Condition category
Respiratory
Date applied
18/09/2012
Date assigned
24/10/2012
Last edited
24/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stefan Zielen

ORCID ID

Contact details

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

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

http://www.viforpharma.com/en/

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

Publication citations

Additional files

Editorial Notes