E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
healthy volunteers
intended indication : Experimental induced bronchitis in healthy volunteers |
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E.1.1.1 | Medical condition in easily understood language |
healthy volunteers
intended indication : Experimental induced bronchitis in healthy volunteers |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021832 |
E.1.2 | Term | Infection induced |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006451 |
E.1.2 | Term | Bronchitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary endpoint will be the change from baseline on secretory IgA level in saliva after 4 weeks of study treatment |
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E.2.2 | Secondary objectives of the trial |
The secondary objective will be the reduction of the inflammatory response after LPS challenge:
1. Leukocytes, Neutrophils, C-Reactive protein, Lipopolysaccharide-binding protein levels in serum
2. Neutrophilic inflammation in induced sputum
3. Bronchoconstriction (FEV1 decrease)
4. Local symptoms like chest tightness cough
5. Systemic effects like increase of body temperature, chills and headache
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Volunteers to be included in this study are those :
- who have been informed of the study procedures and have given their written informed consent.
- Healthy male and female of any race
- aged 18 to 45 years
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E.4 | Principal exclusion criteria |
Volunteers to be excluded from this study are those :
- who have received systemic or inhaled corticosteroids within 4 weeks of Visit 1
- who have smoked on a regular basis within 2 years of Visit 1 or who have a smoking history > 10 pack years
- with an active lung disease (e.g. asthma, chronic bronchitis, COPD)
- who have suffered from a respiratory tract infection within the 4 weeks preceding the study period
- with predicted FEV1 below 80% at visit 1
- with 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
- with clinically significant laboratory abnormalities at Visit 1
- with a platelet count ≤ 130 x 109/L at visit 1
- with Methacholine-test below 0.1mg at V1
- with a clinically significant abnormal finding detected on ECG
at visit 1
- with a skin prick test result >5mm and a corresponding history of allergic asthma
- with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline of scretory IgA level in saliva after 4 weeks of treatment with Broncho-Vaxom® |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The end point will be evaluated after the last patient out |
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E.5.2 | Secondary end point(s) |
Reduction of the inflammatory response after a LPS inhalation challenge. The secondary endpoints supporting this objective will be the reduction on one of the following LPS-induced responses:
1. Leukocytes, neutrophils, CRP, LPS-binding protein (LBP) levels in serum
2. Neutrophilic inflammation and inflammatory cytokines in induced sputum
3. Bronchoconstriction (FEV1 decrease)
4. Local symptoms: cough, chest tightness
5. Systemic effects like increase of body temperature, chills and headache. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The end point will be evaluated after the last patient out |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
2 doses of Broncho-Vaxom are tested in this trial, 7mg/day and 21mg/day |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |