The aim of the present study is to increase the general understanding of lung PK of selected compounds by sampling epithelial lining fluid ELF and lung tissue.
This study will investigate drug levels of selected compounds at multiple sites in the lung and explore different innovative sampling methods to obtain information on lung PK. The aim of the study is not to generate safety or efficacy data of the selected licensed drugs. The choice of drugs is based on general considerations regarding therapy of airway diseases and the physical-chemical properties of the compounds. It is not driven by the compounds per se.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
21
Salbutamol(200µg), Salmeterol (50µg) and Fluticasone propionate (500µg) by inhalation
Salbutamol 8mg M/R Tablet, Propranolol 40 mg administered orally
Bronchoadsorption sample, bronchial brushing, mucosal biopsy, and BAL samples during bronchoscopy
Fraunhofer Institute for Toxicology and Experimental Medicine
Hanover, Germany
Maximum concentration of Salbutamol in the lung
Maximum concentration of Salbutamol in samples from bronchoscopy (bronchoadsorption, bronchial brushing, mucosal biopsy, Bronchoalveolar lavage (BAL))
Time frame: change from baseline to 1 hour and 24,5 hours post dose
Maximum concentration of Salmeterol in the lung
Maximum concentration of Salmeterol in samples from bronchoscopy (bronchoadsorption, bronchial brushing, mucosal biopsy, Bronchoalveolar lavage (BAL))
Time frame: change from baseline to 1 hour and 24,5 hours post dose
Maximum concentration of Fluticasone in the lung
Maximum concentration of Fluticasone in samples from bronchoscopy (bronchoadsorption, bronchial brushing, mucosal biopsy, Bronchoalveolar lavage (BAL))
Time frame: change from baseline to 1 hour and 24,5 hours post dose
Maximum concentration of Propranolol in the lung
Maximum concentration of Propranolol in samples from bronchoscopy (bronchoadsorption, bronchial brushing, mucosal biopsy, Bronchoalveolar lavage (BAL))
Time frame: change from baseline to 1 hour and 24,5 hours post dose
Maximum concentration of Salbutamol in plasma
Maximum concentration of Salbutamol in plasma samples
Time frame: change from baseline to 0,25 hour (h) 0,5 h, 1 h, 2 h, 4h, 8 h, 12 h, 24 h, 36 h, 48 h post dose
Maximum concentration of Salmeterol in plasma
Maximum concentration of Salmeterol in plasma samples
Time frame: change from baseline to 0,25 hour (h) 0,5 h, 1 h, 2 h, 4h, 8 h, 12 h, 24 h, 36 h, 48 h post dose
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Maximum concentration of Fluticasone in plasma
Maximum concentration of Fluticasone in plasma samples
Time frame: change from baseline to 0,25 hour (h) 0,5 h, 1 h, 2 h, 4h, 8 h, 12 h, 24 h, 36 h, 48 h post dose
Maximum concentration of Propranolol in plasma
Maximum concentration of Propranolol in plasma samples
Time frame: change from baseline to 0,25 hour (h) 0,5 h, 1 h, 2 h, 4h, 8 h, 12 h, 24 h, 36 h, 48 h post dose