Biosensor and Environmental Sensor Development Within the REMEDIA Project

Prior treatment

• 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.
• Infections of the lower respiratory tract within 4 weeks prior to screening
• Infections of the upper respiratory tract within 2 weeks prior to screening
• Positive drug screen for methadone, cannabis, opiates, cocaine metabolites, amphetamines, barbiturates and benzodiazepines at visit 1
• 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.
• 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.
• Positive drug screen for methadone, cannabis, opiates, cocaine metabolites, amphetamines, barbiturates and benzodiazepines at visit 1.

Other illness

• 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)
• Clinically relevant allergy against airborne allergens (such as pollen).
• History of drug or alcohol abuse
• 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).
• Clinically relevant allergy against airborne allergens (such as pollen).
• History of drug or alcohol abuse.

Other

• Healthy subjects:
• 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.
• 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:
• 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.
• 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.

• 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.