Biosensor and Environmental Sensor Development Within the REMEDIA Project

NCT06035276 | Completed

• 1 other identifier: 23-01 REMEDIA-2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Obstructive Pulmonary Disease; Healthy

Outcome Measures

Primary Outcomes (14)

• Concentration of Biomarkers in exhaled breath condensate collected by biosensor

  3-Nitrotyrosin

  On day 1,3,5,8,10, and 12 of the study

• Concentration of Biomarkers in exhaled breath condensate collected by biosensor

  Hexanal

  On day 1,3,5,8,10, and 12 of the study

• Concentration of Biomarkers in exhaled breath condensate collected by biosensor

  Neutrophil Elastase

  On day 1,3,5,8,10, and 12 of the study

• Data collected by environmental sensor

  Concentration of CO

  Through study completion (study days 1-12)

• Data collected by environmental sensor

  Concentration of O3

  Through study completion (study days 1-12)

• Data collected by environmental sensor

  Concentration of SO2

  Through study completion (study days 1-12)

• Data collected by environmental sensor

  Concentration of NO2

  Through study completion (study days 1-12)

• Data collected by environmental sensor

  Concentration of VOC

  Through study completion (study days 1-12)

• Data collected by environmental sensor

  Concentration of PM10

  Through study completion (study days 1-12)

• Data collected by environmental sensor

  Concentration of PM2.5

  Through study completion (study days 1-12)

• Data collected by environmental sensor

  temperature

  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 %

  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

  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

  Through study completion (study days 1-12)

Study Arms (2)

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

Interventions

Exposure to clean air OTHER

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.

COPD patients; Healthy subjects

Exposure to urban air OTHER

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.

COPD patients; Healthy subjects

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects:
• Able and willing to give written informed consent.
• 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.
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead

Study Sites (1)

Fraunhofer ITEM

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (3)

• 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.

  PMID: 29750581 BACKGROUND

• 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.

  PMID: 29849481 BACKGROUND

• 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.

  PMID: 10051250 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 13, 2023
• Study Start: August 28, 2023
• Primary Completion: April 19, 2024
• Study Completion: April 1, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)