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

Completed

• Conditions: Bronchitis; Respiratory; Bronchitis, not specified as acute or chronic

• Registration Number: ISRCTN25212012
• Lead Sponsor: OM Pharma [Vifor Pharma] (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-24
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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approved contraception must be withdrawn from the trial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

Study & Design

• Study Type: Interventional
• Study Design: Not specified