Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BV2012/05
Study information
Scientific title
Clinical and immune modifying capacity of Broncho-Vaxom tested by LPS challenge in healthy volunteers
Acronym
Study hypothesis
To demonstrate that healthy volunteers treated with Broncho-Vaxom (BV) will develop total antibody levels (i.e. total secretory IgA in saliva) after 4 weeks of treatment compared to placebo.
Ethics approval
Ethics Committee of the State Medical Association Hesse, 27 August 2012, ref: FF61/2012
Study design
Randomized double-blind placebo-controlled single center phase II trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Bronchitis
Intervention
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 by compressed air, ECG and spirometry
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measures
The change from baseline on total IgA level in saliva after 4 weeks of treatment
Secondary outcome measures
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
Overall trial start date
29/08/2012
Overall trial end date
31/01/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant 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
Recruitment start date
29/08/2012
Recruitment end date
31/01/2013
Locations
Countries of recruitment
Germany
Trial participating centre
Zentrum für Kinder- und Jugendmedizin
Frankfurt/Main
60590
Germany
Sponsor information
Organisation
OM Pharma [Vifor Pharma] (Switzerland)
Sponsor details
c/o Christian Terreaux
Rue du Bois du Lan 22
Meyrin/Geneva
CH-1217
Switzerland
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
OM Pharma [Vifor Pharma] (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary