Normal Values of Nasal Nitric Oxide in Healthy Adults Clinical Trial
Official title:
Determination of Normal Values of Nasal Nitric Oxide Measured With the NIOX MINO Analyzer in Adults: a Pilot Study
| Verified date | July 2015 |
| Source | Centre Hospitalier Universitaire Vaudois |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Laws and standards |
| Study type | Observational |
Primary ciliary dyskinesia (PCD) is a rare genetic disorder characterized by impaired airway
mucociliary clearance leading to recurrent respiratory infections, bronchiectasis and
eventually respiratory insufficiency. Diagnosis of PCD is difficult and relies on complex
methods which are not widely available (1).
Nasal nitric oxide (nNO) is reduced in PCD patients as compared to normal subjects, and nNO
measurement has been proposed as a non-invasive screening tool for PCD. However, nNO
measurement techniques are not standardized and reference values are lacking (2, 3).
The NIOX MINO is a handheld analyzer developed for the non-invasive measurement of exhaled
NO (eNO) in asthmatics. Measurement of nNO with the NIOX MINO has been reported in only few
studies (4-6), which mainly compared the NIOX MINO with others NO analyzers. However, no
study attempted to establish reference values with the NIOX MINO in a large number of normal
subjects.
One critical issue in nNO measurement is to avoid contamination of nasal air by exhaled
alveolar air during nNO sampling. This can be obtained by either breath holding, or by a
breathing technique allowing soft palate closure during sampling, such as mouth breathing
again resistance. However, as sampling times with the NIOX MINO are long (2 minutes at a
flow of 2 ml/min, and 45 seconds at a flow of 5 ml/min), these techniques may be difficult
to apply.
In this pilot study, we will determine normal nNO values in 100 healthy men and women aged
20 to 70 years using 3 different breathing techniques:
1. breath holding during 45 seconds
2. mouth breathing through a fixed resistance (a straw), to create a small positive
pressure in the oropharynx during expiration only
3. mouth breathing through a continuous positive airway pressure (CPAP) apparatus, which
produces continuous soft palate closure during quiet spontaneous breathing, thus
allowing long sampling times for nNO measurement.
This study will allow: 1) to determine whether nNO can be reliably measured with the NIOX
MINO in adult normal subjects, 2) to identify the most reproducible breathing technique, 3)
to determine normal values of nNO as measured by the NIOX MINO, and 4) to explore possible
differences between genders and age groups.
References:
1. J.S.A. Lucas, W.T. Walker, C.E. Kuehni and R. Lazor. Primary ciliary dyskinesia. Eur
Respir Mon. 2011; 54: 201-217.
2. ATS/ERS Recommendations for Standardized Procedures for the Online and Offline
Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005. Am
J Respir Crit Care Med 2005; 171: 912‑30.
3. Marthin JK, Nielsen KG. Choice of nasal nitric oxide technique as first-line test for
primary ciliary dyskinesia. Eur Respir J 2011; 37: 559‑65.
4. Marthin JK, Nielsen KG. Hand-Held Tidal Breathing Nasal Nitric Oxide Measurement - A
Promising Targeted Case-Finding Tool for the Diagnosis of Primary Ciliary Dyskinesia.
PLoS ONE 2013; 8: e57262.
5. Weschta M, Deutschle T, Riechelmann H. Nasal fractional exhaled nitric oxide analysis
with a novel hand-held device. Rhinology 2008; 46: 23‑7.
6. Maniscalco M, Laurentiis G de, Weitzberg E, Lundberg JO, Sofia M. Validation study of
nasal nitric oxide measurements using a hand-held electrochemical analyser. Eur J Clin
Invest 2008; 38: 197‑200.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | April 2015 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - consent signed - adult healthy subjects Exclusion Criteria: - current smoker - history of asthma - history of acute or chronic sinusitis - history of nasal polyps - upper airway infection in the past 3 weeks - use of nasal corticosteroids in the past 3 weeks - cleft palate - history of uvulopharyngopalatoplasty - history of neuromuscular disorder - history of chronic respiratory disease, including cystic fibrosis and primary ciliary dyskinesia |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Respiratory Department Lausanne University Hospital | Lausanne | Vaud |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Vaudois |
Switzerland,
Maniscalco M, de Laurentiis G, Weitzberg E, Lundberg JO, Sofia M. Validation study of nasal nitric oxide measurements using a hand-held electrochemical analyser. Eur J Clin Invest. 2008 Mar;38(3):197-200. doi: 10.1111/j.1365-2362.2008.01907.x. — View Citation
Marthin JK, Nielsen KG. Hand-held tidal breathing nasal nitric oxide measurement--a promising targeted case-finding tool for the diagnosis of primary ciliary dyskinesia. PLoS One. 2013;8(2):e57262. doi: 10.1371/journal.pone.0057262. Epub 2013 Feb 20. — View Citation
Montella S, Alving K, Maniscalco M, Sofia M, De Stefano S, Raia V, Santamaria F. Measurement of nasal nitric oxide by hand-held and stationary devices. Eur J Clin Invest. 2011 Oct;41(10):1063-70. doi: 10.1111/j.1365-2362.2011.02501.x. Epub 2011 Mar 17. — View Citation
Weschta M, Deutschle T, Riechelmann H. Nasal fractional exhaled nitric oxide analysis with a novel hand-held device. Rhinology. 2008 Mar;46(1):23-7. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | nitric oxide concentration in the air flowing through the nasal cavities | The NIOX MINO is a handheld analyzer allowing determination of nitric oxide in an air sample. The sample is obtained non-invasively by breathing in the device through the mouth or nose. | sampling time: 45 seconds | No |