Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma

Study Overview
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Brief Summary
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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.

Official Title
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Salmeterol Xinafoate and Fluticasone Propinate Powder for Inhalation for Asthma: A Randomized, Double-blind, Double-dummy, Positive-controlled, Parallel-group Trail

Conditions
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Asthma

Intervention / Treatment
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* Drug: Salmeterol Xinafoate and Fluticasone Propinate Powder
* Drug: Seretide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Drug：Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) Drug：Seretide (50ug/250ug)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salmeterol Xinafoate and Fluticasone Propinate Powder<br>Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) 50ug/250ug 1 puff twice a day for 4 weeks | Drug: Salmeterol Xinafoate and Fluticasone Propinate Powder<br>* 50ug/250ug 1 puff twice a day for 4 weeks<br>|
| Active Comparator: Seretide<br>50ug/250ug 1 puff twice a day for 4 weeks | Drug: Seretide<br>* 50ug/250ug 1 puff twice a day for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (visit 2) in Forced expiratory volume in 1 second (FEV1) on day 28 |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline (visit 2) in Forced vital capacity (FVC) on day 28 |  | 28 days | 
| FEV1 AUC0-12h | The Forced expiratory volume in 1 second of area under the curve from 0h to 12h on day 1 | 12 hours | 
| PEF | The mean of morning and night peak expiratory flow | 28 days | 
| The mean of morning and night Asthma symptom scores | the outcomes are respectively: Day-1 day-7,Day1 day7,Day8 day14,Day15 day21,Day22 day28 | up to 28 days | 
| The mean of peak expiratory flow (PEF)variation of morning and night |  | up to 28 days | 
| Use of ventolin during the treatment |  | 28 days | 
| Number of asthma acute exacerbations with subjects |  | 28 days | 
| Subject self- questionare at visit 4 | questionare respectively have significant effectiveness , effectiveness ,Invalid , Deterioration | 28 days | 
| Questionnaire of Asthma control test scores | 25 score reprent Partially controlled；20-25 score represent fully controlled;<20 score represent not controlled | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized, double-blind, double-dummy, positive-controlled, parallel-group