LONDON, ON, June 15, 2017 /CNW/ - Trudell Medical International (TMI). -- Chronic Obstructive Pulmonary Disease (COPD) is a significant healthcare problem, with an estimated 384 million cases worldwide in 2010.1 Population aging is predicted to drive further growth, with one study forecasting a 150% increase in prevalence overall, and up to 220% in the 75 and over age group, between 2010 and 2030.2
"COPD is a growing and devastating disease and is a key focus area for TMI," commented Andrew Varghese, Vice President and General Manager. He added that "the company has a long and enviable history of creating innovative and superior products, supported by scientific evidence, with the goal of improving patient outcomes and reducing health system costs around the world. Because COPD is a chronic and progressive disease, management strategies need to take into account very different patient experiences. Our patient-centric approach, along with our willingness to listen to our customers and incorporate their feedback into our product development, has helped us make a contribution to Respiratory Care over the past 30 years of which we can be very proud. The last 18 months in particular have seen significant gains."
The Aerobika* device
Data on this award-winning device have been published in a number of peer-reviewed publications.
Significant improvements in the ease-in-bringing up sputum, forced vital capacity (FVC), quality of life and 6-minute walk distance have been shown in a randomized cross-over study that evaluated daily Aerobika* device use in COPD patients.3 HE MRI images also showed ventilation improvements (Svenningsen, et al. COPD 20163).
Based on evidence that up to 50% of patients with COPD also have associated bronchiectasis4 a study was undertaken in non-cystic fibrosis bronchiectasis patients to determine regional airway abnormalities with CT and MRI evaluations, as well as response to Aerobika* device use over 3 weeks. Use of the Aerobika* device resulted in clinically relevant improvement in symptoms, exercise capacity and quality of life (Svenningsen, et al. Academic Radiology, 20175).
A real-world study with over 800 COPD patients showed that treatment with the Aerobika* device reduced the recurrence of moderate-to-severe exacerbations by 28% and severe exacerbations by 27% in the crucial 30-day post exacerbation period, when used as an add-on to usual COPD medications (Burudpakdee ,et al. Pulmonary Therapy 20176).
AeroChamber Plus* Flow-Vu* antistatic valved holding chamber (AVHC)
As the makers of the leading global brand of chambers for use with Metered Dose Inhalers (MDIs), TMI is pleased to announce that a new Adult Small Mask has been added to the line of AeroChamber Plus* Flow-Vu* AVHC. The Adult Small Mask is specifically designed for adults with smaller facial dimensions. As more elderly women with comorbidities are being diagnosed with COPD, using an MDI with a chamber and mask is an easy to use and cost effective drug delivery system for this patient population.
AeroCount* Dose Counter (DC)
The metered dose inhaler (MDI) remains one of the most popular delivery devices for asthma and COPD medications, but one of the most difficult challenges for patients is knowing when to replace their inhaler. A recent study of over 93,000 patients found that the integration of a dose counter into rescue inhalers could decrease emergency department admissions due to exacerbations by 45%.7 Propellant may still fire from the MDI even when there is little or no drug left, leading patients to continue to use it without the clinical benefit. The presence of a dose counter can help avoid this by ensuring patients know when to replace their device.
The AeroCount* integrated DC was first approved by the US FDA in conjunction with Alvesco in 2008, becoming the first approved dose counter available for pharmaceutical developers. In the last year, the second generation mode of the AeroCount* DC (TMAI-200 model, Trudell Medical International) has been approved by the FDA in conjunction with two more MDI programs8. The addition of AeroCount* DC to an inhaler provides patients with reassurance that they will know when to replace their inhaler as well as reducing the risk of taking a sub therapeutic dose by using the inhaler past the label claimed number of doses.
AEROECLIPSE* Breath-Actuated Nebulizer (BAN)
Trudell is proud to continue a history of improvements to the treatment of COPD with the only breath actuated jet nebulizer. Over the last year the AEROECLIPSE* BAN was used in several studies focused on reducing healthcare costs and achieving better patient outcomes. In one study, it was shown that patients who received care from a Respiratory Therapist using the AEROECLIPSE* II BAN lowered the 30 day readmission rates from 13.6 to 6.1%, and reduced the number of patients that required rapid response treatements from 34.4 to 12.7%.9 In a separate study, after switching to the AEROECLIPSE* II BAN in the emergency department (ED) to treat COPD cases, admissions from ED to hospital decreased 66%.10 The study lead to standard of care changes that reduced costs while improving patient satisfaction.
