An open-label, randomized, comparative study of the preventive efficacy and safety of Asmidine Spray, metered-dose inhaler versus Salbutamol, metered-dose inhaler, in patients with partially controlled asthma.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- VITROBIO SAS
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Change in the PEF1
研究概览
简要总结
Bronchial asthma (BA) is a heterogeneous disease,characterized by chronic inflammation of the respiratory tract, and accompaniedby respiratory symptoms such as wheezing, dyspnea, chest congestion and cough.These signs vary in duration and intensity and manifest along with variableairway obstruction.
Today,BA is a global health problem. According to the World Health Organization(WHO), approximately 235 million people worldwide suffer from BA, of whichabout 250,000 people die each year.
The Asmidine Spray under study is a film forming, polymeric, osmoticliquid spray directed for the preventive treatment of asthmatic attacks. Thespray liquid forms a stable (4-6h) and absorbent film on the nasal surfaceimmediately after application. The film acts like a physical barrier againstexternal asthma triggering contaminants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 8.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Signed Informed consent form for participation in the clinical study. 2 6.Forced expiratory volume.
- •1 second (FEV1) before the use of broncholytics not less than 60% of proper value (at screening visit or at the moment of test within 30 days before screening visit). 3 Positive result of the test for reversibility of airway obstruction, expressed as ΔFEV1 ≥12% and ≥200 ml vs.
排除标准
- •1 Diagnosis of COPD, established according to the GOLD guidelines, ver.
- •2 6.Conditions requiring the use of systemic GCS at the time of the screening visit.
- •3.Unexpected and progressive deterioration of control of symptoms of BA.
- •4.Unstable course of bronchial asthma, hospitalization due to exacerbation of bronchial asthma in the intensive care unit using intubation, frequent exacerbations of asthma 5.Pulmonary tuberculosis (active or inactive form).
- •covid positve.
结局指标
主要结局
Change in the PEF1
时间窗: weeks 1, 4, 8 and 12.
次要结局
- Evolution of the PEF value(as measured at Visits 2, 3 and 4.)
- Changes in FEV1 value(2 hours after the inhalation of the study/reference product.)
- Changes of the index according to the ACQ-5 questionnaire for evaluation of BA control(from baseline.)