November 30, 2017

Landmark asthma study demonstrates device choice determines asthma control

A landmark real-world study of more than 18,000 patients has demonstrated superior asthma control with the AeroChamber Plus* Flow-Vu* antistatic Valved Holding Chamber (VHC, or spacer) compared with other chamber devices.1 For those with asthma, particularly children, the choice of device to deliver their medication is an important consideration; even with the same metered-dose inhaler (MDI), not all valved holding chambers perform equally well.2 According to the study published in Pulmonary Therapy, the AeroChamber Plus* Flow-Vu* antistatic chamber was associated with delayed time to first exacerbation, fewer asthma related emergency department visits, and lower exacerbation-related costs than control chambers.

Asthma is a common respiratory condition which affects more than 3 million people in Canada, and it is the most common chronic disease among children and a leading cause of hospitalizations. 3,4 In Canada there were more than 70,000 emergency room visits due to asthma attacks in 2016.5 Mortality is high, 250 Canadians die each year from asthma and almost all of these deaths are preventable.6 Inhalation is the recommended route of administration for asthma medications; it provides direct targeting of drug to the lungs, and side effects are reduced compared with systemic medications. Inhaled corticosteroids (ICS) and bronchodilators administered by MDIs are the mainstay of long-term asthma treatment, the goals of which are to improve symptoms and prevent the occurrence of exacerbations.7 Unfortunately, poor inhaler technique is common, resulting in less of the delivered drug reaching the lungs, with much of it being deposited on the back of the throat and then swallowed.8 It has been found 9 out of 10 Canadians with asthma don’t have their symptoms under control.9 Between 28% and 68% of patients do not use their inhalers well enough to benefit from the prescribed medication. In addition, 25% of all expenditure on inhalers is wasted due to poor inhaler technique.10

Global respiratory guidelines recommend the use of chambers to improve MDI drug delivery.7 The Canadian Thoracic Society and Canadian Paediatric Asthma Consensus Guidelines state the addition of a chamber is recommended and helpful.11,12 Studies indicate that patients who use a chamber with their MDI have better asthma control than those using only a MDI.13 Chambers were designed to reduce the oropharyngeal deposition by changing the particle size distribution of the inhaled aerosol, and by holding the aerosol in the chamber until the patient is ready to inhale, which reduces the need for good coordination between inhalation and inhaler actuation.14 Effectiveness of these devices can be adversely affected by the design, including the chamber electrostatic charge, a commonly reported cause of inconsistent medication delivery.15

In this new study, Dr. Burudpakdee and colleagues compared the effects of the antistatic AeroChamber* Flow-Vu* VHC and control chambers on treatment outcomes, resource use, and healthcare costs in a real-world asthma population.1 Over 18,000 patients were included from an adjudicated claims database containing medical and pharmacy claims for more than 150 million US health plan members.1 The analysis showed that amongst patients with at least 30 days of follow up, for those using the AeroChamber Plus* Flow-Vu* antistatic VHC time to first exacerbation was delayed, there were fewer asthma-related emergency room visits and exacerbation-related costs were lower when compared to those using the control (non-antistatic) chambers.1 A trend towards lower exacerbation rates per patient for the AeroChamber Plus* Flow-Vu* VHC was sustained throughout the 12 months of the study.1

“This landmark study using a large volume of real-world evidence generated from many thousands of patients shows the value of optimizing drug delivery in asthma management,” said Dr. Andrew McIvor, (Firestone Institute of Respiratory Health, St. Joseph's Healthcare, Hamilton ON and past chairman of the Asthma Committee of the Canadian Thoracic Society). “The reduction in exacerbation incidence among users of the AeroChamber Plus* Flow-Vu* chamber is particularly notable, because experiencing an exacerbation is a risk factor for future exacerbation events – and minimizing exacerbation risk is a key goal of treatment in the GINA guidelines.”

Co-author, Dr Jason Suggett (Group Director of Global Science and Technology, Trudell Medical International) said that the study also further supports the fact that chambers are not interchangeable. “The European Medicines Agency recommended in 2009 that development of a MDI should include the testing of at least one specific named chamber, and that any substitution must be supported by appropriate in vitro or clinical data demonstrating equivalence”, he commented. “We presented laboratory data at the recent Respiratory Drug Delivery Europe meeting2 that confirmed that not all chambers perform equally well with the same MDI, which underlines the importance of recognizing the impact and potential risks of substituting one device for another.”

 

About Trudell Medical International (TMI)

Trudell Medical International designs, develops, manufactures, and distributes a wide range of medical devices and is home to a Global Aerosol Lab and Research Center. From the flagship AeroChamber* brand of valved holding chamber (VHC) and the latest award-winning Aerobika* device, to custom designed products and systems, Trudell’s best-in-class respiratory management products have been sold in over 110 countries. Their efficacy has been validated in hundreds of peer-reviewed articles from various medical journals. Learn More 

About AeroChamber* brand of valved holding chambers (VHC), including the AeroChamber Plus* Flow-Vu* antistatic chamber

Developed in 1983 to address the needs of asthma and COPD patients having difficulty in taking their MDI medications correctly, the AeroChamber* brand of chamber has innovated continuously to improve patient ease of use and quality of life as well as clinical outcomes and healthcare system savings.

