Chronic Obstructive Pulmonary DiseaseNCT06035276
Biosensor and Environmental Sensor Development Within the REMEDIA Project
A study testing Exposure to clean air and Exposure to urban air in people with Chronic Obstructive Pulmonary Disease and Healthy, run by Fraunhofer-Institute of Toxicology and Experimental Medicine at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Healthy
- What is being tested?
- Exposure to clean air and Exposure to urban air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 28 Aug 2023to 1 Apr 2025
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 21Show fewer
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read 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 pulmonary disease (COPD) and cystic fibrosis (CF). While COPD is considered to be mainly related to the external exposome (smoking, ambient particulate matter, household air pollution, occupational particulate matter, ozone and second-hand smoke) CF is the consequence of a genetic defect in the CFTR gene, which gives an essential role to factors outside of the exposome. However, COPD and CF share common characteristics such as high phenotypic variability of unknown origin, and similar progressive loss of lung function with small bronchi alterations. Given this high phenotypic variability it is clear that the overall picture must be supplemented by considering additional components of the exposome. The REMEDIA project investigates the specific exposome associated with particular COPD or CF phenotypes.
Objective of work package 3 within the REMEDIA project is the development of a mobile environmental sensor toolbox that is capable to assess the external exposome (temperature, humidity, particulate matter (PM), volatile organic compounds (VOC), nitrogen dioxide (NO2), ozone (O3), carbon-monoxide (CO), and sulfur dioxide (SO2)) and a mobile biosensor unit that can measure inflammatory biomarkers in exhaled breath. Currently specific sensors for the analysis of hexanal, nitrotyrosine and neutrophils elastase are included into the sensor tool kit. Other relevant molecules are evaluated and selected in other work packages and could be included into the tool kit.
Our previous experimental exposure study focused on the major environmental air pollutant ozone and was supposed to test the biosensor unit under close to "real life conditions". Ozone is known to cause a temporary neutrophilic airway inflammation, which is also typical for patients with COPD and CF.
This proof-of-concept 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. The biosensor will measure the following biomarker: 3-Nitrotyrosin, Hexanal and Neutrophil Elastase. The environmental sensor will measure the following parameters: CO, O3, SO2, NO2, VOC, PM10, PM2.5, temperature, humidity, light and sound level. The collected data will be evaluated in terms of population and exposure.
- Conditions
- Chronic Obstructive Pulmonary Disease, Healthy
- Being tested
- Exposure to clean air, Exposure to urban air
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure to clean airOther
Subjects will be exposed to filtered indoor air ("clean" air) for 4 hours in the Fraunhofer Environmental Exposure Chamber. The chamber can accommodate up to 18 subjects, is ventilated by HEPA-filtered and conditioned air, ensuring a constant humidity (40 ± 10%), temperature (22 ± 2°C), and airflow (1500 ± 100 m3/hr). During exposure they will perform an intermittent bicycle ergometer activity at 50 W for 10 minutes alternating with 20 minutes rest.
