Evaluation of Broncho-Vaxom(R) ability to respond to the induction of inflammation through the inhalation of a bacterial component

ISRCTN	ISRCTN25212012
DOI	https://doi.org/10.1186/ISRCTN25212012
Protocol serial number	BV2012/05
Sponsor	OM Pharma [Vifor Pharma] (Switzerland)
Funder	OM Pharma [Vifor Pharma] (Switzerland)

Submission date: 18/09/2012
Registration date: 24/10/2012
Last edited: 24/10/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Stefan Zielen
Scientific

Zentrum für Kinder- und Jugendmedizin
Allergologie, Pneumologie und Mukoviszidose
Klinikum der Johann Wolfgang Goethe-Universität
Theodor-Stern-Kai 7
Frankfurt/Main
60590
Germany

Study information

Primary study design	Interventional
Study design	Randomized double-blind placebo-controlled single center phase II trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Clinical and immune modifying capacity of Broncho-Vaxom tested by LPS challenge in healthy volunteers
Study objectives	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(s)	Ethics Committee of the State Medical Association Hesse, 27 August 2012, ref: FF61/2012
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	The change from baseline on total IgA level in saliva after 4 weeks of treatment
Key secondary outcome measure(s)	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
Completion date	31/01/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	29/08/2012
Date of final enrolment	31/01/2013

Locations

Countries of recruitment

Germany

Study participating centre

Zentrum für Kinder- und Jugendmedizin

Frankfurt/Main
60590
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes