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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Seretide | Active Comparator | 50ug/250ug 1 puff twice a day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salmeterol Xinafoate and Fluticasone Propinate Powder | Drug | 50ug/250ug 1 puff twice a day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline (visit 2) in Forced expiratory volume in 1 second (FEV1) on day 28 | 28 days |
| 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 |
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Inclusion Criteria:
Patients with asthma diagnosed according to the Global INitiative for Asthma (GINA) criteria.
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jinping zheng, doctor | Contact | 020-83062869 | 18928868238@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital Of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 |
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Drug:Salmeterol Xinafoate and Fluticasone Propinate Powder for inhalation (50ug/250ug) Drug:Seretide (50ug/250ug)
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Double Blind
| Seretide | Drug | 50ug/250ug 1 puff twice a day for 4 weeks |
|
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |