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Published on Thursday, September 12, 2019

The biological effects of double-dose alpha-1 antitrypsin augmentation therapy: A pilot clinical trial

The biological effects of double-dose alpha-1 antitrypsin augmentation therapy: A pilot clinical trial

The American Journal of Respiratory and Critical Care Medicine, of the American Thoracic Society (ATS), recently published an article about the outcomes of a clinical trial entitled: “Effect of Double Dose of Alpha 1-antitrypsin Augmentation Therapy on Lung Inflammation,” conducted by Michael Campos, MD, of the University of Miami.

Augmentation therapy with intravenous alpha-1 antitrypsin (AAT) is the only specific therapy for individuals with pulmonary disease from Alpha-1 Antitrypsin Deficiency (AATD). The recommended standard dose elevates AAT trough serum levels to around 50% of normal; however, outside of slowing emphysema progression, its effects in other clinical outcomes have not been rigorously proven.

The objectives of this study were to evaluate the biological effects of normalizing AAT trough levels with double-dose (DD) therapy in subjects with AATD already receiving standard-dose (SD) therapy.

The conclusions of the study found that subjects with AATD on SD augmentation therapy still exhibit inflammation, protease activity, and elastin degradation that can be further improved by normalizing AAT levels. Higher AAT dosing than currently recommended may lead to enhanced clinical benefits and should be explored further.

This study describes the effects of double-dose AAT therapy on several biological parameters associated with the development and progression of AATD-related chronic obstructive pulmonary disease (COPD). Overall, double-dose therapy was shown to restore serum AAT levels to greater than 25 μM and to further reduce circulating and airway levels of serine proteases, reduce elastin degradation in the lung, and diminish airway inflammation in subjects already receiving standard-dose therapy. Therefore, increasing AAT levels into the normal range may provide additional clinical benefits and have a more robust impact on clinical outcomes in subjects with AATD requiring augmentation therapy.

You can read the complete article by the American Journal of Respiratory and Critical Care Medicine, on the ATS Journals website, by clicking here.

This clinical trial is registered with ClinicalTrials.gov (NCT 01669421).

Sources: American Journal of Respiratory and Critical Care Medicine, ClinicalTrials.gov


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