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Welcome to Niche Medical's Customer Newsletter - October 2012

This newsletter is designed to inform our customers of the latest information on our products and services.

We highly value your input and feedback and encourage you to send all feedback and comments to Craig Abud by simply replying to this email.

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Craig Abud, Niche Medical

EasyOne Pro LAB Outreach to Thursday Island

EasyOne Lab System

The EasyOne Pro LAB visited Thursday Island this week with the Indigenous Respiratory Outreach Care (IROC) Team from the Royal Children's Hospital in Brisbane.

Thursday Island, also known as TI or Waiben, is the administrative and commercial centre of the Torres Strait Islands. Thursday Island lies 39 kilometers north of Cape York Peninsula, Queensland in the Torres Strait with a population of 2,546.[1]

The portability of the EasyOne Pro LAB means that for the first time the IROC Team in addition to Spirometry will be able to perform DLCO measurements and a nitrogen Multi Breath Washout (MBW) for determination of FRC (Functional Residual Capacity) and LCI (Lung Clearance Index) in their patients.

The EasyOne Pro LAB recently received FDA Approval and has been chosen by Vertex Pharmaceuticals for an upcoming clinical trial in paediatric patients with cystic fibrosis.

1. Australian Bureau of Statistics (25 October 2007). "Thursday Island (Urban Centre/Locality)". 2006 Census QuickStats. Retrieved 25 June 2011

Management of Asthma in Pregnancy

Management of asthma in pregnancy guided by measurement of fraction of exhaled nitric oxide: a double-blind, randomised controlled trial. 1

Heather Powell, Vanessa E Murphy, D Robin Taylor, Michael J Hensley, Kirsten McCaffery, Warwick Giles, Vicki L Clifton, Peter G Gibson. Lancet 2011; 378: 983-90.

SUMMARY

Background: Asthma exacerbations during pregnancy are common and can be associated with substantial maternal and fetal morbidity. Treatment decisions based on sputum eosinophil counts reduce exacerbations in non-pregnant women with asthma, but results with the fraction of exhaled nitric oxide (FeNO) to guide management are equivocal. We tested the hypothesis that a management algorithm for asthma in pregnancy based on FeNO and symptoms would reduce asthma exacerbations.

Methods: We undertook a double-blind, parallel-group, controlled trial in two antenatal clinics in Australia. 220 pregnant, non-smoking women with asthma were randomly assigned, by a computer-generated random number list, before 22 weeks' gestation to treatment adjustment at monthly visits by an algorithm using clinical symptoms (control group) or FeNO concentrations (active intervention group) used to uptitrate (FeNO >29 ppb) or downtitrate (FeNO <16 ppb) inhaled corticosteroid dose. Participants, caregivers, and outcome assessors were masked to group assignment. Longacting B2 agonist and minimum dose inhaled corticosteroid were used to treat symptoms when FeNO was not increased. The primary outcome was total asthma exacerbations (moderate and severe). Analysis was by intention to treat. This study is registered with the Australian and New Zealand Clinical Trials Registry, number 12607000561482.

Findings: 111 women were randomly assigned to the FENO group (100 completed) and 109 to the control group (103 completed). The exacerbation rate was lower in the FENO group than in the control group (0·288 vs 0·615 exacerbations per pregnancy; incidence rate ratio 0·496, 95% CI 0·325-0·755; p=0·001). The number needed to treat was 6. In the FENO group, quality of life was improved (score on short form 12 mental summary was 56·9 [95% CI 50·2-59·3] in FENO group vs 54·2 [46·1-57·6] in control group; p=0·037) and neonatal hospitalisations were reduced (eight [8%] vs 18 [17%]; p=0·046).

Interpretation: Asthma exacerbations during pregnancy can be significantly reduced with a validated FeNO-based treatment algorithm.

Funding: National Health and Medical Research Council of Australia.

REFERENCE:

1. Heather Powell, Vanessa E Murphy, D Robin Taylor, Michael J Hensley, Kirsten McCaffery, Warwick Giles, Vicki L Clifton, Peter G Gibson. Management of asthma in pregnancy guided by measurement of fraction of exhaled nitric oxide: a double-blind, randomised controlled trial. Lancet 2011; 378: 983-90.

