Poster presented at the Thoracic Society of Australia and New Zealand (TSANZ) Meeting in Melbourne, Australia, 2008:

AUTHORS:

Kate M. Hardaker1, Paola T. Espinel1, Adriana M. Cortés1, Helen K. Reddel1, Brett G. Toelle1, Adrian Barnett2, Gail Williams3, Guy B. Marks1

STUDY CENTRE:

1. Woolcock Institute of Medical Research, Sydney, NSW 2050, 2. Institute of Health and Biomedical Innovation; Queensland University of Technology, Kelvin Grove, QLD, 4059, 3. School of Population Health, University of Queensland, Herston, QLD 4006.

BACKGROUND:

• Daily peak expiratory flow (PEF) monitoring has been used in epidemiological studies to assess changes in lung function over time.
• The value of written PEF diaries has been questioned because of problems with completeness and validity.

AIM:

To compare the accuracy of stored electronic PEF data and written diary records in an epidemiological study of Australian children.

METHODS:

Participants:

• Children aged 7-11 years.
• Attending primary schools in VIC and QLD.
• Doctor or nurse diagnosis of asthma.
• Respiratory symptoms in the past 12 months.

Recruitment:

• Nationwide population based study.
• Parents of eligible children recruited by telephone.
• Diaries and electronic devices explained to parents and children during 20 minute meeting with research staff.

Electronic Peak Flow:

• Mini-Wright Digital, Clement Clarke, UK - electronic PEF device with digital readout.
• Stores highest session PEF with date and time.
• Participants not informed of storage capability of the device.
• Electronic PEF device posted back at end of study.
• Data from electronic PEF device was uploaded to study PC at study end.

Written Diary:

• Parent recorded child's PEF (x3), symptoms and medication use morning and evening for 4 weeks.
• Diaries posted back weekly and reviewed by telephone call from trained staff.

Analysis:

• Electronic data:
• Recordings between 5-11am and 6pm-12mn analysed.
• Values > 3SDs above child's mean excluded as artefactual.
• Written data:
• Highest written PEF of 3 calculated for each session.
• Comparison of written and electronic:
• Missing electronic PEF: written PEF but no corresponding electronic PEF.
• Discordant PEF: > 10L/min difference in written and electronic PEF.

RESULTS:

• 48 subjects, mean age 10 years, 46% girls.
• Mean of 25 (range 4-28) days available for analysis.
• 8% of electronic records were made outside time window.
• Overall, 35% of written entries had missing or discordant electronic PEF records.
• The proportion of missing electronic data increased over this short period of monitoring (Trend test p < 0.003).

CONCLUSION:

These findings imply that missing and discordant data is common when study participants are asked to record PEF results onto paper diaries. Errors increase with duration of monitoring.

Acknowledgements: Supported by: Australian Research Council and National Environment Protection Council of Australia

In this edition of Niche News we present an independent study comparing the clinical efficacy of the LiteAire disposable spacer to a nebuliser in the treatment of acute asthma in adult patients admitted to a New York Hospital Emergency Department.

This study shows that beta agonist delivery via MDI with the LiteAire disposable spacer for the management of acute asthma is as efficacious as nebulizer delivery.

This is a very relevant and important clinical comparison especially when we consider that with the exception of Children's Hospitals the use of nebulisers remains the mainstay of clinical practice for bronchodilator administration in the treatment of acute asthma and COPD in the majority of Australian Hospitals.

We do however recognise that spacer usage and spacer advocacy is common practice in respiratory outpatient clinics, pulmonary function laboratories, community health and increasingly so in respiratory and medical wards.

Following the release of the new TGA Guidelines (1) in July 2007 prohibiting the reprocessing of single patient-use items (including single patient-use spacers i.e. Volumatic spacer etc) there has been a gradual shift in practice towards the utilisation of the recently introduced disposable spacers and autoclavable spacers.

