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

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

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.

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Drug: Budesonide dry powder inhaler

• Study Type: Interventional
• Enrollment (Anticipated): 332
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • The Second Artillery General Hospital of PLA
      • Sub-Investigator: Hong ZHANG
      • Contact: Suiyang ZHANG; Phone Number: +86 13693652527; Email: suiyangzhang@yahoo.com
      • Sub-Investigator: Ai'E WANG
      • Principal Investigator: Suiyang ZHANG
      • Sub-Investigator: Kaicheng MEI
      • Sub-Investigator: Jianxin MA
      • Sub-Investigator: Chuanlian YAN
      • Sub-Investigator: Dongxia WANG
      • Sub-Investigator: Chaoxia LI
      • Sub-Investigator: Ying Wang
  • Guangdong
    • Foshan, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Foshan
      • Contact: Zhiyang LUO; Phone Number: +86 13929930368; Email: zhiyangluo@yahoo.com.cn
      • Principal Investigator: Zhiyang LUO
      • Sub-Investigator: Gang CHEN
      • Sub-Investigator: Yueming LIANG
      • Sub-Investigator: Jian LIU
      • Sub-Investigator: Shaozhi HU
      • Sub-Investigator: Peifang ZHANG
      • Sub-Investigator: Yanhua FAN
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangzhou First Municipal People's Hospital
      • Principal Investigator: Ziwen Zhao
      • Contact: Ziwen ZHAO, Professor; Phone Number: +86 13006872260; Email: zhaozw@yeah.net
      • Sub-Investigator: Shuquan WEI
      • Sub-Investigator: Xiaoyan LI
      • Sub-Investigator: Zhigao XIA
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical College, Guangzhou Institute of Respiratory Disease
      • Contact: Kefang LAI, Professor; Phone Number: +86 13719138526; Email: klai@163.com
      • Principal Investigator: Kefang LAI
      • Sub-Investigator: Siqi JIANG
      • Sub-Investigator: Xu ZHANG
      • Sub-Investigator: Baojuan LIU
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Zhongda Hospital of Southeast University
      • Contact: Yong LIN, Professor; Phone Number: +86 13951899504; Email: linyong63@163.com
      • Principal Investigator: Yong LIN
      • Sub-Investigator: Qiang ZHANG
      • Sub-Investigator: Weilan LI
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • Shengjing Hospital
      • Principal Investigator: Li Zhao
      • Contact: Li ZHAO; Phone Number: +86 024 96615-21121; Email: zhaol@sj-hospital.org
      • Sub-Investigator: Yu LI
      • Sub-Investigator: Xiaoman XU
      • Sub-Investigator: Cuihong WANG
      • Sub-Investigator: Lihua ZHU
      • Sub-Investigator: Heng DAI
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Zhongshan Hospital affiliated to Fudan University
      • Contact: Chunxue BAI; Phone Number: +86 13681971807; Email: bai.chunxue@zs-hospital.sh.cn
      • Principal Investigator: Chunxue BAI, Professor
      • Sub-Investigator: Meiling JIN
      • Sub-Investigator: Dong YANG
      • Sub-Investigator: Maosong Ye
      • Sub-Investigator: Ling YE
      • Sub-Investigator: Qi CHEN
      • Sub-Investigator: Xia AN
    • Shanghai, Shanghai, China
      • Recruiting
      • Dongfang Hospital Affiliated to Tongji University
      • Contact: Yongjie LIANG; Phone Number: 6191 +86 21 38804518
      • Principal Investigator: Yongjie LIANG
      • Sub-Investigator: Qi YIN
    • Shanghai, Shanghai, China
      • Recruiting
      • Putuo District Hospital
      • Contact: Xiongbiao WANG; Phone Number: +86 021 62572723; Email: xiongbiao6@hotmail.com
      • Principal Investigator: Xiongbiao WANG
    • Shanghai, Shanghai, China
      • Withdrawn
      • Shanghai Pulmonary Hospital
  • Shenyang
    • Shenyang, Shenyang, China
      • Recruiting
      • The General Hospital Of Shenyang Military Region
      • Contact: Ping CHEN, Professor; Phone Number: +86 13309887193; Email: cp59620@sina.com
      • Sub-Investigator: Haitao ZHAO
      • Principal Investigator: Ping Chen
      • Sub-Investigator: Binbin JI
      • Sub-Investigator: Li SUN
      • Sub-Investigator: Yan WANG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 68 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NovaMed Pharmaceuticals Inc.
• Investigators: Principal Investigator: Chunxue BAI, MD, PhD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: December 31, 2010
• First Submitted That Met QC Criteria: January 3, 2011
• First Posted (Estimate): January 4, 2011

Study Record Updates

• Last Update Posted (Estimate): August 23, 2011
• Last Update Submitted That Met QC Criteria: August 22, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: mild to moderate asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: NM2010002