Chronic Obstructive Pulmonary Disease (COPD)Phase 4SECURE 1NCT01397890
Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing Budesonide/formoterol (Symbicort® Turbuhaler®) and Tiotropium (SpirivaTM) in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 31 sites in 5 countries.
Trial summary
This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Budesonide/formoterol (Symbicort® Turbuhaler®) and Tiotropium (SpirivaTM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 793 participants
- Where
- 31 sitesin 5 countries
- Study dates
- Jul 2011to Jun 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 informed consent
- Men or women patients ≥40 years of age
- Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2
- Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) < 70%, pre-bronchodilator
- Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period
Who cannot join
- A history of asthma and seasonal allergic rhinitis before 40 years of age
- Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period and also the patients who use of systemic glucocorticosteroids (GCS) within 4 weeks and/or inhaled GCS within 2 weeks prior to Visit 2 and/or during run-in period
- Patients with relevant cardiovascular disorder judged by the investigator
- Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator
- Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator
Trial locations and contacts
31 sites in 5 countries.
31 sites in 5 countries
Thailand9 sites
Research Site
Bangkok
Research Site
Chiang Mai, Thailand
Research Site
Chon Buri
Research Site
Khon Kaen
Research Site
Muang, Changwat Nan
Research Site
Nonthaburi, Changwat Nonthaburi
Research Site
Phitsanulok
Research Site
Songkhla
Research Site
Udon Thani
China8 sites
Research Site
Beijing, Beijing Municipality
Research Site
Changchun, Jilin
Research Site
Changsha, Hunan
Research Site
Guangzhou, Guangdong
Research Site
Guangzhou
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang, Liaoning
Research Site
Taiyuan, Shanxi
South Korea8 sites
Research Site
Busan
Research Site
Daegu
Research Site
Gwangju
Research Site
Incheon
Research Site
Jinju, Gyeongsangnam-do
Research Site
Seoul
Research Site
Suwon, Gyeonggi-do
Research Site
Wŏnju, Gangwon-do
Hong Kong3 sites
Research Site
Hong Kong, Hong Kong
Research Site
Hong Kong
Research Site
Kowloon, HK
Indonesia3 sites
Research Site
Jakarta
Research Site
Solo
Research Site
Surabaya
About this study
Official title: A Randomised, Parallel-group, Open-label, Multicentre, 3-month Phase IV, Efficacy and Tolerability Study of Budesonide/Formoterol (Symbicort® Turbuhaler® 160/4.5μg/Inhalation, 2 Inhalations Twice Daily) Added to Tiotropium (SpirivaTM 18 μg/Inhalation, 1 Inhalation Once Daily) Compared With Tiotropium (SpirivaTM18 μg/Inhalation, 1 Inhalation Once Daily) Alone in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD).
- Being tested
- Budesonide/formoterol (Symbicort® Turbuhaler®), Tiotropium (SpirivaTM)
- Keywords
- Severe chronic obstructive pulmonary disease (COPD) patients
- 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® Turbuhaler®)Drug
Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily
Tiotropium (SpirivaTM)Drug
Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Add-on treatment Receives: Drug: Budesonide/formoterol (Symbicort® Turbuhaler®); Drug: Tiotropium (SpirivaTM) |
| 2 | Other | Add-on treatment Receives: Drug: Tiotropium (SpirivaTM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-dose FEV1
Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value
Measured: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug
Secondary outcomes (23)
Post-dose FEV1 at 5 Minutes
Ratio of post-dose FEV1 at 5 minutes to baseline value
Measured: Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug
Post-dose FEV1 at 60 Minutes
Ratio of post-dose FEV1 at 60 minutes to baseline value
Measured: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)
Pre-dose FVC
Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value
Measured: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)
Post-dose FVC at 5 Minutes
Ratio of post-dose FVC at 5 minutes to baseline value
Measured: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12)
Post-dose FVC at 60 Minutes
Ratio of post-dose FVC at 60 minutes to baseline value
Measured: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)
Pre-dose IC
Ratio of pre-dose IC (Inspiratory Capacity) in treatment period to baseline value
Measured: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug
Post-dose IC at 60 Minutes
Ratio of post-dose IC at 60 minutes to baseline value
Measured: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)
Pre-dose PEF in Last Week of Treatment
Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment, up to 12 weeks
Pre-dose PEF in First Week of Treatment
Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to first week of treatment
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the first week of treatment
Pre-dose PEF in Whole Treatment Period
Change in pre-dose morning PEF from run-in period to whole treatment period
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period of 12 weeks
Post-dose PEF in Last Week of Treatment
Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment, up to 12 weeks
Post-dose PEF in First Week of Treatment
Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the first week of treatment
Post-dose PEF in Whole Treatment Period
Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period of 12 weeks
Use of Reliever Medication During Day in the Last Week on Treatment
Change in the number of inhalations of reliever medication during day from run-in period to the last week on treatment
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks
Use of Reliever Medication During Day in the First Week on Treatment
Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment
Use of Reliever Medication During Day in the Whole Treatment Period
Change in the number of inhalations of reliever medication during day from run-in period to the whole treatment period
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks
Use of Reliever Medication During Night in the Last Week on Treatment
Change in the number of inhalations of reliever medication during night from run-in period to the last week on treatment
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks
Use of Reliever Medication During Night in the First Week on Treatment
Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment
Use of Reliever Medication During Night in the Whole Treatment Period
Change in the number of inhalations of reliever medication during night from run-in period to the whole treatment period
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks
Change in COPD Symptoms - Breathing
Change in breathing symptom score (from 0:none to 4:severe) from run-in period
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks
Change in COPD Symptoms - Cough
Change in Cough symptom score (from 0:none to 4:severe) from run-in period
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks
Change in COPD Symptoms - Sputum
Change in Sputum symptom score (from 0:none to 4:severe) from run-in period
Measured: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks
COPD Exacerbations
Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms
Measured: Whole treatment period of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 793 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Chen, M.D., Study chair, AstraZeneca Pharmaceutical Co., Ltd., Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397890
- Sponsor's protocol ID
- D589BL00023
- Acronym
- SECURE 1
- Status last verified
- Mar 2015
- First submitted
- 27 Jun 2011
- Last updated
- 27 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Lee SD, Xie CM, Yunus F, Itoh Y, Ling X, Yu WC, Kiatboonsri S. Efficacy and tolerability of budesonide/formoterol added to tiotropium compared with tiotropium alone in patients with severe or very severe COPD: A randomized, multicentre study in East Asia. Respirology. 2016 Jan;21(1):119-27. doi: 10.1111/resp.12646. Epub 2015 Sep 23.
