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Evaluate Efficacy and Safety of "Kamada-AAT for Inhalation" in Patients With AATD — InnovAATe  

Alpha 1-Antitrypsin Deficiency Clinical Trial

Official title:
A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of "Kamada-AAT for Inhalation" 80 mg Per Day in Adult Patients With Congenital Alpha-1 Antitrypsin Deficiency With Moderate and Severe Airflow Limitation (40% ≤ FEV1 ≤ 80% of Predicted; FEV1/SVC ≤ 70%)

Clinical Trial Summary

The current study population will consist of adult patients with congenital alpha-1 antitrypsin (AAT) deficiency who have moderate or severe airflow limitation (forced expiratory volume in 1 second 40% ≤ [FEV1] ≤ 80% of predicted) and FEV1/slow vital capacity [SVC] ≤ 70% and who have not experienced two or more moderate or one or more severe exacerbations of COPD during the past year. A total of 220 patients will be recruited, and after 4 weeks practice inhaling saline with the nebulizer, will be randomized 1:1 to inhale either 80 mg/day "Kamada-AAT for Inhalation" or a placebo with identical appearance. Patients will be treated for 104 weeks and then followed up for a further 26 weeks. Over this time there will be 13 visits to the clinical site and in addition the patients will be required to fill out a daily e-diary.

Clinical Trial Description

Individuals with a genetic deficiency of alpha-1-antitrypsin (AATD) are at a significantly increased risk (80-100%) of developing emphysema. This study is designed to administer a solution of AAT by nebulizer so that patients can inhale the drug instead of requiring infusions as in current treatment. A significant advantage of inhalation is that the AAT is directly transferred to the lungs, which is the site most in need of the protein. Previous results show that in addition to the added convenience, three times higher concentrations of AAT can be achieved in the lungs by inhalation than by intravenous infusions. To date, more than 220 patients have completed Inhalation studies for several indications. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04204252
Study type Interventional
Source Kamada, Ltd.
Contact
Status Recruiting
Phase Phase 3
Start date November 25, 2019
Completion date September 2027
View Details
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