Clinical Equivalence of Budesonide HFA MDI Versus Budesonide Turbuhaler in Mild to Moderate Chinese Asthma Patients
NCT ID: NCT05152355
Last Updated: 2021-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
270 participants
INTERVENTIONAL
2019-04-22
2021-05-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Budesonide HFA MDI (Treatment A)
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 200 microgram/Puff, HFA MDI
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.
Budesonide DPI (Turbuhaler) (Treatment B)
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
Budesonide 100 microgram/Actuation Powder for Inhalation
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.
Interventions
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Budesonide 200 microgram/Puff, HFA MDI
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.
Budesonide 100 microgram/Actuation Powder for Inhalation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed as Asthma according to the 2016 Asthma guidance of Chinese Thoracic Society, and without administer corticosteroids within three months, either new or old patients
* FEV1 predicted ≧ 60%
* Patients is willing to participate the study and signed the Informed Consent Form
Exclusion Criteria
* Infections of Respiratory tract, nasal-sinus and ear within 4 weeks before enrollment
* Severe nasal allergy and need the treatment of corticostreoids and histamines.
* Severe cardiovascular disease history
* Has used leukotriene receptor antagonist (Montelukast, Pranlukast, Zafirlukast etc.) within 2 weeks before enrollment
* Severe cognition or mental disorder and can not cooperation with the treatment
* Significant liver dysfunction, AST, ALT \> 3 X normal upper limits, CR \> 1.5 X normal upper limits
* Patients with uncontrolled diabetes or fasting blood glucose \> 10 mmol/L
* Patients currently receiving beta-antagonists or beta-agonists treatment (including eye drops)
* Patients who has contraindications to beta2-agonists
* Patients who has participated others drug's clinical study within three months
* Female patients who are pregnant or lactation or prepare to pregnant
* Any conditions which the investigators considered not suitable to enrolled
18 Years
70 Years
ALL
No
Sponsors
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GCP ClinPlus Co., Ltd.
UNKNOWN
Beijing Aicomer Pharmaceutical Technology Co., Ltd.
UNKNOWN
Key Tech
UNKNOWN
Healthcare Inc
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
Intech Biopharm Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wei Hsiu Wu, MBA
Role: STUDY_CHAIR
Intech Biopharm
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Daqing Oil Field Hospital
Daqing, Heilongjiang, China
Bao Gang Hospital
Baotou, Inner Mongolia, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China
Meiheko Central Hospital
Tonghua, Jilin, China
Affiliated Hospital of Jining Medical University
Jining, Shandon, China
QingDao Municipal Hospital
Qingdao, Shandon, China
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Tianjin First Central Hospital
Tianjin, , China
Countries
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Other Identifiers
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INTB011H01
Identifier Type: -
Identifier Source: org_study_id