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Determination of Normal Values of Nasal Nitric Oxide in Adults

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ClinicalTrials.gov Identifier: NCT02133547
Recruitment Status : Completed
First Posted : May 8, 2014
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Romain Lazor, Centre Hospitalier Universitaire Vaudois

Brief 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).

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.

Condition or disease
Normal Values of Nasal Nitric Oxide in Healthy Adults

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determination of Normal Values of Nasal Nitric Oxide Measured With the NIOX MINO Analyzer in Adults: a Pilot Study
Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. nitric oxide concentration in the air flowing through the nasal cavities [ Time Frame: sampling time: 45 seconds ]
    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.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy subjects
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133547


Locations
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Switzerland
Respiratory Department Lausanne University Hospital
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Romain Lazor, MD Lausanne University Hospital (CHUV)

Publications:
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Responsible Party: Dr. Romain Lazor, MD, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02133547     History of Changes
Other Study ID Numbers: CHUV-PNE-nNO-01
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Keywords provided by Dr. Romain Lazor, Centre Hospitalier Universitaire Vaudois:
Nitric Oxide
Nose
Healthy Volunteers
Kartagener Syndrome
Primary Ciliary Dyskinesia
Additional relevant MeSH terms:
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Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents