Healthy Clinical Trial
Official title:
Sample Collection for Biosensor Development Using Real-world Conditions With Exposure to "Urban" Versus "Clean" Air in Healthy Subjects and COPD Patients.
The aim of this proof-of-concept study is to obtain data that will contribute to the development of sensor devices (biosensor and environmental sensor) for patients with lung diseases (e.g. COPD). The study aims to validate our previous results from healthy subjects by joint testing of the biosensor and environmental device in a real-world setting. Healthy subjects and COPD subjects will be exposed to air of a traffic dense urban region ("urban" air) and to filtered indoor air ("clean" air) during activity and rest. Environmental and biomarker sensors will be used to measure several biomarkers and environmental conditions.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion criteria: Healthy subjects: 1. Able and willing to give written informed consent. 2. Healthy male and female subjects aged 40-70 years, inclusive. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see assessment schedule), and not breastfeeding. Of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is postmenopausal, with documented proof of hysterectomy or tubal ligation, without an alternative medical cause according to the Clinical Trial Facilitation Group (CTFG) document "Recommendations related to contraception and pregnancy testing in clinical trials"). Of childbearing potential and using a highly effective method of contraception according to the contraception requirements in section 7.2 from two weeks prior to visit 1 until the end of study participation. 3. Normal lung function with FEV1 predicted = 80% and FEV1/FVC=70%. 4. Body mass index of =18.6 and =30 kg/m2 5. Non-smoker or former smoker with <10 pack years who had stopped smoking (including e-cigarettes) for at least 12 months before Screening. COPD subjects: 1. Able and willing to give written informed consent. 2. Male and female subjects aged 40-70 years, inclusive. Women will be considered for inclusion if they are: Not pregnant, as confirmed by pregnancy test (see assessment schedule), and not breastfeeding. Of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is postmenopausal, with documented proof of hysterectomy or tubal ligation, without an alternative medical cause according to the Clinical Trial Facilitation Group (CTFG) document "Recommendations related to contraception and pregnancy testing in clinical trials"). Of childbearing potential and using a highly effective method of contraception according to the contraception requirements in section 7.2 from two weeks prior to visit 1 until the end of study participation. 3. Clinical diagnosis of COPD stage 1 to 2 (GOLD classification) 4. FEV1/FVC <70% post-bronchodilator at visit 1 5. FEV1 =50% of the predicted normal value post-bronchodilator at visit 1 6. FEV1 =1.5L pre-bronchodilator 7. Ex-smokers for at least 12 months with a history of at least 10 pack years. 8. Body mass index of = 18.6 and =30 kg/m2. Exclusion criteria: Healthy subjects: 1. Past or present disease, which as judged by the investigator, may affect the outcome of the study or put the subject at risk because of participation in the study. These diseases include, but are not limited to, coagulation disorders, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological 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) 2. Regular intake of any prescribed or over the counter medication. Exceptions include paracetamol for short term pain relief, oral contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements. 3. Clinically relevant allergy against airborne allergens (such as pollen). 4. Infections of the lower respiratory tract within 4 weeks prior to screening 5. Infections of the upper respiratory tract within 2 weeks prior to screening 6. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, 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. 7. Positive drug screen for methadone, cannabis, opiates, cocaine metabolites, amphetamines, barbiturates and benzodiazepines at visit 1 8. History of drug or alcohol abuse 9. Risk of non-compliance with study procedures 10. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study COPD subjects: 1. Past or present disease other than COPD, which as judged by the investigator, may affect the outcome of the study or put the subject at risk because of participation in the study. These diseases include, but are not limited to, coagulation disorders cardiovascular disease, malignancy, hepatic disease, renal disease, haematological 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). 