Chronic Obstructive Pulmonary DiseasePhase 3NCT00421122
Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD
A Phase 3 study testing budesonide/formoterol (Symbicort), budesonide (Pulmicort) and terbutaline sulfate (Bricasol) in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 8 sites in China.
Trial summary
This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD patients as defined by GOLD treatment guidelines in order to obtain an approval for indication of COPD from Chinese State Food and Drug Administration. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- budesonide/formoterol (Symbicort), budesonide (Pulmicort) and terbutaline sulfate (Bricasol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 8 sitesChina
- Study dates
- Sep 2006to Nov 2007
- Phase
- Phase 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated inform consent
- Out-patient, clinical diagnosis of COPD
- Men or women at the age of 40 or over
Who cannot join
- A history of asthma
- Seasonal allergic rhinitis before 40 years of age
- Patients with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator or other disorder
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Research Site
Beijing, Beijing Municipality
Research Site
Chengdu, Sichuan
Research Site
Guangzhou, Guangdong
Research Site
Hangzhou, Zhejiang
Research Site
Nanjing, Jiangsu
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang, Liaoling
Research Site
Xi’an, Shanxi
About this study
Official title: A 6-Month, Phase IIIA, Multi-Center,Randomised,Double-Blind, Double-Dummy, Parallel-Group Study of the Efficacy and Safety of Symbicort® Turbuhaler®+ Bricasol® pMDI Compared With Pulmicort® Turbuhaler®+Bricasol® pMDI in Chinese Patients With COPD
This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD patients as defined by GOLD treatment guidelines in order to obtain an approval for indication of COPD from Chinese State Food and Drug Administration.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- budesonide/formoterol (Symbicort), budesonide (Pulmicort), terbutaline sulfate (Bricasol)
- Keywords
- Chinese patients, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonide/formoterol (Symbicort)Drug
Also called Symbicort® Turbuhaler
inhalation therapy
budesonide (Pulmicort)Drug
Also called Pulmicort® Turbuhaler
inhalation
terbutaline sulfate (Bricasol)Drug
Also called Bricasol pMDI
inhalation therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Bricasol® Receives: Drug: terbutaline sulfate (Bricasol) |
| 2 | Experimental | Bricasol® + Pulmicort® Receives: Drug: budesonide (Pulmicort); Drug: terbutaline sulfate (Bricasol) |
| 3 | Experimental | Bricasol® + Symbicort® Receives: Drug: budesonide/formoterol (Symbicort); Drug: terbutaline sulfate (Bricasol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-study medication FEV1
Measured: 1 hour after medication
Secondary outcomes (11)
FVC
Measured: Pre dose and 1 hour post dose
FEV1
Measured: Pre-dose and 15 minutes post dose
SGRQ symptom scores
COPD symptom scores
morning and evening PEF
Measured: Assessed daily
reliever medication use
AE
lab measures
ECG
physician examination
vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startSep 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Symbicort Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421122
- Sponsor's protocol ID
- D5892C00013
- Status last verified
- Mar 2009
- First submitted
- 9 Jan 2007
- Last updated
- 27 Mar 2009
- Results posted
- No
Publications
Zhong N, Zheng J, Wen F, Yang L, Chen P, Xiu Q, Yao W, Sun T, Zhao Z, Shen H, Shi Y, Lin J, Li Q. Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease. Curr Med Res Opin. 2012 Feb;28(2):257-65. doi: 10.1185/03007995.2011.636420. Epub 2012 Jan 20.
PubMed 22046961
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month, Phase IIIA, Multi-Center,Randomised,Double-Blind, Double-Dummy, Parallel-Group Study of the Efficacy and Safety of Symbicort® Turbuhaler®+ Bricasol® pMDI Compared With Pulmicort® Turbuhaler®+Bricasol® pMDI in Chinese Patients With COPD
- ClinicalTrials.gov ID
- NCT00421122
- Acronym / sponsor ID
- D5892C00013
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chinese patients, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 11 Jan 2007 (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 study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD patients as defined by GOLD treatment guidelines in order to obtain an approval for indication of COPD from Chinese State Food and Drug Administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: terbutaline sulfate (Bricasol)Bricasol® |
| 2 | Experimental | Drug: budesonide (Pulmicort), Drug: terbutaline sulfate (Bricasol)Bricasol® + Pulmicort® |
| 3 | Experimental | Drug: budesonide/formoterol (Symbicort), Drug: terbutaline sulfate (Bricasol)Bricasol® + Symbicort® |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed and dated inform consent
- Out-patient, clinical diagnosis of COPD
- Men or women at the age of 40 or over
Key exclusion criteria (3 listed)
- A history of asthma
- Seasonal allergic rhinitis before 40 years of age
- Patients with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator or other disorder
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/formoterol (Symbicort)Also: Symbicort® Turbuhalerinhalation therapy | Drug | 3 |
| budesonide (Pulmicort)Also: Pulmicort® Turbuhalerinhalation | Drug | 2 |
| terbutaline sulfate (Bricasol)Also: Bricasol pMDIinhalation therapy | Drug | 1, 2, 3 |
Primary outcome
Post-study medication FEV1
Time frame: 1 hour after medication
11 secondary outcomes
FVC
Time frame: Pre dose and 1 hour post dose
FEV1
Time frame: Pre-dose and 15 minutes post dose
SGRQ symptom scores
COPD symptom scores
morning and evening PEF
Time frame: Assessed daily
reliever medication use
AE
lab measures
ECG
physician examination
vital signs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2009.
- Derived from this study: PubMed 22046961Zhong N, Zheng J, Wen F, Yang L, Chen P, Xiu Q, Yao W, Sun T, Zhao Z, Shen H, Shi Y, Lin J, Li Q. Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease. Curr Med Res Opin. 2012 Feb;28(2):257-65. doi: 10.1185/03007995.2011.636420. Epub 2012 Jan 20.
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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.
Symbicort Medical Science Director, MD study director
AstraZeneca
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing budesonide/formoterol (Symbicort), budesonide (Pulmicort) and terbutaline sulfate (Bricasol) in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 8 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-study medication FEV1 (time frame: 1 hour after medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00421122, which also lists 1 linked publication.
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 27 Mar 2009.