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

NCT01269437 | Unknown Phase 2 DMC

• 1 other identifier: NM2010002
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Asthma

Keywords

mild to moderate asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

Budesonide, Novolizer

EXPERIMENTAL

Budesonide Dry Powder Inhaler

Drug: Budesonide dry powder inhaler

BudesonideTurbuhaler

ACTIVE COMPARATOR

Budesonide Dry Powder Inhaler

Drug: Budesonide dry powder inhaler

Interventions

Budesonide dry powder inhaler DRUG

200mcg per inhalation, twice daily, for 12 weeks

Budesonide, Novolizer; BudesonideTurbuhaler

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NovaMed Pharmaceuticals Inc.: lead

Study Sites (11)

The Second Artillery General Hospital of PLA

Beijing, Beijing Municipality, China

RECRUITING

The First Affiliated Hospital of Foshan

Foshan, Guangdong, China

RECRUITING

Guangzhou First Municipal People's Hospital

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical College, Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, China

RECRUITING

Zhongda Hospital of Southeast University

Nanjing, Jiangsu, China

RECRUITING

Shengjing Hospital

Shenyang, Liaoning, China

RECRUITING

Dongfang Hospital Affiliated to Tongji University

Shanghai, Shanghai Municipality, China

RECRUITING

Putuo District Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

WITHDRAWN

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

The General Hospital of Shenyang Military Region

Shenyang, Shenyang, China

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Chunxue BAI, MD, PhD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2010
• First Posted: January 4, 2011
• Study Start: December 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 23, 2011

Record last verified: 2011-04

Locations

CN (11)