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 |
| Secondary identifying numbers | BV2012/05 |
- 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
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
| Study design | Randomized double-blind placebo-controlled single center phase II trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 29/08/2012 |
| Completion date | 31/01/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
60590
Germany
Sponsor information
OM Pharma [Vifor Pharma] (Switzerland)
Industry
Industry
c/o Christian Terreaux
Rue du Bois du Lan 22
Meyrin/Geneva
CH-1217
Switzerland
| Website | http://www.viforpharma.com/en/ |
|---|---|
"ROR" |
https://ror.org/0185z7g17 |
Funders
Funder type
Industry
OM Pharma [Vifor Pharma] (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
