Phase II, Safety and Efficacy Study of Kamada-alpha-1-antitrypsin (AAT) for Inhalation"

Exclusion Criteria

• •Clinically significant intercurrent illnesses (except for respiratory or liver disease secondary to AAT deficiency), including: cardiac, hepatic, renal, endocrine, neurological, hematological, neoplastic, immunological, skeletal or other) that in the opinion of the investigator, could interfere with the safety, compliance or other aspects of this study. Patients with well-controlled, chronic diseases could possibly be included after consultation with the treating physician and the sponsor.
• •History of life threatening allergy, anaphylactic reaction, or systemic response to human plasma derived products.
• •History of life threatening transfusion reactions.
• •History of lung transplant.
• •Current or previous (up to 8 weeks from baseline) use of AAT augmentation therapy or by any other route
• •Current use of oral or parenteral glucocorticoids in doses exceeding 10mg of prednisone daily or equivalent generics (substance and dose).
• •Any lung surgery within the past two years.
• •On any thoracic surgery waiting list.
• •Active smoking during the last 12 months from screening date.
• •Pregnancy or lactation.
• •Woman of child-bearing potential not taking adequate contraception deemed reliable by the investigator.
• •Presence of psychiatric/ mental disorder or any other medical disorder which might impair the patient's ability to give informed consent or to comply with the requirements of the study protocol.
• •Evidence of alcohol abuse or history of alcohol abuse or illegal and/or legally prescribed drugs.
• •Immunoglobulin A (IgA) Deficiency.
• •Inability to undergo bronchoscopy.
• •Allergy to lidocaine or any other medicines used in the bronchoscopy process
• •Exacerbation of chronic obstructive pulmonary disease (COPD) in the previous 6 weeks.
• •Participation in another clinical trial involving investigational medication or interventional treatment within 30 days prior to baseline visit.
• •Participation in observational clinical trial which involves any invasive procedure scheduled to occur during the AAT inhaled study period. If participating in an observational clinical trial that already completed all diagnostic procedures (e.g. liver biopsy), any adverse events (AEs) experienced must have returned to baseline within 30 days prior to baseline visit.
• •Inability to attend scheduled clinic visits and/or comply with the study protocol.
• •Any other factor that, in the opinion of the investigator, would prevent the patient form complying with the requirements of the protocol.