Bio samples and bio markers for development of the biosensor toolkit within the REMEDIA project

Not Applicable

• Conditions: Healthy volunteers

• Registration Number: DRKS00026925
• Lead Sponsor: Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-20
• Study Completion: 2022-01-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Able and willing to give written informed consent
- Study population: Healthy male and female subjects, aged 18 to 50 years (inclusive). Female subjects must not be pregnant or nursing. Women of child bearing potential must use a highly effective contraception method during the study
- Subjects must be able to produce adequate sputum (= 2× 105 total non-squamous cells)
- Body mass index between 18 and 32 kg/m2 (inclusively)
- Subject must be non-smoker with a history of less than 1 pack year and not having smoked in the past years
- Appropriate lung function with FEV1 = 80 % of predicted value

Exclusion Criteria

- History of allergic rhinitis in the past 5 years
- Acute infection or any upper respiratory tract infection four weeks prior to informed consent visit
- Administration of corticosteroids via any route (e.g. intranasal, inhaled, oral) 4 weeks prior to informed consent visit

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collecting induced sputum and exhaled breath condensate at screening visit, prior to ozone challenge and 3, 5, and 6 hours after start of ozone challenge.

Secondary Outcome Measures

Name	Time	Method
Collecting exhaled particles and exhaled volatile organic compounds, measuring exhaled nitric oxide, exhaled carbon monoxide and blood biomarkers