2. Regular intake of any prescribed or over the counter medication, which as judged by the investigator, may affect the outcome of the study or put the subject at risk because of participation in the study. Explicitly not allowed is treatment with GCS, NSAIDs or any other anti-inflammatory medication. Explicitly allowed is treatment with SABA/LABA/LAMA, paracetamol for pain relief, antihypertensives, lipid-lowering medications, antidiabetics, oral contraceptive medication, hormonal replacement therapy, dietary and vitamin supplements. 3. Clinically relevant allergy against airborne allergens (such as pollen). 4. Infections of the lower respiratory tract within 4 weeks prior to screening. 5. Infections of the upper respiratory tract within 2 weeks prior to screening 6. Exacerbation of COPD (treatment with oral or parenteral antibiotics and/or oral or parenteral GCS and/or hospitalization related to COPD) within 60 days before visit 1. 7. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, 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. 8. Positive drug screen for methadone, cannabis, opiates, cocaine metabolites, amphetamines, barbiturates and benzodiazepines at visit 1. 9. History of drug or alcohol abuse. 10. Risk of non-compliance with study procedures. 11. Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study. |
Country | Name | City | State |
---|---|---|---|
Germany | Fraunhofer ITEM | Hannover | Lower Saxony |
Lead Sponsor | Collaborator |
---|---|
Fraunhofer-Institute of Toxicology and Experimental Medicine |
Germany,
De Rose V, Molloy K, Gohy S, Pilette C, Greene CM. Airway Epithelium Dysfunction in Cystic Fibrosis and COPD. Mediators Inflamm. 2018 Apr 8;2018:1309746. doi: 10.1155/2018/1309746. eCollection 2018. — View Citation
Fernandez Fernandez E, De Santi C, De Rose V, Greene CM. CFTR dysfunction in cystic fibrosis and chronic obstructive pulmonary disease. Expert Rev Respir Med. 2018 Jun;12(6):483-492. doi: 10.1080/17476348.2018.1475235. Epub 2018 May 23. — View Citation
Holz O, Jorres RA, Timm P, Mucke M, Richter K, Koschyk S, Magnussen H. Ozone-induced airway inflammatory changes differ between individuals and are reproducible. Am J Respir Crit Care Med. 1999 Mar;159(3):776-84. doi: 10.1164/ajrccm.159.3.9806098. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of Biomarkers in exhaled breath condensate collected by biosensor | 3-Nitrotyrosin | On day 1,3,5,8,10, and 12 of the study | |
Primary | Concentration of Biomarkers in exhaled breath condensate collected by biosensor | Hexanal | On day 1,3,5,8,10, and 12 of the study | |
Primary | Concentration of Biomarkers in exhaled breath condensate collected by biosensor | Neutrophil Elastase | On day 1,3,5,8,10, and 12 of the study | |
Primary | Data collected by environmental sensor | Concentration of CO | Through study completion (study days 1-12) | |
Primary | Data collected by environmental sensor | Concentration of O3 | Through study completion (study days 1-12) | |
Primary | Data collected by environmental sensor | Concentration of SO2 | Through study completion (study days 1-12) | |
Primary | Data collected by environmental sensor | Concentration of NO2 | Through study completion (study days 1-12) | |
Primary | Data collected by environmental sensor | Concentration of VOC | Through study completion (study days 1-12) | |
Primary | Data collected by environmental sensor | Concentration of PM10 | Through study completion (study days 1-12) | |
Primary | Data collected by environmental sensor | Concentration of PM2.5 | Through study completion (study days 1-12) | |
Primary | Data collected by environmental sensor | temperature | Through study completion (study days 1-12) | |
Primary | Data collected by environmental sensor | Humidity of the subject's ambient air within a range of 0 % to 100 % and with a resolution of 1 % | Through study completion (study days 1-12) | |
Primary | Data collected by environmental sensor | Light level of the subject's environment within a range of 350 nm to 1100 nm | Through study completion (study days 1-12) | |
Primary | Data collected by environmental sensor | Sound level of the subject's environment within a range of 20 Hz to 10 kHz and with a resolution of 1 Pa / 1 kHz | Through study completion (study days 1-12) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |