The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone and Formoterol using a gamma-scintigraphic technique after inhalation of a single dose of 99mTc-radiolabelled BDP/formoterol fixed combination administered Via the NEXT DPI in healthy volunteers, asthmatic and COPD patients. Additionally, the systemic exposures to formoterol, BDP and its monopropionate metabolite (B17MP) will be investigated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Single inhalation of radiolabelled BDP/formoterol 100/6 µg NEXT DPI (4 puffs giving a total dose of 400 µg BDP + 24 µg formoterol)
Inamed Research GmbH & Co. KG
Gauting, Germany
Lung deposition of BDP and Formoterol (expressed as % of emitted dose) when inhaled using the NEXT dry powder inhaler
Calculated using the individual Gamma camera images and the regions of interest defined from the 81mKrypton-ventilation scan.
Time frame: Immediately after dosing
Distribution of lung deposition
Time frame: Immediately after dosing
Extrathoracic deposition
Time frame: Immediately after dosing
Exhaled activity
Time frame: Immediately after dosing
Plasma pharmacokinetics of formoterol, BDP and its monopropionate metabolite (B17MP)
Time frame: over 24 h post dose
Lung function parameters
Time frame: over 24 h post dose
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