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Normal Values of Nasal Nitric Oxide in Healthy AdultsNCT02133547

Determination of Normal Values of Nasal Nitric Oxide in Adults

An observational study of Normal Values of Nasal Nitric Oxide in Healthy Adults, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
How many people
200 participants
Where
1 siteSwitzerland
Study dates
Feb 2014to Apr 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: healthy subjects

Who may be able to join

  • consent signed
  • adult healthy subjects

Who cannot join

  • 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
Show all 10Show fewer
  • cleft palate
  • history of uvulopharyngopalatoplasty
  • history of neuromuscular disorder
  • history of chronic respiratory disease, including cystic fibrosis and primary ciliary dyskinesia

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Respiratory Department Lausanne University Hospital

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

Official title: Determination of Normal Values of Nasal Nitric Oxide Measured With the NIOX MINO Analyzer in Adults: a Pilot Study

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).

Read more

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.
Keywords
Nitric Oxide, Nose, Healthy Volunteers, Kartagener Syndrome, Primary Ciliary Dyskinesia
Medical subject headings
Kartagener Syndrome, Ciliary Motility Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: sampling time: 45 seconds

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionDec 2014
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02133547
Sponsor's protocol ID
CHUV-PNE-nNO-01
Status last verified
Jul 2015
First submitted
7 May 2014
Last updated
28 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18257783
  • 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.

    PubMed 18444488
  • 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.

    PubMed 23437356
  • 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.

    PubMed 21413977

Questions about this trial

What is this clinical trial studying?

An observational study of Normal Values of Nasal Nitric Oxide in Healthy Adults, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

nitric oxide concentration in the air flowing through the nasal cavities (time frame: sampling time: 45 seconds). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02133547, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.

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