E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with acute recurrent rhinosinusitis(intercritical stages) |
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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 | 10001076 |
E.1.2 | Term | Acute 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 main objective of the study is to evaluate the effectiveness of therapy set in resolving the problems arising from rhinosinusal impaired ventilation and transport mucuciliary level structures rhinosinusal, assess the variability of motility and ultimately the production of catarrhal secretion before and after treatment with topical aerosolic therapy. It will the primary variable proportion of patients with improvement in symptoms (reduction greater than or equal to 70%), evaluated after 5 ± 2 days after the end of therapy |
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E.2.2 | Secondary objectives of the trial |
- Evaluate the proportion of patients with improvement in symptoms (reduc-tion greater than or equal to 70%) at follow-up visits (3 and 6 months after the completion of therapy) - Evaluate the COM and RSE sinusitis Precamere (COM = osteomeatal complex; RSE = withdrawal ethmoid-sphenoidal) at the end of therapy and at FU visits compared with baseline -Evaluate the changes of cellularity nasal before and after therapy -Evaluate the proportion of patients with improvement in the clearance mucusciliary after 5 ± 2 days after the end of therapy -Evaluate, for patients suffering from rhinitis applicants, the proportion of patients with relapse during the follow-up period -Evaluate the time between the end of treatment and recurrence of symptoms -Evaluate the number of exacerbations highlighted in the ob-servation period (FU) -Evaluate the ciliary motility in FU period -Evaluate the acceptability of treatment by the patient -Evaluate the need for a second prescription during FU |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
They will be included in the study patients males and females, with ages over 18 years, suffering from acute rhinosinusitis applicant (during interchronic). For rhinosinusitis will apply the classification of Lanza and Kennedy, which is based on the time evolution and manifestation of the disease and divided into the following categories rhinitis:-Rhinosinusitis acute: new infection, which lasts a maximum of 4 weeks-Rhinosinusitis acute applicant : presence of 4 or more attacks of acute rhinosinusitis during the year. For enrollment in the study, patients must be in the run-intercritica Rinosinusite subacute: infection with a duration of 4 a12 weeks. The study provides an assessment of patients with acute rhinosinusitis applicant, characterized by the appearance of 4 or more episodes during the year, during intercritical. It will be taken into consideration rhinosinusitis patients with acute, subacute or chronic riacute because these groups of patients there is the indication for antibiotic treatment in acute forms or a surgical treatment for other forms, correct anatomical defects at present structures rhinosinusal that cause respiratory functional deficits. Since the nature of inflammatory disease, bacterial aetiology should be excluded from post microbiological findings. Pending the outcome of laboratory, the decision to include the patient is also responsible for the responsibility of the individual clinical Experimenter. Any positivita is the result of microbiological tests will be deemed as breach of protocol. |
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E.4 | Principal exclusion criteria |
- Hypersensibility to study drug or any of the ingredients - active pulmonary tuberculosis or quiescent-peptic ulcer-Serious kidney or liver disorders-bronchial asthma (as primitive condition / Main) - Cardiovascular Diseases serious diseases - diseases - diseases important to origin eteroplastica-Patients who need surgery rhinosinusal (rhinosinusitis chronic or acute rhinosinusitis complicated polyposis rhinosinusal) - Alleged established or active infection (infection should be excluded post through microbiological examination) - Disease-immune diseases nervous in a state-Women pregnant or might, feeding and those age fertile that, during the period of observation, should not adopt an effective method (estrogen, I.U.D., condom, diaphragm with spermicide cream, etc.). - Patients enrolled in other clinical trials in the three months prior to enrollment in the study-patients with diseases or therapies that can interfere with the assessment of treatment-Patients in the study that, in the opinion of Experimenter, have other conditions that could interfere with compliance to treatment and / or procedures set and then with the proper execution of the study - that Diseases, in the opinion of Experimenter, could not benefit from any of the treatments proposed by the study protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients with improvement in symptoms evaluated after 5 ± 2 days after the end of therapy: ≥ 70% reduction from baseline of the sum of the scores severity of the symptoms. |
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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 | No |
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) | Yes |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | 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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |