Efficacy and Safety Study of Budesonide Novolizer Dry Powder Inhaler 200μg to Treat Chinese Patients With Mild to Moderate Asthma
NCT ID: NCT01269437
Last Updated: 2011-08-23
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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UNKNOWN
PHASE2/PHASE3
332 participants
INTERVENTIONAL
2010-12-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Budesonide, Novolizer
Budesonide Dry Powder Inhaler
Budesonide dry powder inhaler
200mcg per inhalation, twice daily, for 12 weeks
BudesonideTurbuhaler
Budesonide Dry Powder Inhaler
Budesonide dry powder inhaler
200mcg per inhalation, twice daily, for 12 weeks
Interventions
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Budesonide dry powder inhaler
200mcg per inhalation, twice daily, for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Male or females aged more than 12 and under 70
* Had a definite diagnosis of asthma with symptoms of cough/expectoration/chest tightness/wheeze/breathlessness within the last one month
* Inhaled corticosteroid (ICS) naïve or no regular use of ICS within the last one month (It is suggested that ICS average daily dose with no more than 100mg budesonide or equal within the last month as "No-regular-use")
* FEV1 between 60% and 85% of predicted normal values
* Reversibility test of airway obstruction is positive, i.e. degree of reversibility in FEV1 as over 12%(included) and 200ml(included). Or average diurnal PEFR variability is not less than 20% in two weeks.
* Are able to use Peak Flow Meter and record it on patient diary card
Exclusion Criteria
* Infection of respiratory system in the last 4 weeks prior to screening visit
* Use of oral, injectable, rectal or transdermal glucocorticoid in the last 4 weeks prior to screening visit
* Use of Leukotriene receptor antagonist (LTRAs), oral b2 agonist, methylxanthines or use of inhaled long acting b2 agonist, inhaled anticholinergic receptor in the last 1 week, or inhaled Tiotropium Bromide within 45 days prior to screening visit
* Patients with chronic obstructive pulmonary disease (COPD)or COPD with asthma
* Patients with severe persistent asthma (Based on definition in GINA 2006)
* Patients with specific immunity treatment (including monoclonal antibody treatment) due to asthma within the 6 months prior to screening visit
* Patients with eye disorders including cataract, glaucoma and herpes virus infection
* Smoking history of 10 pack-year (1 pack-year refers to 20 cigarette per day for 1 year)
* History of drug or alcohol abuse
* History of adrenal disease
* History of malignancy disease in the last 5 years, with the exception of basal cell carcinoma
* Heart function failure or any severe systematic disease, at the investigator's discretion, which will make it undesirable for the patient to participate in the trial or which could jeopardize compliance with the trial protocol
* ALT or AST \> 2 times of upper limit of reference range
* Creatinine (Cr) \> 159µmol/L for males or \> 141µmol/L for females
* Patients with hypersensitivity to budesonide and/or lactose
* Participation in a clinical study or treatment with a non-approved experimental medication in the last 1 month
* Pregnant or breast-feeding women, or women of childbearing age without appropriate contraception measures
Limitations:
The following medications are prohibited from screening onward:
* Use of oral, injectable, rectal or transdermal glucocorticoid
* Inhaled nedocromil sodium/Inhaled cromoglycate sodium
* Leukotriene receptor antagonist
* Methylxanthines
* Inhaled long acting b2 agonist
* Oral b2 agonist
* Inhaled anticholinergic receptor
* Any b2 receptor blocker (Including eye drops)
12 Years
70 Years
ALL
No
Sponsors
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NovaMed Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Chunxue BAI, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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The Second Artillery General Hospital of PLA
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Foshan
Foshan, Guangdong, China
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical College, Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong, China
Zhongda Hospital of Southeast University
Nanjing, Jiangsu, China
Shengjing Hospital
Shenyang, Liaoning, China
Dongfang Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China
Putuo District Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
The General Hospital of Shenyang Military Region
Shenyang, Shenyang, China
Countries
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Facility Contacts
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Yongjie LIANG
Role: primary
Other Identifiers
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NM2010002
Identifier Type: -
Identifier Source: org_study_id
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