Chronic Obstructive Pulmonary DiseasePhase 3NCT01070784

A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan

A Phase 3 study testing Symbicort Turbuhaler (Budesonide/formoterol) and Drug: any available COPD treatment; investigator to decide in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 17 sites in Japan.

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

The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD. 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?: Symbicort Turbuhaler (Budesonide/formoterol) and Drug: any available COPD treatment; investigator to decide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 328 participants
Where: 17 sitesJapan
Study dates: Jan 2010to Oct 2011
Phase: Phase 3
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

A current clinical diagnosis of COPD according to the guidelines (GOLD, JPS)
Documented COPD symptoms for more than 2 years
Pre-bronchodilator FEV1≦50% of predicted normal value, and post-bronchodilator FEV1/FVC<70%

Who cannot join

History and/or current clinical diagnosis of asthma and atopic diseases such as allergic rhinitis
Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
COPD exacerbation during the run-in period or within 4 weeks prior to registration, requiring hospitalization and/or treatment with systemic steroids.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

Japan17 sites

Research Site
Asahikawa, Hokkaido
Research Site
Chūō, Tokyo
Research Site
Fujisawa, Kanagawa
Research Site
Hiroshima, Hiroshima
Research Site
Hitachi, Ibaraki
Research Site
Itami, Hyōgo
Research Site
Kōshi, Kumamoto
Research Site
Kyoto, Kyoto
Research Site
Murata, Miyagi
Research Site
Nagoya, Aichi-ken
Research Site
Sakaidechō, Kagawa-ken
Research Site
Sapporo, Hokkaido
Research Site
Setagaya City, Tokyo
Research Site
Toyota, Aichi-ken
Research Site
Tsukuba, Ibaraki
Research Site
Yanagawa, Fukuoka
Research Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: An Open-label Phase III, Multi-centre 52-week , Parallel-group Study Evaluating the Safety and Efficacy of Symbicort Turbuhaler 320/9 Twice Daily Compared With Standard Treatment in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Symbicort Turbuhaler (Budesonide/formoterol), Drug: any available COPD treatment; investigator to decide
Keywords: Symbicort, Safety, Efficacy, COPD, Japanese
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.

Symbicort Turbuhaler (Budesonide/formoterol)Drug
Also called Symbicort Turbuhaler
2 x 160/4.5 microgram, inhalation, bid, 52 weeks
Drug: any available COPD treatment; investigator to decideDrug
According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision

Study groups in NCT01070784
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Symbicort Turbuhaler (Budesonide/formoterol)
2	Active comparator	Not described Receives: Drug: Drug: any available COPD treatment; investigator to decide

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Laboratory Test: Haematology -Erythrocytes
Mean change from Baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Haematology -Haemoglobin
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Haematology -Leucocytes
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Haematology -Platelet Count
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Haematology -Eosinophils
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Haematology -Basophils
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Haematology -Lymphocytes
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Haematology -Monocytes
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Haematology -Neutrophils
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Creatinine
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Sodium
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Potassium
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S- Calcium
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Albumin
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein
Change from baseline
Measured: Baseline and 52 week after
Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen
Change from baseline
Measured: Baseline and 52 week after
Vital Signs- Sitting Systolic Blood Pressure(SBP)
Change from baseline
Measured: Baseline and 52 week after
Vital Signs- Sitting Diastolic Blood Pressure(DBP)
Change from baseline
Measured: Baseline and 52 week after
Vital Signs- Pulse Rate
Change from baseline
Measured: Baseline and 52 week after
ECG Variables - Heart Rate
Change from baseline
Measured: Baseline and 52 week after
ECG Variables - QT Interval
Change from baseline
Measured: Baseline and 52 week after
ECG Variables - QTcB Interval
Change from baseline
Measured: Baseline and 52 week after
ECG Variables - QTcF Interval
Change from baseline
Measured: Baseline and 52 week after
ECG Variables - RR Interval
Change from baseline
Measured: Baseline and 52 week after

Secondary outcomes (13)

Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening
There are 5 alternatives (scored 0 to 4, 0= no awakening and 4 =did not sleep at all). The change from Run-in period average to Treatment period average for each treatment group
Measured: Daily during run-in period and daily during 52-week randomization treatment
Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness
There are 5 alternatives (scored 0 to 4, 0= unaware of any difficulty and 4 =almost constant, present even when resting). The change from Run-in period average to Treatment period average for each treatment group
Measured: Daily during run-in period and daily during 52-week randomization treatment
Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough
There are 5 alternatives (scored 0 to 4, 0= unaware of coughing, 4= never free of cough or need to cough). The change from Run-in period average to Treatment period average for each treatment group
Measured: Daily during run-in period and daily during 52-week randomization treatment
Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic
The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.
Measured: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic
The ratio of the average value of available data for Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group. Ratio is being reported as a percentage in this Measure.
Measured: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Time to First COPD Exacerbation
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. The percentage of participants who had experienced COPD exacerbation at the end of the study for each treatment group.
Measured: Daily during 52-week randomization treatment
Number of COPD Exacerbations Over the Study Treatment Period
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as worsening in COPD symptoms requiring treatment with either a course of systemic steroid or hospitalisation. Number of COPD exacerbation during 52-week randomization treatment
Measured: Daily during 52-week randomization treatment
Rescue Medication Use
The change from run-in period and daily during 52-week randomization treatment
Measured: Daily during 52-week randomization treatment
Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ)
The change from run-in period and daily during 52-week randomization treatment average for each treatment group. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
Measured: Daily during run-in period and daily 52-week randomization treatment
Morning Peak Expiratory Flow (PEF) Measured at Home
The change from Run-in period average to 52-week randomization Treatment period average for each treatment group
Measured: Daily during run-in period and daily 52-week randomization treatment
Evening Peak Expiratory Flow (PEF) Measured at Home
The change from Run-in period average to 52-week randomization Treatment period average for each treatment group
Measured: Daily during run-in period and daily 52-week randomization treatment
Morning FEV1 Measured by the Subjects at Home
The change from run-in period and daily during 52-week randomization treatment
Measured: Daily during run-in period and daily 52-week randomization treatment
Evening FEV1 Measured by the Subjects at Home
The change from run-in period and daily during 52-week randomization treatment
Measured: Daily during run-in period and daily 52-week randomization treatment

Timeline

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

Jan 2010Oct 2011

First posted18 Feb 2010 (estimated)
Study startJan 2010
Primary completionOct 2011
Study completionOct 2011

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 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: None (open label)
Enrolment: 328 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01070784
Sponsor's protocol ID: D589DC00008
Status last verified: Apr 2014
First submitted: 11 Feb 2010
Last updated: 29 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Phase III, Multi-centre 52-week , Parallel-group Study Evaluating the Safety and Efficacy of Symbicort Turbuhaler 320/9 Twice Daily Compared With Standard Treatment in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01070784
Acronym / sponsor ID: D589DC00008
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Symbicort, Safety, Efficacy, COPD, Japanese
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 328 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 18 Feb 2010 (estimated)
Results: Posted 5 Dec 2013

Clinical summary

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

The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Symbicort Turbuhaler (Budesonide/formoterol)
2	Active comparator	Drug: Drug: any available COPD treatment; investigator to decide

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

A current clinical diagnosis of COPD according to the guidelines (GOLD, JPS)
Documented COPD symptoms for more than 2 years
Pre-bronchodilator FEV1≦50% of predicted normal value, and post-bronchodilator FEV1/FVC<70%

Key exclusion criteria (3 listed)

History and/or current clinical diagnosis of asthma and atopic diseases such as allergic rhinitis
Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
COPD exacerbation during the run-in period or within 4 weeks prior to registration, requiring hospitalization and/or treatment with systemic steroids.

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
Symbicort Turbuhaler (Budesonide/formoterol)Also: Symbicort Turbuhaler2 x 160/4.5 microgram, inhalation, bid, 52 weeks	Drug	1
Drug: any available COPD treatment; investigator to decideAccording to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision	Drug	2

Primary outcome

Clinical Laboratory Test: Haematology -Erythrocytes
Time frame: Baseline and 52 week after
Mean change from Baseline
Clinical Laboratory Test: Haematology -Haemoglobin
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Leucocytes
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Platelet Count
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Eosinophils
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Basophils
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Lymphocytes
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Monocytes
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Haematology -Neutrophils
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Aspartate Aminotransferase
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Alkaline Phosphatase (ALP)
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Creatinine
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Total Bilirubin
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Sodium
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Potassium
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S- Calcium
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Albumin
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Protein, Total
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-C-Reactive Protein
Time frame: Baseline and 52 week after
Change from baseline
Clinical Laboratory Test: Clinical Chemistry- S-Urea Nitrogen
Time frame: Baseline and 52 week after
Change from baseline
Vital Signs- Sitting Systolic Blood Pressure(SBP)
Time frame: Baseline and 52 week after
Change from baseline
Vital Signs- Sitting Diastolic Blood Pressure(DBP)
Time frame: Baseline and 52 week after
Change from baseline
Vital Signs- Pulse Rate
Time frame: Baseline and 52 week after
Change from baseline
ECG Variables - Heart Rate
Time frame: Baseline and 52 week after
Change from baseline
ECG Variables - QT Interval
Time frame: Baseline and 52 week after
Change from baseline
ECG Variables - QTcB Interval
Time frame: Baseline and 52 week after
Change from baseline
ECG Variables - QTcF Interval
Time frame: Baseline and 52 week after
Change from baseline
ECG Variables - RR Interval
Time frame: Baseline and 52 week after
Change from baseline

13 secondary outcomes

Chronic Obstructive Pulmonary Disease (COPD) symptoms_Night-time Awakening
Time frame: Daily during run-in period and daily during 52-week randomization treatment
Chronic Obstructive Pulmonary Disease (COPD) symptoms_Breathlessness
Time frame: Daily during run-in period and daily during 52-week randomization treatment
Chronic Obstructive Pulmonary Disease (COPD) symptoms_cough
Time frame: Daily during run-in period and daily during 52-week randomization treatment
Forced Expiratory Volume in 1 Second (FEV1) Measured With the Spirometer at the Clinic
Time frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Forced Vital Capacity (FVC) Measured With the Spirometer at the Clinic
Time frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Time to First COPD Exacerbation
Time frame: Daily during 52-week randomization treatment
Number of COPD Exacerbations Over the Study Treatment Period
Time frame: Daily during 52-week randomization treatment
Rescue Medication Use
Time frame: Daily during 52-week randomization treatment
Health Related Quality of Life (HRQL) Based on the St. George's Respiratory Questionnaire (SGRQ)
Time frame: Daily during run-in period and daily 52-week randomization treatment
Morning Peak Expiratory Flow (PEF) Measured at Home
Time frame: Daily during run-in period and daily 52-week randomization treatment
Evening Peak Expiratory Flow (PEF) Measured at Home
Time frame: Daily during run-in period and daily 52-week randomization treatment
Morning FEV1 Measured by the Subjects at Home
Time frame: Daily during run-in period and daily 52-week randomization treatment
Evening FEV1 Measured by the Subjects at Home
Time frame: Daily during run-in period and daily 52-week randomization treatment

Results and safety

Results posted to the registry on 5 Dec 2013, 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	130	110
COPD Standard Therapy	130	112

Primary outcome: Clinical Laboratory Test: Haematology -Erythrocytes

Time frame: Baseline and 52 week after. Mean (Standard Deviation). Unit: *10000/μl

Measure	Arm 1 - Symbicort Turbuhaler n = 124	Arm 2 - COPD Standard Therapy n = 120
Value	-7.6 (23.9)	-0.1 (22.9)

Primary outcome: Clinical Laboratory Test: Haematology -Haemoglobin

Time frame: Baseline and 52 week after. Mean (Standard Deviation). Unit: g/dL

Measure	Arm 1 - Symbicort Turbuhaler n = 124	Arm 2 - COPD Standard Therapy n = 120
Value	-0.22 (0.74)	-0.05 (0.75)

Primary outcome: Clinical Laboratory Test: Haematology -Leucocytes

Time frame: Baseline and 52 week after. Mean (Standard Deviation). Unit: /microliter(mcl)

Measure	Arm 1 - Symbicort Turbuhaler n = 123	Arm 2 - COPD Standard Therapy n = 120
Value	160.8 (1704.0)	-184.8 (1238.2)

Primary outcome: Clinical Laboratory Test: Haematology -Platelet Count

Time frame: Baseline and 52 week after. Mean (Standard Deviation). Unit: *10000/μl

Measure	Arm 1 - Symbicort Turbuhaler n = 120	Arm 2 - COPD Standard Therapy n = 117
Value	0.86 (3.03)	0.12 (4.04)

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symbicort Turbuhaler	25 of 130 (19.2%)	75 of 130 (57.7%)	Not reported
COPD Standard Therapy	34 of 130 (26.2%)	72 of 130 (55.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Chronic Obstructive Pulmonary Disease

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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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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.

Tomas Andersson, MD study chair

AstraZeneca, R&D, Lund, Sweden

17 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 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 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 5 Dec 2013). 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?

Clinical Laboratory Test: Haematology -Erythrocytes (time frame: Baseline and 52 week after). The study lists 29 primary outcomes in all. 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 NCT01070784.

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 29 Apr 2014.