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This is an open-label, randomized, parallel Group, multicenter study to evaluate the efficacy and safety of budesonide novolizer dry powder inhaler compared with budesonide turbuhaler dry powder inhaler in Chinese mild to moderate asthma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide, Novolizer | Experimental | Budesonide Dry Powder Inhaler |
|
| BudesonideTurbuhaler | Active Comparator | Budesonide Dry Powder Inhaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide dry powder inhaler | Drug | 200mcg per inhalation, twice daily, for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the non-inferiority of budesonide delivered by Novolizer to that delivered by Turbuhaler in terms of mPEF (morning peak expiratory flow) in Chinese mild to moderate asthma patients | The change of mPEF in the Week 11-12 of treatment from baseline | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the improvement of FEV1(Forced Expiratory Volume in One Second) in Chinese mild to moderate asthma patients after treatment of budesonide delivered by Novolizer or Turbuhaler | The change of FEV1 in the Week 12 of treatment from baseline | 12 weeks |
| To evaluate the improvement of ePEF (Evening Peak Expiratory Flow) in Chinese mild to moderate asthma patients after treatment of budesonide delivered by Novolizer or Turbuhaler |
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Inclusion Criteria:
Exclusion Criteria:
Limitations:
The following medications are prohibited from screening onward:
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| Name | Affiliation | Role |
|---|---|---|
| Chunxue BAI, MD, PhD | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Artillery General Hospital of PLA | Recruiting | Beijing | Beijing Municipality | China |
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The change of ePEF in the Week 11-12 of treatment from baseline |
| 12 weeks |
| To evaluate the improvement in ACT (Asthma Control Test) score in Chinese mild to moderate asthma patients after treatment of budesonide delivered by Novolizer or Turbuhaler | The change of ACT scores in the Week 12 of treatment from baseline | 12 weeks |
| To evaluate the tolerability and safety of budesonide delivered by Novolizer or Turbuhaler in Chinese mild to moderate asthma patients | It will be assessed according to numbers of adverse event and laboratory results | 15 weeks |
| The First Affiliated Hospital of Foshan | Recruiting | Foshan | Guangdong | China |
|
| Guangzhou First Municipal People's Hospital | Recruiting | Guangzhou | Guangdong | China |
|
| The First Affiliated Hospital of Guangzhou Medical College, Guangzhou Institute of Respiratory Disease | Recruiting | Guangzhou | Guangdong | China |
|
| Zhongda Hospital of Southeast University | Recruiting | Nanjing | Jiangsu | China |
|
| Shengjing Hospital | Recruiting | Shenyang | Liaoning | China |
|
| Dongfang Hospital Affiliated to Tongji University | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Putuo District Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| Shanghai Pulmonary Hospital | Withdrawn | Shanghai | Shanghai Municipality | China |
| Zhongshan Hospital affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
|
| The General Hospital of Shenyang Military Region | Recruiting | Shenyang | Shenyang | 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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