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.
Study Type
OBSERVATIONAL
Enrollment
163
St Louis
St Louis, Missouri, United States
Chapel Hill
Chapel Hill, North Carolina, United States
Denmark
Copenhagen, Denmark
Paris
Paris, France
Germany
Münster, Germany
The primary endpoint will be the analysis of the means of the successful nNO measurements in Subjects with PCD as compared with Healthy Subjects in the Evaluable Population.
Time frame: After a single 1-2 hour visit
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