Scientific & Performance Evidence

Innovative Medical Devices
flow-vu
AEROCHAMBER PLUS* FLOW-VU* Chamber
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aerobika
AEROBIKA* OPEP Device
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AEROECLIPSE* BAN* Nebulizer
AEROECLIPSE* BAN* Nebulizer
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Trudell Medical International has an enviable history of strong leadership in creating innovative medical devices that enhance the quality of life for people of all ages - all backed by science and clinical evidence.

The safety and efficacy of our devices are validated in numerous third-party clinical evaluations with different patient populations. The AEROCHAMBER PLUS* brand of chambers is the most studied brand of spacer; supported by hundreds of in-vitro and in-vivo studies and is listed in the prescribing instructions for most MDIs.

Use the tabs below to find the latest clinical information regarding our devices.

 

Why is an inhaler always together with an AEROCHAMBER PLUS* FLOW-VU* spacer?

Use of a spacer is a simple and effective way to help improve the use of your inhaler. Spacers help to ensure that your medicine reaches your lungs where it’s needed and limits the amount that ends up in the back of the throat1.

People who use a valved holding chamber (VHC) such as AEROCHAMBER PLUS* FLOW-VU* Chamber, with their inhaler have better control of their respiratory symptoms.2

To improve drug delivery, respiratory guidelines recommend the use of chambers when using metered dose inhalers or puffers in people of all ages.3,4

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AEROCHAMBER PLUS* FLOW-VU* Chamber

Relative Bioavailability of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Administered With and Without a Spacer: Results of a Phase I, Randomized, Crossover Trial in Healthy Adults

AEROCHAMBER* brand of chambers improve lung delivery by consistently delivering the intended dose, regardless of inhaler technique. A recent third-party pharmacokinetic study demonstrated that AEROCHAMBER PLUS* FLOW-VU* chamber optimizes lung delivery, even in healthy adults trained on correct technique.

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The Impact of Inhalation Delay on Lung Drug Delivery: Using Functional Respiratory Imaging to Compare Metered Dose Inhaler (MDI) and MDI + Valved Holding Chamber (VHC) Systems.

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Assessment of Potential Mouth / Throat Deposition and Lung Delivery of Suspension- and Solution-Formulated Inhaled Corticosteroid Formulations Delivered by Pressurized Metered Dose Inhaler without and with Valved Holding Chamber Using an Anatomic Adult Upper Airway.

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AEROCHAMBER2GO* Chamber

Results from a Patient Survey Following Introduction of a New Spacer Designed to Help Use ‘On the Go’.

This poster was presented at ERSC 2021

Rationale: Although spacers have been shown to minimize problems of poor inhalation technique and target pMDI delivery to the lungs, they are often left at home due to their size and appearance. This abstract reports a post launch survey assessing changes in on-the-go spacer use with the new AEROCHAMBER2GO* spacer device.

Conclusion: This initial post launch survey highlighted a substantial increase in use of spacer with pMDI ‘On the Go’. The spacer’s improved ease of use, carrying and appearance may well have contributed to the noted increased adherence. Use of AEROCHAMBER2GO* spacer should be considered for all patients requiring a reliever pMDI when ‘On the Go’.

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AEROCHAMBER2GO* Chamber

Results from a Patient Survey Following Introduction of a New Spacer Designed to Help Use ‘On the Go’.

This poster was presented at ERSC 2021

Rationale: Although spacers have been shown to minimize problems of poor inhalation technique and target pMDI delivery to the lungs, they are often left at home due to their size and appearance. This abstract reports a post launch survey assessing changes in on-the-go spacer use with the new AEROCHAMBER2GO* spacer device.

Conclusion: This initial post launch survey highlighted a substantial increase in use of spacer with pMDI ‘On the Go’. The spacer’s improved ease of use, carrying and appearance may well have contributed to the noted increased adherence. Use of AEROCHAMBER2GO* spacer should be considered for all patients requiring a reliever pMDI when ‘On the Go’.

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How does AEROBIKA* Work?

  • Drug free, natural airway clearance
  • Easy to use, clean and disinfect
  • Compatible with nebulizer therapy
  • Five resistance settings to adjust to each patient’s expiratory capacity
  • Backed by clinical evidence
  • Not Made or Manufactured with BPA, Natural Rubber Latex, Phthalates, Lead, or PVC

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AEROBIKA* OPEP Device

The AEROBIKA* Oscillating Positive Expiratory Pressure (OPEP) device is hand-held, easy-to-use, and drug-free. When the patient exhales through the device, intermittent resistance creates a unique pressure – oscillation dynamic, which expands the airways, helps move the mucus to the upper airways where it can be coughed out and may also aid in improved drug deposition.

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As patients with COVID-19 having chronic pulmonary diseases often have excessive airway secretions, expiration exercises should be performed in addition to general airway clearance exercises to facilitate sputum excretion and reduce the exhaustion due to coughing. In addition, auxiliary techniques, such as the application of oscillatory positive expiratory pressure (OPEP), can be utilized.

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Our results support that the Aerobika device utilization leads to an improved airflow, which in turn causes a shift in IAD and impacts the drug deposition patterns of the concomitant medication in patients with COPD.

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Patients receiving the Aerobika OPEP device, compared to the Acapella device, had lower rates of subsequent severe disease exacerbation and all-cause inpatient admission. This suggests that Aerobika OPEP device may be a beneficial add-on to usual care and that OPEP devices may vary in clinical effectiveness.

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A National Audit of the AEROBIKA* Oscillatory Positive Pressure Device When Used to Assist Airway Clearance for Those With Cystic Fibrosis, Bronchiectasis and COPD

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Features

Designed with patients in mind:

  • Green feedback button moves down as you inhale to encourage slow, deep breath
  • Mouthpiece can be removed and replaced with a mask
  • Exhalation Valve directs exhaled breath away from your face and eyes
  • Disassembles into just 4 parts for easy cleaning

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AEROECLIPSE* BAN* Nebulizer

A brief overview of 120 studies with approved nebulizer formulations (including solutions, suspensions and antibiotics) and a variety of novel formulations.

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Performance with commonly prescribed nebulizer formulations.

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Select AEROECLIPSE* XL BAN* Nebulizer for delivery of CF medications, with the added value of improved dosing consistency and low fugitive emissions.

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Select AEROECLIPSE* XL BAN* Nebulizer for delivery of bronchiectasis medications.

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1. McIvor RA et al. Optimizing the delivery of inhaled medication for respiratory patients: the role of valved holding chambers. Canadian Respiratory Journal 2018.

2. Levy ML et al. Asthma patients’ 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

3. Canadian Thoracic Society – 2010 Consensus Summary for children six years of age and over, and adults.

4. Global Initiative for Asthma 2020.