A Randomized, Open Label, Cross-over Scintigraphic Evaluation of Lung Deposition of Alpha1-Proteinase Inhibitor (Human) (A1-PI(H) Inhalation Solution) using Two Inhalation Modes of the I-neb® Nebulizer in Healthy Subjects and Subjects with Cystic Fibrosis
- Conditions
- Cystic FibrosisE84Cystic fibrosis
- Registration Number
- DRKS00000754
- Lead Sponsor
- CSL Behring
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 21
Inclusion criteria of healthy subjects:
• Forced expiratory volume measured in 1 second (FEV1) 90% predicted as defined by age, gender, and height [1].
Inclusion criteria of subjects with CF:
• Confirmed diagnosis of CF - one or more clinical findings consistent with CF and at least 1 of the following:
a) Sweat chloride = 60 mEq/L by quantitative pilocarpine iontophoresis test
b) A genotype with 2 identifiable mutations consistent with CF (?F508 homozygous OR 2 alleles known to cause a class I, II, or III mutation)
• FEV1 30% predicted as defined by age, gender, and height
• Current smoker or a smoking history of > 10 pack-years (e.g. 20 cigarettes/day for 10 years). A subject who has used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars or pipe tobacco) will be excluded.
• Any signs of chronic or acute hepatitis A, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection (negative serology test for HIV and viral hepatitis). In case of positive serology test for viral hepatitis, vaccination status or negative IgM should be available.
• Has an oxygen saturation (as measured by pulse oximetry) < 85% on room air
• Change of routine CF treatment 2-4 weeks before screening
• IgA deficiency subjects
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total lung deposition relative to filling dose.<br>(Day 1 and Day 5, Scintigraphic gamma camera scan)<br><br>
- Secondary Outcome Measures
Name Time Method