EUCTR2007-001435-63-IT进行中（未招募）不适用
AEROSOLIC TREATMENT OF ACUTE AND RECURRENT RHINOSINUSITIS DURING INTERCRITICAL STAGES : SINGLE BLIND CLINICAL STUDY, N-ACETYLCISTEIN VS AMBROXOL, ASSOCIATED WITH CORTISONE THERAPY - ND
ZAMBON ITALIA0 个研究点开始时间: 2008年2月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •- 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.
研究者
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Traitement des rhinopharyngites et des bronchites aigues de l'adulte par une association de chlorydrate d'ambroxol et d'alfa-amylasees rhinopharyngites et les bronchites aigues de l'adulte constituent un vrai problème de santé publique (fréquence des consultations médicales, jours d'arrêt de travail,...). Notre étude s'inscrit dans le cadre des recommandations visant à limiter l'usage des antibiotiques par la mise en oeuvre d'un médicament associant le chlorhydrate d'ambroxol et l'alfa-amylase. Cette association semble particulièrement adaptée à la situation clinique objet de notre étude.EUCTR2007-001702-24-FRABORATOIRE TOP PHARM
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