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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by NovaMed Pharmaceuticals Inc..
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
NovaMed Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT01269437
First received: December 31, 2010
Last updated: August 22, 2011
Last verified: April 2011
  Purpose
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.

Condition Intervention Phase
Asthma
Drug: Budesonide dry powder inhaler
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NovaMed Pharmaceuticals Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change of mPEF in the Week 11-12 of treatment from baseline


Secondary Outcome Measures:
  • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change of FEV1 in the Week 12 of treatment from baseline

  • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change of ePEF in the Week 11-12 of treatment from baseline

  • 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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The change of ACT scores in the Week 12 of treatment from baseline

  • To evaluate the tolerability and safety of budesonide delivered by Novolizer or Turbuhaler in Chinese mild to moderate asthma patients [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
    It will be assessed according to numbers of adverse event and laboratory results


Estimated Enrollment: 332
Study Start Date: December 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269437

Locations
China, Beijing
The Second Artillery General Hospital of PLA
Beijing, Beijing, China
China, Guangdong
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
China, Jiangsu
Zhongda Hospital of Southeast University
Nanjing, Jiangsu, China
China, Liaoning
Shengjing Hospital
Shenyang, Liaoning, China
China, Shanghai
Dongfang Hospital Affiliated to Tongji University
Shanghai, Shanghai, China
Putuo District Hospital
Shanghai, Shanghai, China
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai, China
China, Shenyang
The General Hospital of Shenyang Military Region
Shenyang, Shenyang, China
Sponsors and Collaborators
NovaMed Pharmaceuticals Inc.
Investigators
Principal Investigator: Chunxue BAI, MD, PhD Shanghai Zhongshan Hospital
  More Information

Responsible Party: NovaMed Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01269437     History of Changes
Other Study ID Numbers: NM2010002 
Study First Received: December 31, 2010
Last Updated: August 22, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by NovaMed Pharmaceuticals Inc.:
mild to moderate asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on December 05, 2016