD.

Conditions

  • PCD

Sponsors & Collaborators

  • Aerocrine AB

    lead INDUSTRY

Principal Investigators

  • Kathy Rickard, MD · Aerocrine AB

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-10-31
Completion
2017-04-28

Countries

  • United States
  • Denmark
  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02622061 on ClinicalTrials.gov