AsthmaPhase 2/3NCT01269437
Efficacy and Safety Study of Budesonide Novolizer Dry Powder Inhaler 200μg to Treat Chinese Patients With Mild to Moderate Asthma
A Phase 2/3 study testing Budesonide dry powder inhaler in people with Asthma, run by NovaMed Pharmaceuticals Inc. at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide dry powder inhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 11 sitesChina
- Study dates
- Dec 2010to Oct 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 28Show fewer
- 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)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites, 10 recruiting
- Recruiting
The Second Artillery General Hospital of PLA
Beijing, Beijing Municipality
Suiyang ZHANG, +86 13693652527, suiyangzhang@yahoo.com
Ai'E WANG
- Recruiting
The First Affiliated Hospital of Foshan
Foshan, Guangdong
Zhiyang LUO, +86 13929930368, zhiyangluo@yahoo.com.cn
Zhiyang LUO
- Recruiting
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong
Ziwen ZHAO, Professor, +86 13006872260, zhaozw@yeah.net
Ziwen ZHAO
- Recruiting
The First Affiliated Hospital of Guangzhou Medical College, Guangzhou Institute of Respiratory Disease
Guangzhou, Guangdong
Kefang LAI, Professor, +86 13719138526, klai@163.com
Kefang LAI
- Recruiting
Zhongda Hospital of Southeast University
Nanjing, Jiangsu
Yong LIN, Professor, +86 13951899504, linyong63@163.com
Yong LIN
- Recruiting
Dongfang Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality
Yongjie LIANG, +86 21 38804518 ext. 6191
Yongjie LIANG
- Recruiting
Putuo District Hospital
Shanghai, Shanghai Municipality
Xiongbiao WANG, +86 021 62572723, xiongbiao6@hotmail.com
Xiongbiao WANG
- Withdrawn
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality
- Recruiting
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality
Chunxue BAI, +86 13681971807, bai.chunxue@zs-hospital.sh.cn
Chunxue BAI, Professor
- Recruiting
Shengjing Hospital
Shenyang, Liaoning
Li ZHAO, +86 024 96615-21121, zhaol@sj-hospital.org
Yu LI
- Recruiting
The General Hospital of Shenyang Military Region
Shenyang, Shenyang
Ping CHEN, Professor, +86 13309887193, cp59620@sina.com
Haitao ZHAO
About this study
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
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
- Being tested
- Budesonide dry powder inhaler
- Keywords
- mild to moderate asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide dry powder inhalerDrug
200mcg per inhalation, twice daily, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Budesonide, Novolizer | Experimental | Budesonide Dry Powder Inhaler Receives: Drug: Budesonide dry powder inhaler |
| BudesonideTurbuhaler | Active comparator | Budesonide Dry Powder Inhaler Receives: Drug: Budesonide dry powder inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The change of FEV1 in the Week 12 of treatment from baseline
Measured: 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
Measured: 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
Measured: 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
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaMed Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chunxue BAI, MD, PhD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269437
- Sponsor's protocol ID
- NM2010002
- Status last verified
- Apr 2011
- First submitted
- 31 Dec 2010
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01269437
- Acronym / sponsor ID
- NM2010002
- Conditions
- Asthma
- Keywords
- mild to moderate asthma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- NovaMed Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide, Novolizer | Experimental | Drug: Budesonide dry powder inhalerBudesonide Dry Powder Inhaler |
| BudesonideTurbuhaler | Active comparator | Drug: Budesonide dry powder inhalerBudesonide Dry Powder Inhaler |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide dry powder inhaler200mcg per inhalation, twice daily, for 12 weeks | Drug | Budesonide, Novolizer, BudesonideTurbuhaler |
Primary outcome
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
4 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
Time frame: 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
Time frame: 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
Time frame: 12 weeks
To evaluate the tolerability and safety of budesonide delivered by Novolizer or Turbuhaler in Chinese mild to moderate asthma patients
Time frame: 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunxue BAI, MD, PhD principal investigator
Shanghai Zhongshan Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Budesonide dry powder inhaler in people with Asthma, run by NovaMed Pharmaceuticals Inc. at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2011.