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About InnovAATe Study
InnovAATe is a phase 3 clinical study testing the safety and effectiveness of inhaled Alpha 1 Antitrypsin (AAT) in adults with lung disease due to Alpha-1 Antitrypsin Deficiency.
This study is part of a clinical development program lead by KAMADA Ltd., the manufacturer of AAT for inhalation.
Participating in the study involves daily inhalation at home and periodic clinical evaluation at a medical institution.
What is inhaled AAT?
- Inhaled AAT is an investigational medicine. It contains Alpha-1 Antitrypsin protein as the active ingredient and is delivered directly to the lungs through a specialized nebulizer at home.
- Administration of inhaled AAT aims to replace the deficient AAT protein in the lung of patients with severe AAT deficiency.
- Inhalation is a convenient, non-invasive, and widely used therapeutic approach to deliver
medicines directly to the lungs.
Who can participate in the InnovAATe study?
This is only a selection of the key inclusion and exclusion criteria.
There are additional requirements which can be reviewed and explained by the study doctor.
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You may qualify for the InnovAATe study if you are:
- Between the ages of 18 to 65 years
- Have a deficiency genotype of PiZZ, PiZ/Null or Pi(Null/Null);
- Serum Alpha-1 Antitrypsin levels below 11 μM (micro molar);
- Have lung disease with evidence of airflow limitation;
- Your post-bronchodilator FEV1% is between 40 and 80 percent of predicted.
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Subjects who may not be able to participate:
- IgA Deficiency.
- A history of life-threatening transfusion reaction(s), allergy, anaphylactic reaction, or systemic response to human plasma derived products.
- Have had a lung or liver transplant.
- Are currently smoking or have smoked in the past year.
Evaluate your potential eligibility for the InnovAATe study