E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Due to the worldwide increasing prevalence of allergic rhinoconjunctivitis (AR), new therapeutical strategies are needed. The symptomatic treatment with topical and systemic antihistamines and corticosteroids are often insufficient. E. coli Nissle 1917 (EcN) has immunmodulatory capacities and reveals less side effects. EcN has no sedative properties and exhibits no hepatotoxic and nephrotoxic qualities. Thus, EcN represents a new relevant therapeutical agent. |
|
MedDRA Classification |
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 anti-allergic immunmodulatory effect of EcN on the immune system and the clinical symptoms of patients with seasonal AR to grass pollen will be assessed in an exploratory trial in comparison to placebo. The primary endpoint is the symptom-medication score (SMS) in the grass pollen season. |
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age between 18 and 65 years (women and men) Clinical relevat grass pollen allergy with required treatment of the rhinoconjunctivitis symptoms since at least 2 years Positive skin prick test (SPT) to grass pollen extract Positive specific IgE towards grass pollen (at least CAP class 2) Written inform consent
|
|
E.4 | Principal exclusion criteria |
Perennial rhinoconjunctivitis Chronic diarrhoe and other existing severe gastrointestinale diseases Asthma bronchiale (Gina II - IV) Use of Mutaflor® 12 weeks before the start of the trial Use of antibiotics towards gram negative bacteria 4 weeks before the start of the trial Specific immunotherapy to grass pollen 6 months before the start of the trial Current specific immunotherapy to any allergen Female patients: pregnancy and lactation period Severe cardiovascular diseases and metabolic disorders, autoimmune diseases or other systemic inflammatory disorders
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is to show the anti-allergic immunmodulatory effect of EcN determined by the symptom-medication score (SMS) in the grass pollen season in an exploratory trial in comparison to placebo. The SMS will be calculated by the daily sum of symptoms and the use of anti-allergic medication documented in patient diaries during grass pollen season. Documentation period of patient diaries covers 6 month per year. The exact period of analysis the SMS as area under the curve (AUC) will be defined on the basis of the real pollen counts occurred in the study year. The exact period of analysis the AUC of SMS will be a period of 45 days (14 days before and 31 days after the peak of grass pollen count.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
antiallergic immunmodulatory effect |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
|
The trial ends with the last visit (follow-up) of the last patient. The estimated date is the 9th of October 2009 (see protocoll chapter 4.4). |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |