Chronic Obstructive Pulmonary Disease (COPD)Phase 4SECURE2NCT01415518

Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients

A Phase 4 study testing Drug: Budesonide/formoterol (Symbicort Turbuhaler, Drug: ipratropium (AtroventTM) and theophylline SR in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 21 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients. 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?: Drug: Budesonide/formoterol (Symbicort Turbuhaler, Drug: ipratropium (AtroventTM) and theophylline SR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 581 participants
Where: 21 sitesChina
Study dates: 1 Sep 2011to 1 Dec 2012
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
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

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

China21 sites

Research Site
Beijing, Beijing Municipality
Research Site
Changchun, Jilin
Research Site
Changsha, Hunan
Research Site
Chengdu
Research Site
Chongqin
Research Site
Dalian
Research Site
Foshan, Guangdong
Research Site
Guangzhou, Guangdong
Research Site
Ha'er BING
Research Site
Haikou, Hainan
Research Site
Hohhot
Research Site
Nanjing, Jiangsu
Research Site
Qingdao, Shandong
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang, Liaoning
Research Site
Shijiazhuang, Hebei
Research Site
Tangshan, Hebei
Research Site
Tianjin, Tianjin Municipality
Research Site
Wuhan, Hubei
Research Site
Zhengzhou, Henan
Research Site
Zhongshan, Guangdong

Other trials in China

About this study

Official title: Efficacy and Tolerability Study of Symbicort Turbuhaler(160/4.5µg/Inhalation,2inhalations Twice Daily) Added to Atrovent (20µg/Inhalation, 2 Inhalations 4 Times Daily)+Theophylline SR(0.1g/Tablet,1 Tablet p.o. Twice Daily) Compared With Atrovent+Theophylline SR in Severe COPD Patients.

Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients.

Read the detailed description

Efficacy and tolerability study of Symbicort Turbuhaler (160/4.5µg/inhalation,2inhalations twice daily) added to Atrovent (20µg/inhalation, 2 inhalations 4 times daily) + theophylline SR(0.1g/tablet, 1 tablet p.o. twice daily) compared with Atrovent + theophylline SR in severe COPD patients.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Drug: Budesonide/formoterol (Symbicort Turbuhaler, Drug: ipratropium (AtroventTM), theophylline SR
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.

Drug: Budesonide/formoterol (Symbicort TurbuhalerDrug
budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily)
Drug: ipratropium (AtroventTM)Drug
ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily)
theophylline SRDrug
theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)

Study groups in NCT01415518
Study group	Role	What they receive
1	Other	budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily) Receives: Drug: Drug: Budesonide/formoterol (Symbicort Turbuhaler; Drug: Drug: ipratropium (AtroventTM); Drug: theophylline SR
2	Other	ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily) Receives: Drug: Drug: ipratropium (AtroventTM); Drug: theophylline SR

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 (meaured 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) to baseline
Measured: Baseline (meaured 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
Measured: Baseline (meaured 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
Measured: Baseline (meaured 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) to baseline
Measured: Baseline (meaured 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 IC at 60 Minutes
Ratio of post-dose IC at 60 minutes to baseline
Measured: Baseline (meaured 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
Pre-dose PEF in First Week of Treatment
Change in pre-dose morning PEF 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 measurments 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 (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
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 measurments 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 (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 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
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 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 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 (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 (12 weeks)
COPD Symptoms - Cough
Change in cough symptom score (from 0 (none) to 4 (almost constant)) 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 (12 weeks)
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 (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 (12 weeks)
Use of Reliever Medication During Night in the Last Week on Treatment
Change in the number of inhalations of reliever medication during day from run-in 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 night in the last week on treatment
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 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 day from run-in 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 night in the whole treatment period (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20111 Dec 2012

First posted12 Aug 2011 (estimated)
Study start1 Sep 2011
Primary completion1 Dec 2012
Study completion1 Dec 2012

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.
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: 581 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01415518
Sponsor's protocol ID: D589BL00022
Acronym: SECURE2
Status last verified: Jun 2019
First submitted: 8 Aug 2011
Last updated: 9 Jul 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Tolerability Study of Symbicort Turbuhaler(160/4.5µg/Inhalation,2inhalations Twice Daily) Added to Atrovent (20µg/Inhalation, 2 Inhalations 4 Times Daily)+Theophylline SR(0.1g/Tablet,1 Tablet p.o. Twice Daily) Compared With Atrovent+Theophylline SR in Severe COPD Patients.
ClinicalTrials.gov ID: NCT01415518
Acronym / sponsor ID: SECURE2 / D589BL00022
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Severe chronic obstructive pulmonary disease (COPD) patients
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 581 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 1 Sep 2011 (actual)
Primary completion: 1 Dec 2012 (actual)
Study completion: 1 Dec 2012 (actual)
First posted: 12 Aug 2011 (estimated)
Results: Posted 26 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Efficacy and tolerability study in severe chronic obstructive pulmonary disease (COPD) patients.

Detailed description

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: Drug: Budesonide/formoterol (Symbicort Turbuhaler, Drug: Drug: ipratropium (AtroventTM), Drug: theophylline SRbudesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
2	Other	Drug: Drug: ipratropium (AtroventTM), Drug: theophylline SRipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)

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
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
Drug: Budesonide/formoterol (Symbicort Turbuhalerbudesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily)	Drug	1
Drug: ipratropium (AtroventTM)ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily)	Drug	1, 2
theophylline SRtheophylline SR (0.1g/tablet, 1 tablet p.o. twice 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 (meaured 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 (meaured 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 (meaured 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 (meaured 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 (meaured 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 IC at 60 Minutes
Time frame: Baseline (meaured 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
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 measurments 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 (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
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 measurments 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 (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
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 (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 (12 weeks)
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 (12 weeks)
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 (12 weeks)
COPD Exacerbations
Time frame: Whole treatment period (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 night in the last week on treatment
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 night in the whole treatment period (12 weeks)

Results and safety

Results posted to the registry on 26 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symbicort Turbuhaler + Ipratropium + Theophylline SR	292	276
Ipratropium + Theophylline SR	292	261

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. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	Symbicort Turbuhaler + Ipratropium + Theophylline SR n = 286	Ipratropium + Theophylline SR n = 286
Value	1.079 (1.059 to 1.100)	1.009 (0.990 to 1.029)

Symbicort Turbuhaler + Ipratropium + Theophylline SR vs Ipratropium + Theophylline SR: Ratio: 1.069 (95% CI 1.043 to 1.096), p <.0001, ANCOVA

Population analysed: FAS

23 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symbicort Turbuhaler + Ipratropium + Theophylline SR	9 of 293 (3.1%)	33 of 293 (11.3%)	Not reported
Ipratropium + Theophylline SR	10 of 289 (3.5%)	31 of 289 (10.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Clinical Study ProtocolLink provided by the sponsor.
CSR SynopsisLink provided by the sponsor.

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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 study chair

AstraZeneca Singapore Pte Ltd

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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 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 26 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 NCT01415518.

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 9 Jul 2019.