Bronchitis Respiratory Bronchitis, not specified as acute or chronic
Conditions
Interventions
Skin prick test, blood sampling, at visit 4, all subjects will inhale a single dose of 50ug Escherichia coli - Lipopolysaccharide via a medic aid nebulizer and an aerosol provocation system powered b
Sponsors
OM Pharma [Vifor Pharma] (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have been informed of the study procedures and medications and have given their written informed consent 2. Healthy male and female of any race 3. Aged 18 to 45 years
Exclusion criteria
Exclusion criteria: 1. Have received systemic or inhaled corticosteroids within 4 weeks before Visit 1 2. Have smoked on a regular basis within 2 years before Visit 1 or who have a smoking history > 10 pack years 3. An active lung disease (e.g. asthma, chronic bronchitis, COPD) 4. Have suffered from a respiratory tract infection within 4 weeks preceding the study period. 5. Predicted FEV1 below 80% at visit 1 6. Clinically significant uncontrolled systemic disease or a history of such disease (e.g. cancer, infection, hematological disease, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinology or gastrointestinal disease) within the previous 3 months 7. Clinically significant laboratory abnormalities at Visit 1 8. A platelet count less or equal to 130 x 10@9/L at Visit 1 9. A result for Methacholine-test below 0.1 mg at Visit 1 10. Skin prick test result >5mm and a corresponding history of allergic asthma 11. With a clinically significant abnormal finding detected on Electrocardiogram at visit 1 12. A history of food or drug related severe anaphylactoid or anaphylactic reaction(s) 13. Are pregnant or nursing mothers 14. Who are of child bearing potential and who are not protected by a reliable contraceptive method (oral, subcutaneous, mechanical, or surgical contraception). Any woman who becomes pregnant during the course of the study must be discontinued, any female who starts her menarche during the trial and is not, for whatever reason, protected by a medically approved contraception must be withdrawn from the trial 15. Known hypersensitivity to any ingredients of BV 16. Volunteers who are considered potentially unreliable and volunteers who may not reliably attend study drug visits 17. A history of drug or alcohol abuse 18. Are unable to perform spirometry and peak flow measurements or complete the subject's diary 19. Have participated in another clinical study within 3 months prior to Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline on total IgA level in saliva after 4 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The reduction of the inflammatory response after a LPS inhalation challenge 2. The reduction on one of the following LPS-induced responses: 2.1. Leukocytes, neutrophils, CRP, LPS-binding protein (LBP) levels in serum 2.2. Neutrophilic inflammation and inflammatory cytokines in induced sputum 2.3. Bronchoconstriction (FEV1 decrease) 2.4. Local symptoms: cough, chest tightness 2.5. Systemic effects like increase of body temperature, chills and headache | — |
Countries
Germany
Outcome results
None listed