E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seasonal allergic rhinitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039776 |
E.1.2 | Term | Seasonal allergic rhinitis |
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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 |
To assess both the acute and the prophylactic effect of 2 dosages of BNO-1355 in seasonal allergic rhinitis compared to placebo |
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E.2.2 | Secondary objectives of the trial |
Not explicitly listed. For secondary endpoints and safety endpoints, see study protocol. |
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E.2.3 | Trial contains a sub-study | No |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
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E.3 | Principal inclusion criteria |
1. Signed informed consent including data protection declaration
2. Male or female outsubjects aged ≥18 and ≤ 65 years
3. Minimum 2 years history of seasonal allergic rhinitis
4. Positive skin prick test to Dactylis glomerata within 12 months prior to or on visit 1
5. TNSS score of ≥ 6 at least once during the 2h-baseline ECC exposure
6. FEV1 ≥ 80 % pred (ESCS) at screening
7. BMI ≥18 and ≤ 35
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E.4 | Principal exclusion criteria |
1. Chronic and perennial allergic rhinitis 2. Upper or lower respiratory tract infection 4 weeks before visit 2. 3. Significant pulmonary disease other than allergic rhinitis or mild intermittent asthma managed by SABA alone 4. Immunisations or vaccinations within 4 weeks prior to inclusion 5. Anti-allergy immunotherapy (desensitizing with allergens) within the previous two years 6. History of chronic rhinosinusitis 7. History of polyposis nasi 8. Anatomical deviations of the nasal septum that significantly impair ventilation / airflow 9. Known hypersensitivity to study medication or excipients 10. Known diseases of hyperreactive immune activity or autoimmune response 11. Underlying diseases leading to significant immune deficiency 12. Treatment with systemic, topical, nasal or inhalative corticosteroids within the last 4 weeks prior to study inclusion 13. Treatment with oral H1-Antihistamines or cromoglycates within 72 hrs before study inclusions 14. Treatment with antiinflammatory analgesics, mucolytics / secretolytics, or alternative medicine preparations for treatment of common cold like symptoms or with immunomodulating properties within the last 7 days prior to study inclusion 15. Treatment with medication that might interfere with rescue medication for allergic shock (e.g. beta blocker, ACE blocker) 16. Subjects requiring immunosuppressive treatment for any condition at study entry 17. Severe diseases of liver or kidney 18. Severe somatopathic, neurological and / or psychiatric diseases 19. Malignant growth (actual, condition after carcinoma not longer than 5 years without relapse) 20. History of alcohol or drug abuse 21. Parallel participation in another study, participation in a study within less than 30 days prior to study entry, or previous participation in this same study 22. Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant, or presenting an unstable psychiatric history) 23. Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible impact of the study 24. Subjects in custody by juridical or official order 25. Subjects who have difficulties in understanding the language (German) in which the subject information is given
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E.5 End points |
E.5.1 | Primary end point(s) |
The mean of the Total Nasal Symptom Score (TNSS) triggered by allergen challenge for the interval of 2 - 4 hours afters start of the allergen challenge.
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | No |
E.8.1.6 | Cross over | Yes |
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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |