New Combination Respiratory Therapy for COPD Approved by FDA

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FDA approval, combo therapy

A new double-combination therapy that promotes lung expansion and airway clearance has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of people with lung diseases including chronic obstructive pulmonary disease (COPD) and asthma.

The therapy was developed by the Monaghan Medical Corporation  and combines two of their existing products — the VersaPAP and the Aerobika — into a single handheld inhaler device.

In patients with COPD, the lungs collapse — a phenomenon called atelectasis — and the air becomes trapped in the airways, meaning that when patients try to exhale, not all the air is expelled properly from the lungs.

On its own, the VersaPAP device works by creating a pressure difference, which allows the patient to increase the amount of air being inhaled and decrease the work of breathing. When the patient exhales, the additional amount of air present in the lungs helps to expand the airways, improve gas exchange (namely oxygen) in the lungs, and remove fluids from the lungs (mucociliary clearance).

The Aerobika device works by simultaneously delivering intermittent positive expiratory pressure and oscillations. It helps expand the lungs, keeping open weak or collapsed airways, while assisting normal mucociliary action.

Studies have shown that positive airway pressure can help lessen or reverse a complete or partial collapse of the lungs.

Monaghan’s new device combines both Aerobika and VersaPAP, a type of tandem therapy that uses the pressure differences created by both devices to maximize the expansion of the lungs, and increase the volume of air passing through the airways both at inhalation and exhalation, while also improving mucociliary clearance.

According to the company, this combo therapy optimizes the function of each device.

“Augmentation of maximum flow from the VersaPAP device creates airway expansion on inhalation, allowing for the patient to take in a larger breath. This, in turn, means the patient will have more air to exhale. Oscillations from the Aerobika OPEP [oscillating positive expiratory pressure] device are then maximized on exhalation to improve airway clearance and further lung expansion by the added resistance of both devices,” Monaghan states in a press release.

The device comes as a “plug-and-play” model that is low-cost, safe, and effective, according to the company. It is designed for patients who are in a hospital setting or at home.

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