Status:
COMPLETED
Biosensor and Environmental Sensor Development Within the REMEDIA Project
Lead Sponsor:
Fraunhofer-Institute of Toxicology and Experimental Medicine
Conditions:
Chronic Obstructive Pulmonary Disease
Healthy
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
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...
Detailed Description
The EU-sponsored REMEDIA project (Impact of exposome on the course of lung diseases, Grant agreement ID 874753) contributes to the understanding of the influence of the exposome on chronic obstructive...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy subjects:
- Able and willing to give written informed consent.
- 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.
- Normal lung function with FEV1 predicted ≥ 80% and FEV1/FVC≥70%.
- Body mass index of ≥18.6 and ≤30 kg/m2
- 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:
- Able and willing to give written informed consent.
- 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.
- Clinical diagnosis of COPD stage 1 to 2 (GOLD classification)
- FEV1/FVC \<70% post-bronchodilator at visit 1
- FEV1 ≥50% of the predicted normal value post-bronchodilator at visit 1
- FEV1 ≥1.5L pre-bronchodilator
- Ex-smokers for at least 12 months with a history of at least 10 pack years.
- Body mass index of ≥ 18.6 and ≤30 kg/m2.
- Exclusion criteria:
- Healthy subjects:
- 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)
- 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.
- Clinically relevant allergy against airborne allergens (such as pollen).
- Infections of the lower respiratory tract within 4 weeks prior to screening
- Infections of the upper respiratory tract within 2 weeks prior to screening
- 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.
- Positive drug screen for methadone, cannabis, opiates, cocaine metabolites, amphetamines, barbiturates and benzodiazepines at visit 1
- 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
- COPD subjects:
- 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).
- 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.
- Clinically relevant allergy against airborne allergens (such as pollen).
- Infections of the lower respiratory tract within 4 weeks prior to screening.
- Infections of the upper respiratory tract within 2 weeks prior to screening
- 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.
- 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.
- Positive drug screen for methadone, cannabis, opiates, cocaine metabolites, amphetamines, barbiturates and benzodiazepines at visit 1.
- 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.
Exclusion
Key Trial Info
Start Date :
August 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06035276
Start Date
August 28 2023
End Date
April 1 2025
Last Update
June 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fraunhofer ITEM
Hanover, Lower Saxony, Germany, 30625