The LiteAire disposable spacer is a viable alternative and has significant advantages over the newly introduced Large Plastic Disposable Spacers as follows:

• Proven Clinical Efficacy of the LiteAire Spacer.
• Storage - Compared to the significant storage space required by Large Plastic Spacers the LiteAire Cardboard Dispenser Box holds 25 LiteAire Spacers and is the size of a tissue box.
• Disposal - The LiteAire spacer is made from recyclable cardboard and is fully recyclable whereas Large Disposable Plastic Spacers must be disposed of via Incineration.
• Ease of Use - Patients may have difficulty coordinating their inhaler technique with Large Volume Spacers versus Small Volume Spacers - this is particularly true in children and the elderly.
• Convenience - the LiteAire spacer is extremely portable and stores flat.

The LiteAire disposable spacer also has significant advantages over the newly introduced Autoclavable Spacers as follows:

• Proven Clinical Efficacy of the LiteAire Spacer.
• Costs - Besides the initial cost of purchasing Autoclavable Spacers there are also ongoing reprocessing costs averaging $4.60 per spacer including staff time (2).
• The cost of the LiteAire disposable spacer is $4.00 and the patient can continue to use the LiteAire spacer for up to 7 days in the hospital or at home.
• Storage Issues - the department or ward must purchase enough Autoclavable Spacers to meet their clinical needs and this will invariably take up valuable storage space.
• Preparation - Following the reprocessing of the Autoclavable Spacer (normally through CSSD or in a Commercial Dishwasher if available in the department) the spacer must be prepared for use in order to remove the static build-up resulting from the sterilisation process and the spacer must be primed before use.
• The LiteAire disposable spacer is ready to use immediately and requires no preparation or priming.
• Ongoing performance - the condition of the Autoclavable Spacer will invariably diminish over time with repeated reprocessing and it is unknown how this will affect the ongoing performance of the spacer.

For a complimentary evaluation of the LiteAire disposable spacer in your healthcare facility simply reply to this email or telephone our office on 1300 136 855.

References:

(1). Update on the regulation of the re-manufacture of single use medical devices - October 2006 - TGA Website 2008.

(2). Laboratory usage habits and delivered salbutamol dose of spacers available in Australia and New Zealand - Presented by Graham Hall, Respiratory Medicine, Princess Margaret Hospital and School of Paediatric and Child Health, University of Western Australia at the TSANZ Conference in Melbourne, April 2008.

Abstract presented at the American Thoracic Society (ATS) Meeting in Toronto, Canada, 2008:

Authors:

Sunil Dhuper MD, Alpana Chandra MD, Aziz Ahmed MD, Sabin Bista MD, Ajit Moghekar MD, Rajesh Verma MD, Cynthia Chong MD, Chang Shim MD, Hillel Cohen Dr. PH, Sonia Choksi MD

Study Centre:

Coney Island Hospital: 2601 Ocean Parkway, Brooklyn, NY, USA, 11235

Background:

Despite demonstration of equivalent efficacy of beta agonist delivery using MDI with spacer versus nebulizer in asthma patients, use of nebulizer remains the standard of practice.

We hypothesize that beta agonist delivery with MDI/ disposable spacer (LiteAire) combination is as effective and low cost alternative than nebulizer delivery for acute asthma.

Methods:

Prospective, randomized, double blinded, placebo controlled trial in the emergency department (ED) in 60 acute asthma patients.

Subjects were randomized to receive albuterol with MDI/spacer combination or nebulizer. The spacer group (N=29) received albuterol by MDI using LiteAire followed by placebo nebulization.

The nebulizer group (N=29) received placebo by MDI using LiteAire followed by albuterol nebulization. Peak flows, symptom scores and need for rescue bronchodilator were monitored.

Results:

Patients in the two randomized groups had similar baseline characteristics. The severity of asthma exacerbation, median peak flows, and symptom scores were not significantly different between the two groups.

The median improvement in peak flow was 120(75,180)L/min versus 120(80,155)L/min in the LiteAire and nebulizer groups, respectively (p= 0.56). The median improvement in the symptom score was 7 (5,9) versus 7(4,9) in the LiteAire and nebulizer groups, respectively (p= 0.78).

