NCT03461627Unknown3 期
Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma: A Randomized, Double-blind, Double-dummy, Positive-controlled, Parallel-group Trail
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change from baseline (visit 2) in Forced expiratory volume in 1 second (FEV1) on day 28
研究概览
简要总结
assess the efficacy and safety of Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) in combination with seretide to patients with Asthma.
a randomized, double-blind, double-dummy, positive-controlled, parallel-group trail.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with asthma diagnosed according to the Global INitiative for Asthma (GINA) criteria.
- •Inadequate asthma control on an inhaled corticosteroids alone at a dose of ≤ 800 μg/day of budesonide, ≤ 1000μg/day of Beclomethasone; ≤ 500 μg/day of fluticasone
- •Inadequate asthma control on bronchodilators
- •Inadequate asthma control on an ICS (medium and low dose)-LABA combination
- •primarily diagnosed with asthma
- •Positive bronchodilation test [an increase in of FEV1﹥200 ml and the FEV1 change﹥12% from the baseline] or PEF variation﹥20%
- •Age between 18-70 years
- •Patients should participate in the study voluntarily and sign informed consent;
- •Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving study therapy; Male patients can participate if they are surgically sterile or males capable of having children and agree not to attempt pregnancy while receiving study therapy.
排除标准
- •Allergic to salmeterol, fluticasone propionate or to ventolin.
- •Have a current diagnosis of chronic obstructive pulmonary disease (COPD), pneumonia, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, chronic bronchitis or other respiratory tract disorders (not including asthma).
- •Any respiratory tract infection, sinus infection or eardrum infection within 4 weeks prior to the screening .visit
- •History or severe cardiovascular disease or hematopoietic system disease (congestive heart failure, clinically relevant coronary heart disease, apoplexy, clinically relevant cardiac arrhythmias, aortic aneurysm, and uncontrolled hypertension (systolic blood pressure above 160mmHg or diastolic blood pressure above 100 mmHg continuously measured more than twice.))
- •Patients treated with leukotriene antagonist, such as zafirlukast, pranlukast, and montelukast.
- •Expected medication to improve asthma other than ventolin
- •Subjects who suffer from serious, uncontrolled diseases (including psychological disorders), in researcher's opinion, under great risks.
- •Hepatic dysfunction: aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of > 2.0 × ULN; renal dysfunction: serum creatinine level of > ULN )
- •A history of both HBV infection and HCV infection.
- •In Human Immunodeficiency Virus (HIV)-positive status
- •Subjects with uncontrolled diabetics or fasting glucose > 10mmol/L
- •Use of any β-blocking agent, including eye-drops
- •In oral glucocorticoid medication or a history of systemic corticosteroid medication within 30 days of the screening visit
- •Subjects who participated in other clinical studies within 2 months
- •Subjects who have previously enrolled into this study
- •Pregnancy, breast-feeding or planned pregnancy during the study
- •Researchers think that do not fit into the group.
研究组 & 干预措施
Salmeterol Xinafoate and Fluticasone Propinate Powder
Experimental
Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) 50ug/250ug 1 puff twice a day for 4 weeks
干预措施: Salmeterol Xinafoate and Fluticasone Propinate Powder (Drug)
Seretide
Active Comparator
50ug/250ug 1 puff twice a day for 4 weeks
干预措施: Seretide (Drug)
结局指标
主要结局
Change from baseline (visit 2) in Forced expiratory volume in 1 second (FEV1) on day 28
时间窗: 28 days
次要结局
- PEF(28 days)
- The mean of peak expiratory flow (PEF)variation of morning and night(up to 28 days)
- Subject self- questionare at visit 4(28 days)
- FEV1~AUC0-12h(12 hours)
- Number of asthma acute exacerbations with subjects(28 days)
- Change from baseline (visit 2) in Forced vital capacity (FVC) on day 28(28 days)
- Questionnaire of Asthma control test scores(28 days)
- The mean of morning and night Asthma symptom scores(up to 28 days)
- Use of ventolin during the treatment(28 days)
研究者
研究点 (1)
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