E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052106 |
E.1.2 | Term | Rhinosinusitis |
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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 evaluate the efficacy and safety of Broncho-Vaxom in adults suffering from chronic rhinosinusitis. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy and safety of Broncho-Vaxom concerning the time until patient is "asymptomatic" and consumption of rescue medication (antibiotics, analgetics and topical corticosteroids) in comparison to Placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- patients of either sex aged 18 - 75 - patients must experience a facial pain especially unilaterally; and at least one of the two following symptoms (> 50 % of days in the last 3 months): more than 12 consecutive weeks of symptomatic nasal obstruction and/or more than 12 weeks of symptomatic nasal discharge - an otorhinolaryngologist (ENT) evaluation and diagnosis of chronic inflammatory rhinosinusitis (hyperplastic mucosa, nasal polyps) and either endoscopic signs and/or CT -patients having given their written informed consent
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E.4 | Principal exclusion criteria |
- sinus surgery within the last 3 months - acute illness within the last 2 weeks requiring antibiotics - immunosuppression - sinister signs requiring intermediate intervention - serious concomitant disease, which might interfere with or modify the outcome - patients with acute bacterial rhinosinusitis as increase of symptoms after 5 days or persistent symptoms after 10 days with less than 12 weeks duration - patients under immunosuppressive or immunostimulating therapy within 1 month prior to study start - patients under systemic corticosteroid therapy within 1 month prior to study start with a regular oral corticosteroids > 10 mg of prednisolone more than 2 weeks - patients with a known allergy or previous intolerance or known hypersensitivity to the trial drug |
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparisons between the two groups of severity of rhinosinusitis (SNOT-20) during the trial (AUC). |
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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 | 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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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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 | 19 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 19 |