Biosensor and Environmental Sensor Development Within the REMEDIA Project

Not Applicable

Completed

• Conditions: Healthy; Chronic Obstructive Pulmonary Disease
• Interventions: Other: Exposure to clean air; Other: Exposure to urban air

• Registration Number: NCT06035276
• Lead Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine

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.

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 Timeline

• Study Start: 2023-08-28
• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-13
• Primary Completion: 2024-04-19
• Status Verified: 2025-02
• Study Completion: 2025-04-01
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
COPD patients	Exposure to urban air	-
Healthy subjects	Exposure to clean air	-
COPD patients	Exposure to clean air	-
Healthy subjects	Exposure to urban air	-

Primary Outcome Measures

Name	Time	Method
Data collected by environmental sensor	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
Concentration of Biomarkers in exhaled breath condensate collected by biosensor	On day 1,3,5,8,10, and 12 of the study	Neutrophil Elastase

Trial Locations

Locations (1)

Fraunhofer ITEM; 🇩🇪 Hannover, Lower Saxony, Germany