Exposure to urban airOther
Subjects will be brought to a traffic dense urban region ("urban air") with high traffic density and increased levels of particulate matter and vehicle emissions. Subjects will stay in this area for 4 hours. During exposure, all subjects will walk together with study staff. Rest periods are only allowed outside. Intervals of activity and rest will be similar to the "clean air" regimen.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Other | Not described Receives: Other: Exposure to clean air; Other: Exposure to urban air |
| COPD patients | Other | Not described Receives: Other: Exposure to clean air; Other: Exposure to urban air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Biomarkers in exhaled breath condensate collected by biosensor
3-Nitrotyrosin
Measured: On day 1,3,5,8,10, and 12 of the study
Concentration of Biomarkers in exhaled breath condensate collected by biosensor
Hexanal
Measured: On day 1,3,5,8,10, and 12 of the study
Concentration of Biomarkers in exhaled breath condensate collected by biosensor
Neutrophil Elastase
Measured: On day 1,3,5,8,10, and 12 of the study
Data collected by environmental sensor
Concentration of CO
Measured: Through study completion (study days 1-12)
Data collected by environmental sensor
Concentration of O3
Measured: Through study completion (study days 1-12)
Data collected by environmental sensor
Concentration of SO2
Measured: Through study completion (study days 1-12)
Data collected by environmental sensor
Concentration of NO2
Measured: Through study completion (study days 1-12)
Data collected by environmental sensor
Concentration of VOC
Measured: Through study completion (study days 1-12)
Data collected by environmental sensor
Concentration of PM10
Measured: Through study completion (study days 1-12)
Data collected by environmental sensor
Concentration of PM2.5
Measured: Through study completion (study days 1-12)
Data collected by environmental sensor
temperature
Measured: Through study completion (study days 1-12)
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 %
Measured: Through study completion (study days 1-12)
Data collected by environmental sensor
Light level of the subject's environment within a range of 350 nm to 1100 nm
Measured: Through study completion (study days 1-12)
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
Measured: Through study completion (study days 1-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start28 Aug 2023
- Primary completion19 Apr 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This study is a single-center research project with a 2-period, sequential, cross-over ("clean" vs. versus "urban" air) design, which supports the development of the REMEDIA sensor toolkit with clinically relevant data and bio samples. The approach is exploratory, blinding or randomization are not applicable. Two populations will participate: healthy subjects and COPD subjects with GOLD stage 1 to 2.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035276
- Sponsor's protocol ID
- 23-01 REMEDIA-2
- Status last verified
- Feb 2025
- First submitted
- 28 Aug 2023
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29750581De 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.
PubMed 29849481Holz 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.
PubMed 10051250
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sample Collection for Biosensor Development Using Real-world Conditions With Exposure to "Urban" Versus "Clean" Air in Healthy Subjects and COPD Patients.
- ClinicalTrials.gov ID
- NCT06035276
- Acronym / sponsor ID
- 23-01 REMEDIA-2
- Conditions
- Chronic Obstructive Pulmonary Disease, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fraunhofer-Institute of Toxicology and Experimental MedicineUniversity, hospital or other
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 13 Sep 2023 (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 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.
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 pulmonary disease (COPD) and cystic fibrosis (CF). While COPD is considered to be mainly related to the external exposome (smoking, ambient particulate matter, household air pollution, occupational particulate matter, ozone and second-hand smoke) CF is the consequence of a genetic defect in the CFTR gene, which gives an essential role to factors outside of the exposome. However, COPD and CF share common characteristics such as high phenotypic variability of unknown origin, and similar progressive loss of lung function with small bronchi alterations. Given this high phenotypic variability it is clear that the overall picture must be supplemented by considering additional components of the exposome. The REMEDIA project investigates the specific exposome associated with particular COPD or CF phenotypes.
Objective of work package 3 within the REMEDIA project is the development of a mobile environmental sensor toolbox that is capable to assess the external exposome (temperature, humidity, particulate matter (PM), volatile organic compounds (VOC), nitrogen dioxide (NO2), ozone (O3), carbon-monoxide (CO), and sulfur dioxide (SO2)) and a mobile biosensor unit that can measure inflammatory biomarkers in exhaled breath. Currently specific sensors for the analysis of hexanal, nitrotyrosine and neutrophils elastase are included into the sensor tool kit. Other relevant molecules are evaluated and selected in other work packages and could be included into the tool kit.
Our previous experimental exposure study focused on the major environmental air pollutant ozone and was supposed to test the biosensor unit under close to "real life conditions". Ozone is known to cause a temporary neutrophilic airway inflammation, which is also typical for patients with COPD and CF.
