Efficacy and Safety Study of Budesonide Novolizer Dry Powder Inhaler 200μg to Treat Chinese Patients With Mild to Moderate Asthma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide dry powder inhaler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent by the subject and his/her legal guardian if the subject is under 18 years old. 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: Asthma exacerbation leading to hospitalization for more than 2 days within the last 6 months or emergency room visit due to asthma exacerbation in the last 3 months prior to screening 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)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide, Novolizer<br>Budesonide Dry Powder Inhaler | Drug: Budesonide dry powder inhaler<br>* 200mcg per inhalation, twice daily, for 12 weeks<br>|
| Active Comparator: BudesonideTurbuhaler<br>Budesonide Dry Powder Inhaler | Drug: Budesonide dry powder inhaler<br>* 200mcg per inhalation, twice daily, for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild to moderate asthma