Healthy volunteers
Conditions
Interventions
Group 1: Single ozone challenge: 3-hour stay in ozone challenge chamber at a concentration of 250 ppb. Alternating 15 minutes bicycle exercise to enhance ozone inhalation and 15 minutes rest. After oz
Sponsors
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Collecting exhaled particles and exhaled volatile organic compounds, measuring exhaled nitric oxide, exhaled carbon monoxide and blood biomarkers | — |
Countries
Germany
Contacts
Public ContactStudienzentrale
Fraunhofer-Institut für Toxikologie und Experimentelle Medizin ITEM
Outcome results
None listed