<p>Dear Alpha-1 Research Registry Member, </p><p>We are contacting you to follow-up about a research study sponsored by KAMADA High Quality Pharmaceuticals. As you may know the current treatment for individuals who have been diagnosed with Alpha-1 deficiency is augmentation therapy. Augmentation therapy involves weekly infusions of the alpha-1 antitrypsin protein; and until other therapies become available it is considered ongoing and lifelong. This study will be looking at an inhaled form of the human Alpha- 1 antitrypsin (AAT) protein. This is a double-blind study of the daily use of “Kamada- API for inhalation” that will require approximately 8 visits to a study center. Double blind means that Alpha-1 antitrypsin deficient individuals with lung disease will be randomized to receive the study medication at one of two doses (80mg/day or 120 mg/day) or a placebo (a substance containing no study drug). Inhalation of the drug will be done at least once, but up to two times a day. Study procedures include a bronchoscopy at the beginning and end of the study period, blood tests, and physical exams.</p><p>Eligible participants must:  Be 18-65 years of age  Have a diagnosis of Alpha-1 deficiency- ZZ or ZNull (have an AAT level of less than 11 uM)  Not have any Alpha-1 augmentation therapy for at least 8 weeks before the first dose of study drug</p><p>Many exclusions to participation exist, including having had a lung transplant, or lung surgery within the last 2 years, current use of high dose steroids, active smoking within 12 months of screening visit, pregnancy, or a COPD exacerbation within 6 weeks of the screening visit. More of these will be explained to you when you contact a participating site. Travel reimbursement may be available through AlphaNet or the participating medical center, please ask the center you would like to visit for details. </p><p>There are 2 medical centers currently enrolling participants; University of Texas Health Science at Tyler and the University of Florida. Please see the enclosed letter for more detailed information. </p><p>To contact the University of Texas Health Science Tyler, please call 903-877-5518 or email Jan Hoeft at [email protected]. </p><p>To contact the University of Florida, please call 866-229-6312 or email Pam Schreck at [email protected] or Joanna Nolte at [email protected]. </p><p>Thank you for your consideration of this study and your participation in the Alpha-1 Research Registry. If you have any questions please feel free to respond to this email or call us toll free at 1-877-886-2383. </p><p>Sincerely, </p><p>Charlie Strange, M.D. Director, Alpha-1 Foundation Research Registry Professor, Medical University of South Carolina</p>