healthy volunteers intended indication : Experimental induced bronchitis in healthy volunteers MedDRA version: 14.1 Level: LLT Classification code 10021832 Term: Infection induced System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10006451 Term: Bronchitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Broncho-Vaxom Erwachsene
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
OM Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Volunteers to be included in this study are those : - who have been informed of the study procedures and have given their written informed consent. - Healthy male and female of any race - aged 18 to 45 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Volunteers to be excluded from this study are those : - who have received systemic or inhaled corticosteroids within 4 weeks of Visit 1 - who have smoked on a regular basis within 2 years of Visit 1 or who have a smoking history > 10 pack years - with an active lung disease (e.g. asthma, chronic bronchitis, COPD) - who have suffered from a respiratory tract infection within the 4 weeks preceding the study period - with predicted FEV1 below 80% at visit 1 - with 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 - with clinically significant laboratory abnormalities at Visit 1 - with a platelet count = 130 x 109/L at visit 1 - with Methacholine-test below 0.1mg at V1 - with a clinically significant abnormal finding detected on ECG at visit 1 - with a skin prick test result >5mm and a corresponding history of allergic asthma - with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint will be the change from baseline on secretory IgA level in saliva after 4 weeks of study treatment;Secondary Objective: The secondary objective will be the reduction of the inflammatory response after LPS challenge: 1. Leukocytes, Neutrophils, C-Reactive protein, Lipopolysaccharide-binding protein levels in serum 2. Neutrophilic inflammation in induced sputum 3. Bronchoconstriction (FEV1 decrease) 4. Local symptoms like chest tightness cough 5. Systemic effects like increase of body temperature, chills and headache ;Primary end point(s): Change from baseline of scretory IgA level in saliva after 4 weeks of treatment with Broncho-Vaxom®;Timepoint(s) of evaluation of this end point: The end point will be evaluated after the last patient out | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Reduction of the inflammatory response after a LPS inhalation challenge. The secondary endpoints supporting this objective will be the reduction on one of the following LPS-induced responses: 1. Leukocytes, neutrophils, CRP, LPS-binding protein (LBP) levels in serum 2. Neutrophilic inflammation and inflammatory cytokines in induced sputum 3. Bronchoconstriction (FEV1 decrease) 4. Local symptoms: cough, chest tightness 5. Systemic effects like increase of body temperature, chills and headache.;Timepoint(s) of evaluation of this end point: The end point will be evaluated after the last patient out | — |
Countries
Germany
Contacts
Public ContactClinical Project Coordinator
OM Pharma SA
Outcome results
None listed