HealthyNCT03524066
Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF)
A study testing Inhalation, Systemic and Bronchoscopy in people with Healthy, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Inhalation, Systemic and Bronchoscopy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 10 Apr 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Fraunhofer Institute for Toxicology and Experimental Medicine
Hanover, 30625
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Inhalation, Systemic, Bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InhalationDrug
Salbutamol(200µg), Salmeterol (50µg) and Fluticasone propionate (500µg) by inhalation
SystemicDrug
Salbutamol 8mg M/R Tablet, Propranolol 40 mg administered orally
BronchoscopyOther
Bronchoadsorption sample, bronchial brushing, mucosal biopsy, and BAL samples during bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| Inhaled + Bronchoscopy | Experimental | 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. Receives: Drug: Inhalation; Other: Bronchoscopy |
| Systemic + Bronchoscopy | Experimental | 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. Receives: Drug: Systemic; Other: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration of Salbutamol in the lung
Maximum concentration of Salbutamol in samples from bronchoscopy (bronchoadsorption, bronchial brushing, mucosal biopsy, Bronchoalveolar lavage (BAL))
Measured: 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))
Measured: 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))
Measured: 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))
Measured: change from baseline to 1 hour and 24,5 hours post dose
Secondary outcomes (4)
Maximum concentration of Salbutamol in plasma
Maximum concentration of Salbutamol in plasma samples
Measured: 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
Measured: 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
Maximum concentration of Fluticasone in plasma samples
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start10 Apr 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Jens Hohlfeld, MD, Principal investigator, Fraunhofer ITEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524066
- Sponsor's protocol ID
- 17-15 BROSO
- Status last verified
- Feb 2019
- First submitted
- 25 Apr 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Lung Pharmacokinetics (PK) in Humans by Direct Sampling of Epithelial Lining Fluid (ELF) After Inhalation and Oral Administration of Model Drugs
- ClinicalTrials.gov ID
- NCT03524066
- Acronym / sponsor ID
- 17-15 BROSO
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled + Bronchoscopy | Experimental | Drug: Inhalation, Other: BronchoscopyOne-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. |
| Systemic + Bronchoscopy | Experimental | Drug: Systemic, Other: BronchoscopyOne-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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InhalationSalbutamol(200µg), Salmeterol (50µg) and Fluticasone propionate (500µg) by inhalation | Drug | Inhaled + Bronchoscopy |
| SystemicSalbutamol 8mg M/R Tablet, Propranolol 40 mg administered orally | Drug | Systemic + Bronchoscopy |
| BronchoscopyBronchoadsorption sample, bronchial brushing, mucosal biopsy, and BAL samples during bronchoscopy | Other | Inhaled + Bronchoscopy, Systemic + Bronchoscopy |
Primary outcome
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))
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))
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))
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))
4 secondary outcomes
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 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 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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Hohlfeld, MD principal investigator
Fraunhofer ITEM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhalation, Systemic and Bronchoscopy in people with Healthy, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration of Salbutamol in the lung (time frame: change from baseline to 1 hour and 24,5 hours post dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019; AzTrials last refreshed its copy on 3 Nov 2026.