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| Name | Class |
|---|---|
| GCP ClinPlus Co., Ltd. | UNKNOWN |
| Beijing Aicomer Pharmaceutical Technology Co., Ltd. | UNKNOWN |
| Key Tech | UNKNOWN |
| Healthcare Inc |
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The primary objective of this study is to compare the efficacy and safety of budesonide HFA MDI 200 mcg 2 puffs BID versus budesonide DPI (Turbuhaler) 100 mcg 4 puffs BID in Chinese mild to moderate Asthma patients.
A total of 270 Chinese mild to moderate Asthma patients will be enrolled and 230 will be completed in this multi-center, randomized, single blind, parallel efficacy and safety comparison study of budesonide HFA MDI 200 mcg 2 puffs BID versus budesonide DPI (Turbuhaler) 100 mcg 4 puffs BID.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide HFA MDI (Treatment A) | Experimental | Participants assigned to Experimental arm will inhaled 2 puffs of budesonide 200 mcg HFA MDI bid (am 08:00 and pm 16:00) for 4 weeks |
|
| Budesonide DPI (Turbuhaler) (Treatment B) | Active Comparator | Participants assigned to Active Comparator arm will inhaled 4 puffs of budesonide 100 mcg powder for inhalation bid (am 08:00 and pm 16:00) for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide 200 microgram/Puff, HFA MDI | Drug | Participants will inhaled 2 puffs of budesonide 200 mcg HFA MDI bid (am 08:00 and pm 16:00) for 4 weeks, if necessary rescue Ventolin (Salbutamol Sulfate) 100 mcg 2 puffs could be used with maximum daily dose of 8 puffs. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from base line of FEV1 | The change from base line of forced expiratory volume in one second after 4 weeks treatment | Week 0, 2 and 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from base line of morning and evening PEF | The mean change from base line of morning and evening PEF (peak expiratory flow) | Week 0 and 4 |
| Change from base line of FVC | The changes from base line of FVC after 4 weeks treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Hsiu Wu, MBA | Intech Biopharm | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China | ||
| The First Affiliated Hospital of Jinan University |
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| UNKNOWN |
| Peking University People's Hospital | OTHER |
| Beijing Friendship Hospital | OTHER |
| Tianjin First Central Hospital | OTHER |
| Bao Gang Hospital | UNKNOWN |
| The Affiliated Hospital of Inner Mongolia Medical University | OTHER |
| Beijing Yi Hua Hospital Management Co., Ltd | UNKNOWN |
| The Second Hospital of Hebei Medical University | OTHER |
| The First Affiliated Hospital of Shanxi Medical University | OTHER |
| Shaanxi Provincial People's Hospital | OTHER |
| Jining Medical University | OTHER |
| Qingdao Municipal Hospital | OTHER |
| Daqing Oil Field Hospital | OTHER |
| First Affiliated Hospital of Jinan University | OTHER |
| Meizhou People's Hospital | OTHER |
| Meiheko Central Hospital | UNKNOWN |
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Single blind
|
| Budesonide 100 microgram/Actuation Powder for Inhalation | Drug | Participants will inhaled 4 puffs of budesonide 100 mcg DPI bid (am 08:00 and pm 16:00) for 4 weeks, if necessary rescue Ventolin (Salbutamol Sulfate) 100 mcg 2 puffs could be used with maximum daily dose of 8 puffs. |
|
|
| Week 0 and 4 |
| Change from base line of FEV1/FVC ratio | The changes from base line of FEV1/FVC ratio after 4 weeks treatment | Week 0 and 4 |
| Change from base line of FEF25% | The changes from base line of FEF25% after 4 weeks treatment | Week 0 and 4 |
| Change from base line of FEF50% | The changes from base line of FEF50% after 4 weeks treatment | Week 0 and 4 |
| Change from base line of FEF75% | The changes from base line of FEF75% after 4 weeks treatment | Week 0 and 4 |
| Change from base line of ACT | The change from base line of Asthma Control Test after 4 weeks treatment | Week 0, 2 and 4 |
| Daily PEF variability | The Daily PEF variability (= (daily highest PEF-daily lowest PEF)X2/((daily highest PEF+daily lowest PEF) X 100% during the whole treatment period | during week 0 to 4 |
| Weekly PEF variability | The Weekly PEF variability (= (biweely highest PEF-biweekly lowest PEF)X2/((biweekly highest PEF+biweekly lowest PEF) X 100% during the whole treatment period | during week 0 to 4 |
| Changes of day time and night time symptom | The changes of day time and night time symptom during the treatment period | during week 0 to 4 |
| Subjects number with acute exacerbation | The total number of subjects with acute exacerbation during treatment period | during week 0 to 4 |
| Total amount of rescue medication, Ventolin 100 mcg inhaler, used | The total amount of doses of rescue medication, Ventolin 100 mcg inhaler, used during the treatment period | during week 0 to 4 |
| Percentage of days without symptom | The percentage of days without asthma symptom during the treatment period | during week 0 to 4 |
| Percentage of days without using rescue medicine | The percentage of days without using rescue medicine during the treatment period | during week 0 to 4 |
| Guangzhou |
| Guangdong |
| 510650 |
| China |
| Meizhou People's Hospital | Meizhou | Guangdong | 514031 | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050017 | China |
| Daqing Oil Field Hospital | Daqing | Heilongjiang | 163411 | China |
| Bao Gang Hospital | Baotou | Inner Mongolia | 014000 | China |
| The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | 010100 | China |
| Meiheko Central Hospital | Tonghua | Jilin | China |
| Affiliated Hospital of Jining Medical University | Jining | Shandon | 272000 | China |
| QingDao Municipal Hospital | Qingdao | Shandon | 266011 | China |
| The First Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi | 030001 | China |
| Shanxi Provincial People's Hospital | Taiyuan | Shanxi | 030012 | China |
| Tianjin First Central Hospital | Tianjin | 300393 | China |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| D001239 | Inhalation |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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