- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03524066
Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF)
February 13, 2019 updated by: Fraunhofer-Institute of Toxicology and Experimental Medicine
Understanding the Lung Pharmacokinetics (PK) in Humans by Direct Sampling of Epithelial Lining Fluid (ELF) After Inhalation and Oral Administration of Model Drugs
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hannover, Germany, 30625
- Fraunhofer Institute for Toxicology and Experimental Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and female subjects, aged 18-50 years. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing. Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit). Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs (Intrauterine devices) or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
- Normal lung function with Forced Expiratory Volume in the first second (FEV1) predicted ≥ 80% and FEV1/Forced Vital Capacity (FVC) > 70%.
- Nonsmokers with a history of less than 1 pack year having been nonsmokers for at least the last five years
- Body mass index between 18 and 32 kg/m²
- Able and willing to give written informed consent.
Exclusion Criteria:
- Past or present disease, which as judged by the investigator, may affect the outcome of the study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, psychiatric disease, endocrine disease, infectious disease, inflammatory disease or pulmonary disease (including but not confined to asthma, tuberculosis, bronchiectasis or cystic fibrosis)
- Regular intake of any prescribed or over the counter medication. Exceptions include paracetamol for pain relief, oral contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements
- Clinically relevant history of allergy as judged by the investigator
- Intolerance or contraindications to medications applied as model drugs (e.g. hyperthyreosis) or for sedation during bronchoscopy
- Infections of the lower respiratory tract within 4 weeks before visit 1, visit 2, or visit 3. These patients can be rescreened starting from visit 1.
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function, or ECG at Visit 1, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate in the study
- History of drug or alcohol abuse
- Risk of non-compliance with study procedures
- Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Inhaled + Bronchoscopy
One-time Inhalation of Salbutamol 200 µg, Salmeterol 50µg and Fluticasone 500µg.
During two bronchoscopic procedures two pre-specified lung tissue sites (middle lobe and lingula) will be sampled.
Bronchoadsorption sample, bronchial brushing, mucosal biopsy, and bronchoalveolar lavage (BAL) samples will be taken from each site.
|
Salbutamol(200µg), Salmeterol (50µg) and Fluticasone propionate (500µg) by inhalation
Bronchoadsorption sample, bronchial brushing, mucosal biopsy, and BAL samples during bronchoscopy
|
EXPERIMENTAL: Systemic + Bronchoscopy
One-time Salbutamol (8 mg) and Propranolol (40mg) administered orally.
During two bronchoscopic procedures two pre-specified lung tissue sites (middle lobe and lingula) will be sampled.
Bronchoadsorption sample, bronchial brushing, mucosal biopsy, and BAL samples will be taken from each site.
|
Bronchoadsorption sample, bronchial brushing, mucosal biopsy, and BAL samples during bronchoscopy
Salbutamol 8mg M/R Tablet, Propranolol 40 mg administered orally
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum concentration of Salbutamol in the lung
Time Frame: change from baseline to 1 hour and 24,5 hours post dose
|
Maximum concentration of Salbutamol in samples from bronchoscopy (bronchoadsorption, bronchial brushing, mucosal biopsy, Bronchoalveolar lavage (BAL))
|
change from baseline to 1 hour and 24,5 hours post dose
|
Maximum concentration of Salmeterol in the lung
Time Frame: change from baseline to 1 hour and 24,5 hours post dose
|
Maximum concentration of Salmeterol in samples from bronchoscopy (bronchoadsorption, bronchial brushing, mucosal biopsy, Bronchoalveolar lavage (BAL))
|
change from baseline to 1 hour and 24,5 hours post dose
|
Maximum concentration of Fluticasone in the lung
Time Frame: change from baseline to 1 hour and 24,5 hours post dose
|
Maximum concentration of Fluticasone in samples from bronchoscopy (bronchoadsorption, bronchial brushing, mucosal biopsy, Bronchoalveolar lavage (BAL))
|
change from baseline to 1 hour and 24,5 hours post dose
|
Maximum concentration of Propranolol in the lung
Time Frame: change from baseline to 1 hour and 24,5 hours post dose
|
Maximum concentration of Propranolol in samples from bronchoscopy (bronchoadsorption, bronchial brushing, mucosal biopsy, Bronchoalveolar lavage (BAL))
|
change from baseline to 1 hour and 24,5 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum concentration of Salbutamol in plasma
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 Salbutamol in plasma samples
|
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
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 samples
|
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 Fluticasone in plasma
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 Fluticasone in plasma samples
|
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
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 samples
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 10, 2018
Primary Completion (ACTUAL)
December 31, 2018
Study Completion (ACTUAL)
December 31, 2018
Study Registration Dates
First Submitted
April 25, 2018
First Submitted That Met QC Criteria
May 11, 2018
First Posted (ACTUAL)
May 14, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 15, 2019
Last Update Submitted That Met QC Criteria
February 13, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 17-15 BROSO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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