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, our 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. www.trudellmed.com
About the Aerobika* device
The hand-held, easy-to-use, and drug-free device uses the patient's exhalation through the device to activate the proprietary mechanism which creates a pressure-oscillation dynamic within the lungs. This pressure-oscillation dynamic expands the airways, helps to expel the mucus to the upper airways where it can be coughed out and may also aid in improved drug deposition. The Aerobika* device is used in addition to current COPD treatments. www.aerobikaopep.com
About AeroChamber* brand valved holding chambers (VHC)
Developed in 1983 to address the needs of asthma and COPD patients having difficulty in taking their MDI medications correctly, AeroChamber* brand VHC has innovated continuously to improve patient ease of use and quality of life as well as clinical outcomes and healthcare system savings. The AeroChamber* brand VHC is the global leader of chambers, 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. www.aerochamber.com
About AeroCount* Dose Counter (DC)
Designed for developers of MDI products, the AeroCount* Dose Counter provides patients with a visual indication of remaining medication in their pressurized Metered Dose Inhaler (MDI).
About AEROECLIPSE* BAN
The world's only small volume jet nebulizer that is breath-actuated; it generates aerosol only in response to the patient's inspiratory flow. The BAN ensures virtually no drug is lost to the environment; it generates a high percentage of respirable medication particles to shorten delivery time, and may improve clinical outcomes.
* trade-marks and registered trade-marks of Trudell Medical International © TMI 2017. All rights reserved.
- Adeloye D, Chua S, Lee C, et al. Global and regional estimates of COPD prevalence: Systematic review and meta-analysis. Journal of global health. 2015;5(2):020415.
- Khakban A, Sin DD, FitzGerald JM, et al. The Projected Epidemic of Chronic Obstructive Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based Perspective. Am J Respir Crit Care Med. 2017;195(3):287-291.
- Svenningsen S, Paulin GA, Sheikh K, et al. Oscillatory Positive Expiratory Pressure in Chronic Obstructive Pulmonary Disease. COPD. 2016;13(1):66-74.
- Kosmas E. Bronchiectasis in patients with COPD: an irrelevant imaging finding or clinically important phenotype? Chest. 2016;150 ((4 S)):894A.
- Svenningsen S, Guo F, McCormack DG, Parraga G. Noncystic Fibrosis Bronchiectasis: Regional Abnormalities and Response to Airway Clearance Therapy Using Pulmonary Functional Magnetic Resonance Imaging. Academic radiology. 2017;24(1):4-12.
- Burudpakdee C, Seetasith A, Dunne P, et al. A real-world study of 30-day exacerbation outcomes in chronic obstructive pulmonary disease (COPD) patient managed with Aerobika OPEP. Pulmonary Therapeutics. 2017.
- Price DB, Rigazio A, Buatti Small M, Ferro TJ. Historical cohort study examining comparative effectiveness of albuterol inhalers with and without integrated dose counter for patients with asthma or chronic obstructive pulmonary disease. Journal of asthma and allergy. 2016;9:145-154.
- FDA. NDA 208294. 2016, and NDA 021730. 2017; https://www.accessdata.fda.gov/scripts/cder/daf/. Accessed May 17, 2017
- LaRoche KD, Hinkson CR, Thomazin BA, Minton-Foltz PK, Carlbom DJ. Impact of an Electronic Medical Record Screening Tool and Therapist-Driven Protocol on Length of Stay and Hospital Readmission for COPD. Respiratory care. 2016;61(9):1137-1143.
- Saunders D. Transitioning to a Breath-Actuated Pneumatic Nebulizer in the ED and In-patient Settings; Experienced Gained from Stakeholders Involved with the Process. Paper presented at: American Association of Respiratory Care Congress2015; Tampa, FL.
SOURCE Trudell Medical International
For further information: For clinical inquiries, please contact: Jason Suggett PhD, BPharm, MBA, MRPharmS, Group Director of Global Science and Technology