This proof-of-concept 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. The biosensor will measure the following biomarker: 3-Nitrotyrosin, Hexanal and Neutrophil Elastase. The environmental sensor will measure the following parameters: CO, O3, SO2, NO2, VOC, PM10, PM2.5, temperature, humidity, light and sound level. The collected data will be evaluated in terms of population and exposure.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a single-center research project with a 2-period, sequential, cross-over ("clean" vs. versus "urban" air) design, which supports the development of the REMEDIA sensor toolkit with clinically relevant data and bio samples. The approach is exploratory, blinding or randomization are not applicable. Two populations will participate: healthy subjects and COPD subjects with GOLD stage 1 to 2.
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Other | Other: Exposure to clean air, Other: Exposure to urban air |
| COPD patients | Other | Other: Exposure to clean air, Other: Exposure to urban air |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
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 |
|---|---|---|
| Exposure to clean airSubjects will be exposed to filtered indoor air ("clean" air) for 4 hours in the Fraunhofer Environmental Exposure Chamber. The chamber can accommodate up to 18 subjects, is ventilated by HEPA-filtered and conditioned air, ensuring a constant humidity (40 ± 10%), temperature (22 ± 2°C), and airflow (1500 ± 100 m3/hr). During exposure they will perform an intermittent bicycle ergometer activity at 50 W for 10 minutes alternating with 20 minutes rest. | Other | COPD patients, Healthy subjects |
| Exposure to urban airSubjects will be brought to a traffic dense urban region ("urban air") with high traffic density and increased levels of particulate matter and vehicle emissions. Subjects will stay in this area for 4 hours. During exposure, all subjects will walk together with study staff. Rest periods are only allowed outside. Intervals of activity and rest will be similar to the "clean air" regimen. | Other | COPD patients, Healthy subjects |
Primary outcome
Concentration of Biomarkers in exhaled breath condensate collected by biosensor
Time frame: On day 1,3,5,8,10, and 12 of the study
3-Nitrotyrosin
Concentration of Biomarkers in exhaled breath condensate collected by biosensor
Time frame: On day 1,3,5,8,10, and 12 of the study
Hexanal
Concentration of Biomarkers in exhaled breath condensate collected by biosensor
Time frame: On day 1,3,5,8,10, and 12 of the study
Neutrophil Elastase
Data collected by environmental sensor
Time frame: Through study completion (study days 1-12)
Concentration of CO
Data collected by environmental sensor
Time frame: Through study completion (study days 1-12)
Concentration of O3
Data collected by environmental sensor
Time frame: Through study completion (study days 1-12)
Concentration of SO2
Data collected by environmental sensor
Time frame: Through study completion (study days 1-12)
Concentration of NO2
Data collected by environmental sensor
Time frame: Through study completion (study days 1-12)
Concentration of VOC
Data collected by environmental sensor
Time frame: Through study completion (study days 1-12)
Concentration of PM10
Data collected by environmental sensor
Time frame: Through study completion (study days 1-12)
Concentration of PM2.5
Data collected by environmental sensor
Time frame: Through study completion (study days 1-12)
temperature
Data collected by environmental sensor
Time frame: Through study completion (study days 1-12)
Humidity of the subject's ambient air within a range of 0 % to 100 % and with a resolution of 1 %
Data collected by environmental sensor
Time frame: Through study completion (study days 1-12)
Light level of the subject's environment within a range of 350 nm to 1100 nm
Data collected by environmental sensor
Time frame: Through study completion (study days 1-12)
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
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 26 Jun 2025.
- Background: PubMed 29750581Fernandez 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.
- Background: PubMed 29849481De 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.
- Background: PubMed 10051250Holz 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure to clean air and Exposure to urban air in people with Chronic Obstructive Pulmonary Disease and 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 21 inclusion and 23 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 26 Jun 2025. 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?
Concentration of Biomarkers in exhaled breath condensate collected by biosensor (time frame: On day 1,3,5,8,10, and 12 of the study). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035276, which also lists 3 linked publications.
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 26 Jun 2025.