AEROSOLIC TREATMENT OF ACUTE AND RECURRENT RHINOSINUSITIS DURING INTERCRITICAL STAGES : SINGLE BLIND CLINICAL STUDY, N-ACETYLCISTEIN VS AMBROXOL, ASSOCIATED WITH CORTISONE THERAPY - ND
- Conditions
- Patients with acute recurrent rhinosinusitis(intercritical stages)MedDRA version: 9.1Level: LLTClassification code 10001076Term: Acute sinusitis
- Registration Number
- EUCTR2007-001435-63-IT
- Lead Sponsor
- ZAMBON ITALIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method