Patients with acute recurrent rhinosinusitis(intercritical stages) MedDRA version: 9.1 Level: LLT Classification code 10001076 Term: Acute sinusitis
Conditions
Interventions
Trade Name: FLUIBRON*AER 20FL 2ML 15MG/2ML
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Ambroxol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Sponsors
ZAMBON ITALIA
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: - 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;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. | — |
Countries
Italy
Outcome results
None listed