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COPD (Chronic Obstructive Pulmonary Disease)

Interbroncial valve therapy

07/02/2009

Question:

A recent news broadcast 06/09 contained information about a trial for severe emphasyma patients where a small one way valve was placed in the airway leading to the most effected 5 or 6 areas of the lung. The device is made by a firm in Redmond, Wash state. I was rejected as being to old (76)to participate in the study leading to posible FDA approval by next summer. What can you tell me about the procedure and is there a way to obtain such a device before FDA approval is complete.?

Answer:

I believe the trial you are referring to is sponsored by "Spiration". Patients with upper lobe predominant emphysema based on CAT scan are selected to undergo several baseline pulmonary function tests and exercise tests. If they qualify, they would have a bronchoscopy and have placement of one-way valves strategically in the upper lobe airways to prevent air from getting in while allowing secretions to get out. The hypothesis is that preferential distribution of air to the lower lobes (where there is less emphysema) improves lung function and exercise tolerance. The current trial is "placebo controlled" - so only half of the subjects get the valves during the bronchoscopy.

I am not aware that you can get the valves outside of this trial. The FDA is likely awaiting the trial results prior to approval. It is possible that the valves may not really be that beneficial. The current study is being done to test their overall effectiveness.

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Response by:

Mahasti   Rittinger, RRT Mahasti Rittinger, RRT
Clinical Program Manager of Pulmonary, Allergy, Critical Care & Sleep
College of Medicine
The Ohio State University