Primary endpoint: whole lung deposition and in-vivo distribution pattern of a 99mTc-labelled tiotropium powder formulation following inhalation via HandiHalerTM in healthy subjects as well as in patients with mild, moderate and severe COPD Secondary endpoints: pharmacokinetics, pharmacodynamics (effect on lung function), safety and tolerability
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Percentage of the total administered radioactivity of 99mTc-labelled tiotropium
Time frame: Day 15
Peak plasma concentration at steady state (Cmax,ss)
Time frame: Day 14
Time to peak plasma concentration at steady state (Tmax,ss)
Time frame: Day 14
Pre-dose plasma concentration (Cpre)
Time frame: Day 1
Area under the curve from 0 to 4 hours at steady state (AUCss,0-4h )
Time frame: Day 14: 5, 10, 20 min, 1, 2, 4 hours after dosing
Renal clearance (CLr)
Time frame: Day 14: 0-4 hours and 4-8 hours after drug administration
Drug concentration (C20min)
Time frame: Day 15: 20 min after drug administration
Drug concentration (C2h)
Time frame: Day 15: 2 hours after drug administration
Change from baseline in forced expiratory volume in the first second (FEV1) in healthy subjects
Time frame: Baseline (day -14), day 15 (pre-dose)
Change from baseline in forced Vital Capacity (FVC) in healthy subjects
Time frame: Baseline (day -14), day 15 (pre-dose)
Number of adverse events
Time frame: up to day 38
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change from baseline in puls rate
Time frame: Baseline, day 28
Change from baseline in blood pressure
Time frame: Baseline, day 28
Change from baseline in laboratory tests
Time frame: Baseline, day 28
Change from baseline in 12 lead electrocardiogram (ECG)
Time frame: Baseline, day 28
Change from baseline in physical examination
Time frame: Baseline, day 28
Change from baseline in forced expiratory volume in the first second (FEV1) in COPD patients
Time frame: Baseline (day -14), pre-dose on day 1, 9, 14 (pre-dose and 0.5, 1, 2, and 3 hours after dosing), 15 and 28
Change from baseline in forced Vital Capacity (FVC) in COPD patients
Time frame: Baseline (day -14), pre-dose on day 1, 9, 14 (pre-dose and 0.5, 1, 2, and 3 hours after dosing), 15 and 28
Pre-dose plasma concentration in steady state (Cpre,ss)
Time frame: day 9, 14, 15
Area under the curve from 0 to 8 hours at steady state (AUCss,0-8h )
Time frame: Day 14: 5, 10, 20 min, 1, 2, 4, 8 hours after dosing
Amount excreted into urine from 0 to 4 hours (Aess,0-4h)
Time frame: Day 14: 0-4 hours, day 15: 0-4 hours
Amount excreted into urine from 0 to 8 hours (Aess,0-8h)
Time frame: Day 14: 0-8 hours, day 15: 0-8 hours