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 sites in 1 country332 target enrollmentDecember 2010

ConditionsAsthma

InterventionsBudesonide dry powder inhaler

DrugsBudesonide dry powder inhaler

Overview

Phase: Phase 2
Intervention: Budesonide dry powder inhaler
Conditions: Asthma
Sponsor: NovaMed Pharmaceuticals Inc.
Enrollment: 332
Locations: 11
Primary Endpoint: 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
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

October 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NovaMed Pharmaceuticals Inc.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Budesonide, Novolizer

Budesonide Dry Powder Inhaler

Intervention: Budesonide dry powder inhaler

BudesonideTurbuhaler

Budesonide Dry Powder Inhaler

Intervention: Budesonide dry powder inhaler

Outcomes

Primary Outcomes

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

The change of mPEF in the Week 11-12 of treatment from baseline

Secondary Outcomes

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)