E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute sinusitis or exacerbation of subacute or chronic sinusitis. |
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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 | 10040753 |
E.1.2 | Term | Sinusitis |
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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 objective of the study i sto demonstrate, in the studied cases, a percentage of remission of the sinusitis symptoms linked to the presence of mucus in the paranasal sinuses superior in the group treated with SINUclean DM, in comparison with the group treated with saline, or not treated with co-adjuvant treatment. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of the study is the time to remission of the symptoms of sinusitis, following the co-adjuvant treatment, specifically for those symptoms connected to the presence of mucus in the para-nasal sinuses: facial pain, nasal anterior and posterior dripping, nasal congestion, pain caused by manual pression in the zones interested by facial pain. Other objectives are the percentage and the time of the clinical healing of the acute episode of sinusitis, following association of the co-adjuvant treatment to the antibiotic therapy. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
8.Male, females 9.Age > 18 years. 10.Clinica diagnosis of acute sinusitis, or of exacerbation of subacute or chronic sinusitis, confirmed radiologically with a CTA scan image 11.Presence of mucus in the paranasal sinuses 12.Facial pain and congestion of the mucosa of paranasal sinuses since at least three days |
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E.4 | Principal exclusion criteria |
Clinical conditions (systemic pathologies, or other) that can interfere with the assessment of the safety and efficacy of the experimental product like for example: - viral or allergic rhinitis, with active secretive symptoms - presence of visible nasal polyps - diagnosis of immobile cilia syndromes - diseases causing immunodeficiencies - cystic fibrosis - immunocompromissione - renal block - dialysis - other pathologies of other apparatus that, in the opinion of the investigator, are interfering. Necessity of a supplemental antibiotic therapy, due to other pathologies, besides that for the treatment of sinusitis. Smoke during the period of the study History of intolerance or allergy to the components of SINUclean DM Medical or surgery intervention that can jeopardize the complete effectuation of the experimentation, in the four weeks preceding the signature of the informed consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study i sto demonstrate, in the studied cases, a percentage of remission of the sinusitis symptoms linked to the presence of mucus in the paranasal sinuses superior in the group treated with SINUclean DM, in comparison with the group treated with saline, or not treated with co-adjuvant treatment. |
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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 | 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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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.8.5 | 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 | Information not present in EudraCT |
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 | |
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 |