Conclusion:

Beta agonist delivery with MDI /spacer combination for management of acute asthma is an equally efficacious and more economical alternative to nebulizer delivery.

Note:The Full Article has been accepted for publication in The Journal of Emergency Medicine.

Abstract presented at the American Thoracic Society (ATS) Meeting in Toronto, Canada, 2008:

Authors:

Sunil Dhuper MD, Sanjay Arora MD, Aziz Ahmed MD, Alpana Chandra MD ,Cynthia Chong MD, Chang Shim MD, Hillel W. Cohen Dr. PH, Scott Foss, Sonia Choksi MD.

Study Centre:

North Central Bronx Hospital, 3424 Kossuth Avenue, Bronx, New York 10467. An Affiliate of The Albert Einstein College of Medicine

Introduction:

Despite tremendous variability in the number of MDI actuations (2-12) used in studies comparing beta agonist delivery via MDI/spacer and one unit dose ampule with a nebulizer, there is increasing literature support based on clinical trials for the use of 6 MDI actuations.

Materials and Methods:

To determine the total dose output, a test device was attached to a USP throat model feeding into a filter connected to a Michigan Instrument Dual Test Lung System. Particle size was determined using an Andersen 8-Stage Cascade Impactor (ACI) with USP throat.

Results:

The total dose output was found to be 175.9±27.0 micrograms for 6 actuations of albuterol delivered to a LiteAire Spacer via MDI versus 219.8±13.6 micrograms for a Misty Max 10 with T-piece.

The percent respirable fraction (defined as the total mass on plates # 3-7 indicating a size range of 4.7- 0.4 microns) was found to be 90.26±1.51% for LiteAire and 81.68±0.66% for the Misty Max 10 (p<0.001).

Discussion:

This study demonstrates that using the breath simulation technique there is no significant difference in the total dose output using 6 actuations of albuterol MDI spacer versus 1 unit dose of nebulizer albuterol.

Even though the difference in the respirable fraction between the two modes of delivery using ACI was significant, there was no difference in the total dose output in the effective respirable dose calculated using the breath simulation studies.

We also determined that the total dose deposition using ACI with the two modes of delivery was not significantly different and well in line with the method using the breath simulated techniques.

Conclusion:

When conducting a clinical efficacy study comparing MDI/Spacer and one unit dose of albuterol delivered via nebulization, we recommend using 6 albuterol MDI actuations with spacer as the in vitro dose outputs with the two modes are comparable.

We are pleased to advise the release of new EasyOne spirometer internal firmware and new EasyWare computer software with some enhanced features.

The new software allows you to save 8 pre and 8 post bronchodilator results (including all curves) in the EasyOne spirometer and these results can then be reviewed and the tests re-ranked (if required) at the completion of the testing session via the new EasyWare software.

This upgrade is available (compatible) only for EasyOne spirometers with Serial Number 50500 and above. You will find the Serial Number on the base of the EasyOne spirometer.

Should you wish to have your EasyOne spirometer and EasyWare software upgraded free of charge then please contact Niche Medical on telephone: 1300 136 855 or simply reply to this email.

Note: You need to own a previous version of the EasyWare software to qualify for a free EasyWare software upgrade or alternatively you can purchase the new EasyWare software.

Quick Tip: Whilst on the subject of the EasyOne spirometer I will take this opportunity to answer one of the most commonly asked questions we receive.

Question: When using the EasyOne spirometer (stand-alone - without a computer) how do I get back to the main menu to do another test without having to turn off the EasyOne spirometer?

Answer: Hold down the "0" Key (which is also the Escape Key) until you hear a beep and this will take you back to the previous menu. Depending upon where you are in the menu you may need to repeat this step once or twice until you are back in the main menu which begins with "Perfom Test" .

email: craig@nichemedical.com.au

phone: 1300 136 855

web: http://www.nichemedical.com.au