PubMed 26394882
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Parallel-group, Open-label, Multicentre, 3-month Phase IV, Efficacy and Tolerability Study of Budesonide/Formoterol (Symbicort® Turbuhaler® 160/4.5μg/Inhalation, 2 Inhalations Twice Daily) Added to Tiotropium (SpirivaTM 18 μg/Inhalation, 1 Inhalation Once Daily) Compared With Tiotropium (SpirivaTM18 μg/Inhalation, 1 Inhalation Once Daily) Alone in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT01397890
- Acronym / sponsor ID
- SECURE 1 / D589BL00023
- Keywords
- Severe chronic obstructive pulmonary disease (COPD) patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 793 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Jul 2011 (estimated)
- Results
- Posted 27 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Budesonide/formoterol (Symbicort® Turbuhaler®), Drug: Tiotropium (SpirivaTM)Add-on treatment |
| 2 | Other | Drug: Tiotropium (SpirivaTM)Add-on treatment |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed and dated informed consent
- Men or women patients ≥40 years of age
- Diagnosis of COPD with symptoms for more than 2 years and there is a history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1-12 months before Visit 2
- Forced Expiratory Volume in 1 second (FEV1) ≤50% of predicted normal value, pre-bronchodilator and Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) < 70%, pre-bronchodilator
- Total symptom score of 2 or more per day for at least half of run-in period (breathing, cough and sputum scores from the diary card) and complete morning recordings of Digital Peak Flow Meter data at least 7 out of the last 10 days of the run-in period
Key exclusion criteria (5 listed)
- A history of asthma and seasonal allergic rhinitis before 40 years of age
- Patients who have experienced exacerbation of COPD requiring hospitalisation and /or emergency room treatment and/or a course of oral steroids and/or intravenous corticosteroids and/or antibiotics within 4 weeks prior to Visit 2 and/or during run-in period and also the patients who use of systemic glucocorticosteroids (GCS) within 4 weeks and/or inhaled GCS within 2 weeks prior to Visit 2 and/or during run-in period
- Patients with relevant cardiovascular disorder judged by the investigator
- Patients with glaucoma, prostatic hyperplasia or bladder-neck obstruction judged by the investigator
- Women who are pregnant, breast-feeding or of child-bearing potential judged by the investigator
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® Turbuhaler®)Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily | Drug | 1 |
| Tiotropium (SpirivaTM)Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily | Drug | 1, 2 |
Primary outcome
Pre-dose FEV1
Time frame: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug
Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value
23 secondary outcomes
Post-dose FEV1 at 5 Minutes
Time frame: Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug
Post-dose FEV1 at 60 Minutes
Time frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)
Pre-dose FVC
Time frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)
Post-dose FVC at 5 Minutes
Time frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12)
Post-dose FVC at 60 Minutes
Time frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)
Pre-dose IC
Time frame: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug
Post-dose IC at 60 Minutes
Time frame: Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)
Pre-dose PEF in Last Week of Treatment
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment, up to 12 weeks
Pre-dose PEF in First Week of Treatment
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the first week of treatment
Pre-dose PEF in Whole Treatment Period
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period of 12 weeks
Post-dose PEF in Last Week of Treatment
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment, up to 12 weeks
Post-dose PEF in First Week of Treatment
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the first week of treatment
Post-dose PEF in Whole Treatment Period
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period of 12 weeks
Use of Reliever Medication During Day in the Last Week on Treatment
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks
Use of Reliever Medication During Day in the First Week on Treatment
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment
Use of Reliever Medication During Day in the Whole Treatment Period
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks
Use of Reliever Medication During Night in the Last Week on Treatment
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks
Use of Reliever Medication During Night in the First Week on Treatment
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment
Use of Reliever Medication During Night in the Whole Treatment Period
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks
Change in COPD Symptoms - Breathing
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks
Change in COPD Symptoms - Cough
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks
Change in COPD Symptoms - Sputum
Time frame: Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks
COPD Exacerbations
Time frame: Whole treatment period of 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26394882Lee SD, Xie CM, Yunus F, Itoh Y, Ling X, Yu WC, Kiatboonsri S. Efficacy and tolerability of budesonide/formoterol added to tiotropium compared with tiotropium alone in patients with severe or very severe COPD: A randomized, multicentre study in East Asia. Respirology. 2016 Jan;21(1):119-27. doi: 10.1111/resp.12646. Epub 2015 Sep 23.
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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.
Samuel Chen, M.D. study chair
AstraZeneca Pharmaceutical Co., Ltd., Shanghai, China
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide/formoterol (Symbicort® Turbuhaler®) and Tiotropium (SpirivaTM) in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 31 sites in 5 countries.
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 5 inclusion and 5 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 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Thailand, China, South Korea, Hong Kong, Indonesia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pre-dose FEV1 (time frame: Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug). 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 NCT01397890, 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 2015.