ATS Guideline - Interpretation of Exhaled Nitric Oxide

An Official ATS Clinical Practice Guideline: Interpretation of Exhaled Nitric Oxide Levels (FeNO) for Clinical Applications. 1

Raed A. Dweik, Peter B. Boggs, Serpil C. Erzurum, Charles G. Irvin, Margaret W. Leigh, Jon O. Lundberg, Anna-Carin Olin, Alan L. Plummer , D. Robin Taylor, on behalf of the American Thoracic Society Committee on Interpretation of Exhaled Nitric Oxide Levels (FeNO) for Clinical Applications.

THIS OFFICIAL CLINICAL PRACTICE GUIDELINE OF THE AMERICAN THORACIC SOCIETY (ATS) WAS APPROVED BY THE ATS BOARD OF DIRECTORS, MAY 2011.

SUMMARY

Background: Measurement of fractional nitric oxide (NO) concentration in exhaled breath (FeNO) is a quantitative, noninvasive, simple, and safe method of measuring airway inflammation that provides a complementary tool to other ways of assessing airways disease, including asthma. While FeNO measurement has been standardized, there is currently no reference guideline for practicing health care providers to guide them in the appropriate use and interpretation of FeNO in clinical practice.

Purpose: To develop evidence-based guidelines for the interpretation of FeNO measurements that incorporate evidence that has accumulated over the past decade.

Methods: We created a multidisciplinary committee with expertise in the clinical care, clinical science, or basic science of airway disease and/or NO. The committee identified important clinical questions, synthesized the evidence, and formulated recommendations. Recommendations were developed using pragmatic systematic reviews of the literature and the GRADE approach.

Results: The evidence related to the use of FeNO measurements is reviewed and clinical practice recommendations are provided.

Conclusions: In the setting of chronic inflammatory airway disease including asthma, conventional tests such as FEV1 reversibility or provocation tests are only indirectly associated with airway inflammation. FeNO offers added advantages for patient care including, but not limited to (1) detecting of eosinophilic airway inflammation, (2) determining the likelihood of corticosteroid responsiveness, (3) monitoring of airway inflammation to determine the potential need for corticosteroid,and (4) unmasking of otherwise unsuspected non-adherence to corticosteroid therapy.

REFERENCE

1. Raed A. Dweik, Peter B. Boggs, Serpil C. Erzurum, Charles G. Irvin, Margaret W. Leigh, Jon O. Lundberg6, Anna-Carin Olin, Alan L. Plummer, D. Robin Taylor, on behalf of the American Thoracic Society Committee on Interpretation of Exhaled Nitric Oxide Levels (FeNO) for Clinical Applications.An Official ATS Clinical Practice Guideline: Interpretation of Exhaled Nitric Oxide Levels (FeNO) for Clinical Applications. Am J Respir Crit Care Med Vol 184. pp 602-615, 2011.

Read the full ATS guidelines here

NIOX MINO - FeNO measurement

Niox Mino

Inflammation measurement with NIOX MINO offers personalised asthma management that can dramatically improve the treatment and care of your patients.

Several underlying diseases can present symptoms similar to asthma. Therefore, a correct diagnosis relies on establishing whether or not the patient is characterised by allergic airway inflammation.

Until recently, diagnostic devices have not been able to convey a complete clinical overview and clearly identify the underlying cause of the symptoms. Consequently, patients that are not suffering from asthma have received unnecessary or inadequate treatment. 1.

Patients with asthma symptoms due to allergic inflammation will respond favourably to inhaled corticosteroids, while those who are suffering from other airway disorders may not. 2,3.

Measuring exhaled NO (FeNO ) helps to eliminate the uncertainties and discrepancies that contribute to asthma morbidity and mortality, including incorrect diagnosis and poor adherence to treatment.

