Evaluation of Broncho-Vaxom(R) ability to respond to the induction of inflammation through the inhalation of a bacterial component.Participants of the study will be assigned by chance to one of the treatment arms and Broncho-Vaxom(R) will be compared to a product with no treatment value (placebo). Neither the participants nor the study staff will know which subject receive Broncho-Vaxom(R) or the placebo.

• Conditions: healthy volunteersintended indication : Experimental induced bronchitis in healthy volunteers; MedDRA version: 14.1Level: LLTClassification code 10021832Term: Infection inducedSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10006451Term: BronchitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-000712-29-DE
• Lead Sponsor: OM Pharma SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-11
• Last Update Posted: 4 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified