NCT01269437Unknown2 期
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
NovaMed Pharmaceuticals Inc.11 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 332
- 试验地点
- 11
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Budesonide, Novolizer
Experimental
Budesonide Dry Powder Inhaler
干预措施: Budesonide dry powder inhaler (Drug)
BudesonideTurbuhaler
Active Comparator
Budesonide Dry Powder Inhaler
干预措施: Budesonide dry powder inhaler (Drug)
结局指标
主要结局
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
时间窗: 12 weeks
The change of mPEF in the Week 11-12 of treatment from baseline
次要结局
- 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(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(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(12 weeks)
- To evaluate the tolerability and safety of budesonide delivered by Novolizer or Turbuhaler in Chinese mild to moderate asthma patients(15 weeks)
研究者
研究点 (11)
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