Cystic Fibrosis E84
Conditions
Interventions
Group 1: 1st treatment visit: 77 mg 99mTc-Venticoll-CR002 I-neb® nebulizer in TBM.
2nd treatment visit: 77 mg 99mTc-Venticoll-CR002 I-neb® nebulizer in TIM.
Group 2: 1st treatment visit: 77 mg 99mTc-
Sponsors
CSL Behring
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total lung deposition relative to filling dose. (Day 1 and Day 5, Scintigraphic gamma camera scan) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Oropharyngeal deposition relative to filling dose of 99mTc-Venticoll-CR002 using the I-neb® nebulizer in TIM and in TBM. (Day 1 and Day 5, Scintigraphic gamma camera scan). - Intrapulmonary drug distribution expressed as central to peripheral ratio and as variance of pixel counts. (Day 1 and Day 5, Scintigraphic gamma camera scan). - Total lung deposition relative to emitted dose (ex-mouthpiece dose). (Day 1 and Day 5, Scintigraphic gamma camera scan). - Extrathoracic drug deposition relative to filling dose. (Day 1 and Day 5, Scintigraphic gamma camera scan). - Exhaled drug fraction relative to filling dose. (Day 1 and Day 5, Scintigraphic gamma camera scan). - Nebulizer residue relative to filling dose. (Day 1 and Day 5, Scintigraphic gamma camera scan). - Inspiratory and expiratory lung function (includes FEV1, MEF25-75%, FEV1/FVC, FVC, TV, ERV, IC and IVC before treatment and 2 hours (± 15 min) after the completion of the inhalation of 99mTc-Venticoll-CR002. (Day 1 and Day 5, Spirometry). | — |
Countries
Germany
Contacts
Public ContactThomas Meyer
Inamed GmbH
Outcome results
None listed