NIOX VERO Nasal Application in Primary Ciliary Dyskinesia
Research type
Research Study
Full title
A Clinical Investigation Determining the Discriminative Ability of the NIOX VERO NASAL to differentiate subjects with Primary Ciliary Dyskinesia from Healthy Controls
IRAS ID
198934
Contact name
Kathleen Rickard
Contact email
Sponsor organisation
Aerocrine AB
ISRCTN Number
ISRCTN17820010
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 20 days
Research summary
The surface of the airways (respiratory epithelium) is equipped with movable ‘cilia’ (small finger like structures) that move particles such as dust, pollen, bacteria by a moving. In patients with Primary Ciliary Dyskinesia (PCD), a genetic disorder, cilia are often abnormal and do not move properly. When the cilia do not move properly, the cleaning of the respiratory tract is affected, which can lead to infections. PCD is often not diagnosed or misdiagnosed because symptoms may overlap with other more common respiratory conditions, especially in children. Observational data suggests that early diagnosis and management of patients in a specialised PCD clinic may improve long-term lung function, by using a simple test to achieve early diagnosis.
Patients with PCD often have a lower ‘nitric oxide’ NO (naturally occurring gas made in the lungs) level than healthy patients. NIOX VERO, is hand-held nitric oxide analyser, it is non-invasive and a first-in-line tool which can be used in the diagnosis PCD. With its Nasal Adapter, it can measure the concentration of nitric oxide in air, blown out from the nose and may be used as a way of identifying patients with PCD. In this study we are looking at how well the nasal adapter measures the levels of nitric oxide blown out of the nose from participants with PCD compared to healthy controls.
This is a multi-centre, single visit clinical investigation involving patients with known PCD vs. age matched healthy volunteers. Participants will be asked to perform NO measurements using the ‘tidal breathing method’ (measure the total volume of air in the lungs) followed by the ‘velum’ (upper part of your mouth) closed with expiration against ‘resistance method’ (using different methods of measuring breathing)
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0245
Date of REC Opinion
13 Jun 2016
REC opinion
Further Information Favourable Opinion