Nitric Oxide (NO) - a marker of inflammation. Monitoring asthma symptoms is important , but correct interpretation of the underlying inflammation determines the therapy. Measuring exhaled NO provides an immediate answer to three critical questions:

  1. Which patients with non-specific or multiple respiratory symptoms have allergic airway inflammation?
  2. Is the patient adhering and responding to the prescribed therapy?
  3. Has there been a change in allergen exposure?

NIOX MINO reveals:

  • Allergic inflammation of the airways. 4.
  • Whether the patient is compliant with anti-inflammatory therapy. 6.
  • Changes in allergen exposure. 6.

Features:

  • Calibration and Maintenance-free instrument.
  • Validated against the Gold Standard Laboratory Instruments (Chemiluminescence). 7,8,9
  • All FeNO-values quality assured.
  • Validated repeatability means you only need perform a single measurement whereas other devices require at least two measurements. 10
  • Inhalation of NO-free air. NIOX MINO removes ambient NO, which ensures accuracy and follows the recommendations by ATS/ERS.
  • Instrument memory of up to 3000 measurements which can easily be transferred to the NIOX MINO Data Management Program on a PC.
  • Infection control with a disposable bacterial and viral filter prevents contamination of the device and between patients.

REFERENCES

1. Aaron SD, Vandemheen KL, Boulet LP, McIvor RA, Fitzgerald JM, Hernandez P, Lemiere C, S Harma S, Field SK, Alvarez GG, Dales RE, Doucette S, Fergusson D; Canadian Respiratory Clinical Research Consortium, Overdiagnosis of asthma in obese and nonobese adults. CMAJ. 2008. 18;179(11):p. 1121-31.

2. Berry, M.A., D.E. Shaw, R.H. Green, C.E. Brightling, A.J. Wardlaw, and I.D. Pavord, The use of exhaled nitric oxide concentration to identify eosinophilic airway inflammation: an observational study in adults with asthma. Clin Exp Allergy, 2005. 35(9): p. 1175-9.

3. Smith, A.D., J.O. Cowan, K.P. Brassett, S. Filsell, C. McLachlan, G. Monti-Sheehan, G . Peter Herbison, and D. Robin Taylor, Exhaled nitric oxide: a predictor of steroid response. Am J Respir Crit Care Med, 2005. 172(4): p. 453-9

4. Sandrini A, Taylor DR, Thomas PS, Yates DH, Fractional exhaled nitric oxide in asthma: an update. Respirology. 2010;15(1): p: 57-70.

5. S Zefler, S.J., H. Mitchell, C.A. Sorkness, P.J. Gergen, G.T. O'Connor, W.J. Morgan, M. Kattan, A. Pongracic, S.J. Teach, G.R. Bloomberg, P.A. Eggleston, R.S. Gruchalla, C.M. Kercsmar, A.H. Liu, J.J. Wildfire, M.D. Curry, and W.W. Busse, Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial. Lancet, 2008.372(9643): p. 1065-72.

6. Vahlkvist, S., M. Sinding, K. Skamstrup, and H. Bisgaard, Daily home measurements of exhaled nitric oxide in asthmatic children during natural birch pollen exposure. J Allergy Clin Immunol, 2006. 117(6): p. 1272-6.

7. K Alving, C Janson and L Nordvall. Performance of a new hand-held device for exhaled nitric oxide measurement in adults and children. Respiratory Research 2006, 7:67.

8. B. Khalili, P.B. Boggs, S.L. Bahna. Reliability of a new hand-held device for the measurement of exhaled nitric oxide. Allergy 2007: 1171-1174.

9. Daniel Menzies; Arun Nair and Brian J. Lipworth. Portable Exhaled Nitric Oxide Measurement. Comparison with the "Gold Standard" Technique. CHEST 2007; 131:410 - 414.

10. Kirsty M. Kapande, Laura A. McConaghy, Isabella Douglas, Sonia McKenna, Jenny L. Hughes, David R. McCance, Madeline Ennis and Michael Shields. Comparative Repeatability of Two Handheld Fractional Exhaled Nitric Oxide Monitors. Pediatric Pulmonology 2011.

 

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