Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Grifols Therapeutics LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18 years or older.
Documentation of CF diagnosis.
Have a pre-bronchodilator FEV1 ≥ 40% of predicted at Visit 1 and have a Visit 2 pre-investigational product FEV1 that is ≥ 40% of predicted and within ± 15% of the Visit 1 result.
Deemed by the Investigator to be a suitable candidate for serial collection of expectorated sputum.
You may not be if
Had a pulmonary exacerbation during the 4 weeks before screening (Visit 1) which required the initiation of new antibiotic treatment
Have a pulmonary exacerbation during the screening period (between Visit 1 and Visit 2) which requires the initiation of new antibiotic treatment
FEV1 \< 0.59 liters at the screening visit
Respiratory insufficiency with continuous supplemental oxygen therapy, or carbon dioxide retention
Elevated aspartate transaminase (AST) or alanine aminotransferase (ALT) that is ≥ 3 times the upper limit of normal for age and gender
Smoking during the past 6 months
Lung surgery during the past 2 years
Positive culture for Burkholderia cepacia or mycobacterium during the past two years.
Active allergic bronchopulmonary aspergillosis
Pre-treatment sputum collection at Visit 1 or Visit 2 (Randomization) characterized by problems such as inadequate sputum volume or quality.
Known selective Immunoglobulin A (IgA) deficiency with known antibody against IgA (anti-IgA antibody).
History of anaphylaxis or severe systemic response to any plasma-derived alpha1-proteinase inhibitor preparation or other blood product(s), or to polysorbates.
Use of chronic oral steroids during the study. Note: Inhaled corticosteroids that had been administered for at least 4 weeks prior to Visit 1 were permissible during the study.
Use of chronic, high dose ibuprofen therapy within 3 weeks of screening and at anytime during the study.
Chronic maintenance therapy with systemic antibiotics within 3 weeks of screening and through last dose of investigational product.
Use of leukotriene synthesis inhibitor (zileuton) or leukotriene receptor antagonists (montelukast, zafirlukast) within 3 weeks of screening and at anytime during the study.
Use of roflumilast within 3 weeks of screening and at any time during the study.
Initiation of a new chronic medication or dosage change of a chronic medication for treatment of cystic fibrosis (example: Kalydeco™ \[ivacaftor\]) within 3 weeks of screening (Visit 1).