  • The AeroChamber Plus* is the global leading chamber brand, with safety and efficacy validated in numerous third party clinical evaluations amongst various patient populations; it is the chamber most recommended by leading MDI pharmaceutical companies.
  • AeroChamber Plus* Flow-Vu* chamber is an antistatic chamber designed to deliver the intended prescribed dose via the MDI, similar to using an MDI with perfect technique. An additional feature is the incorporation of the Flow-Vu* inhalation indicator for the care-giver to observe effective inhalation. A recent study showed that caregiver quality of life improved almost four-fold when using the AeroChamber Plus* chamber with the Flow-Vu* indicator versus the same chamber without the indicator.16 The Flow-Vu* indicator provides real time feedback confirming an effective inhalation and ensures that there are no leakages of ambient air into the space between facemask and face, that could prevent medication delivery altogether.

Learn More

About the Study

Data for over 18,000 patients with an asthma diagnosis were analysed from the QuintilesIMS Real-World Data Adjudicated Claims Database (PharMetrics Plus) between 1/2010 and 8/2015; 9,325 using the AeroChamber Plus* Flow-Vu* antistatic VHC and a propensity-matched comparison cohort of 9,325 non-antistatic VHCs. Exacerbation incidence rates (IR), time to first exacerbation using Kaplan-Meier survival analysis, occurrence of exacerbations, and healthcare resource use and costs were compared.

  • Exacerbation IR/100 person-days (95% CI) was significantly higher in the control device cohort than the antistatic chamber cohort (0.161 [0.150-0.172] vs.0.137 [0.128-0.147]); more patients in the antistatic chamber cohort remained exacerbation free.
  • 4,293 patients in each cohort were followed up for ≥12 months and during which there was a trend for patients in the antistatic VHC group to be less likely (10-12%) to experience an exacerbation. Fewer patients using the antistatic VHC had an ED visit compared with those in the control group (10.8% vs. 12.4%).
  • Exacerbation-related costs for the antistatic VHC cohort was 23%, 25%, 20%, and 12% lower than the control device cohort at 1, 6, 9, and 12 months, respectively.

 

See the full study

Download the infographic

 

 

For clinical inquiries, please contact:
Jason Suggett PhD, BPharm, MBA, MRPharmS
Group Director of Global Science and Technology

 

 

* trade-marks and registered trade-marks of Trudell Medical International © TMI 2017. All rights reserved.

References

1.Burudpakdee C, Kushnarev V, Coppolo D, Suggett J. A retrospective study of the effectiveness of the AeroChamber Plus® Flow-Vu® Antistatic Valved Holding Chamber for asthma control. Pulmonary Therapy. 2017. https://doi.org/10.1007/s41030-017-0047-1. Accessed July 14.
2. Nagel MW, Suggett JA. Equivalence evaluation of valved holding chambers (VHCs) with albuterol pressurized metered dose inhaler (pMDI). Respiratory Drug Delivery Europe; April 25-28, 2017, 2017; Nice, France.
3. Conference Board of Canada (2012), Cost Risk Analysis for Chronic Lung Disease in Canada.
4. Asthma Society of Canada. http://www.asthma.ca/adults/about/asthma_facts_and_statistics.pdf
5. Canadian Institute for Health Information: Asthma Emergency Department Visits: Volume and Median Length of Stay. 2014-2015.
6. Asthma Society of Canada. http://www.asthma.ca/adults/about/asthma_facts_and_statistics.pdf
7. Global Initiative for Asthma: Global strategy for asthma management and prevention, 2017 Available from: . http://ginasthma.org/2017-gina-report-global-strategy-for-asthma-management-and-prevention/ Accessed November 2017.
8. Price D, Bosnic-Anticevich S, Briggs A, et al. Inhaler competence in asthma: common errors, barriers to use and recommended solutions. Respiratory Medicine. 2013;107(1):37-46.
9. The Lung Association, Asthma Control in Canada Survey 2016
10. Fink JB, Rubin BK. Problems With Inhaler Use: A Call for Improved Clinician and Patient Education. Respir Care 2005;50(10):1360–74.
11. Becker A, Bérubé D, et al. Canadian Pediatric Asthma Consensus Guidelines, 2003 (updated to December 2004) JAMC. 2005; 173(6)
12. Lougheed, M D, Lemière C, et al. Canadian Thoracic Society Asthma Management Continuum – 2010 Consensus Summary for children six years of age and over, and adults
13. Levy ML, et al. Asthma patient’s inability to use a pressurized metered-dose inhaler (pMDI) correctly correlates with poor asthma control as defined by the Global Initiative for Asthma (GINA) strategy: a retrospective analysis. Prim Care Respir J. 2013; Dec;22(4):406-11
14. Lavorini F, Fontana GA. Targeting drugs to the airways: The role of spacer devices. Expert opinion on drug delivery. 2009;6(1):91-102.
15. Mitchell JP, Coppolo DP, Nagel MW. Electrostatics and inhaled medications: influence on delivery via pressurized metered-dose inhalers and add-on devices. Respiratory care. 2007;52(3):283-300.
16. Ammari WG, et al. Evaluation of asthma control, parents’ quality of life and preference between AeroChamber Plus and AeroChamber Plus Flow-Vu spacers in young children with asthma. J Asthma 2015; 52(3):301-7.