Chronic Obstructive Pulmonary DiseasePhase 3NCT01047553

Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients

A Phase 3 study testing Formoterol (OT) in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 27 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

This study is a multicentre, open, randomised, parallel-group study with formoterol 9 μg one inhalation b.i.d, or standard COPD therapy. Standard (reference) COPD treatment arm should be the group to refer to when safety results of formoterol arm will be evaluated. 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?: Formoterol (OT)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 251 participants
Where: 27 sitesJapan
Study dates: Dec 2009to Jul 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

Outpatients, men or women ≥ 40 years
A clinical diagnosis of COPD according to guidelines, and current COPD symptoms.
Post-bronchodilator FEV1 < 80% of predicted normal value and FEV1/FVC < 70%, post-bronchodilator

Who cannot join

A history and/or current clinical diagnosis of asthma and atopic diseases such as Allergic rhinitis
Patients who have experienced COPD exacerbation requiring at least one of the following treatment, hospitalisation and/or a course of systemic steroid within 4 weeks prior to the study start.
Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

Japan27 sites

Research Site
Akita, Akita
Research Site
Ako, Hyōgo
Research Site
Bunkyo, Tokyo
Research Site
Chitose, Hokkaido
Research Site
Chūō, Tokyo
Research Site
Fujisawa, Kanagawa
Research Site
Fukuoka, Fukuoka
Research Site
Hitachi, Ibaraki
Research Site
Kanazawa, Ishikawa-ken
Research Site
Katsushika-ku, Tokyo
Research Site
Kawasaki-shi, Kanagawa
Research Site
Kobe, Hyōgo
Research Site
Kodaira, Tokyo
Research Site
Kōshi, Kumamoto
Research Site
Kyoto, Kyoto
Research Site
Matsue, Shimane
Research Site
Moriguchi, Osaka
Research Site
Nagaoka, Niigata
Research Site
Nagoya, Aichi-ken
Research Site
Obihiro, Hokkaido
Research Site
Saiki-shi, Oita Prefecture
Research Site
Sakaidechō, Kagawa-ken
Research Site
Sapporo, Hokkaido
Research Site
Setagaya City, Tokyo
Research Site
Tosima-ku, Tokyo
Research Site
Tsukuba, Ibaraki
Research Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: An Open Phase III, Multi-centre 52-week, Parallel-group Study Evaluating the Safety and Efficacy of Formoterol 18 μg Daily Dose Compared With Standard COPD Treatment, in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Formoterol (OT)
Keywords: Chronic Obstructive Pulmonary Disease, COPD, Japanese, Phase 3, Safety, OT, Oxis
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.

Formoterol (OT)Drug
Also called Oxis Turbuhaler®
9 μg/dose, Inhaled, twice daily for 52 weeks

Study groups in NCT01047553
Study group	Role	What they receive
1	Experimental	Formoterol 9 μg/dose Receives: Drug: Formoterol (OT)

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

Secondary outcomes (11)

Forced Expiratory Volume in One Second (FEV1)
The ratio of the average value of available data for mean from Weeks 0, 4, 8, 17, 26, 34, 43 and 52 to the baseline for each treatment group
Measured: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Forced Vital Capacity (FVC)
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
Measured: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Morning Peak Expiratory Flow(PEF)
The change from Run-in period average to Treatment period average for each treatment group
Measured: Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment
Evening Peak Expiratory Flow (PEF)
The change from Run-in period average to Treatment period average for each treatment group
Measured: Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment
Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Measured: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
Daytime Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Measured: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
Daytime Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
There are 5 alternatives (scored 0 to 4, with 4 being the most severe condition). The change from Run-in period average to Treatment period average for each treatment group
Measured: Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment
Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score
The Total COPD Symptom score is the sum of the measures night-time awakening, breathlessness and cough, ranges from 0 to 12 with 12 being the most severe. The change from Run-in period average to Treatment period average for each treatment group.
Measured: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
Number of COPD Exacerbations Over the 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 was presented here.
Measured: Daily during 52-week randomization treatment
Use of SABA (Salbutamol) as Reliever Medication
The change from Run-in period average to Treatment period average for each treatment group.
Measured: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
St George's Respiratory Questionnaire (SGRQ) Total Score
SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health). The change from Run-in period average to Treatment period average for each treatment group
Measured: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 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.

Dec 2009Jul 2011

First posted13 Jan 2010 (estimated)
Study startDec 2009
Primary completionJan 2011
Study completionJul 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: 251 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01047553
Sponsor's protocol ID: D5122C00002
Status last verified: Dec 2012
First submitted: 12 Jan 2010
Last updated: 4 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Phase III, Multi-centre 52-week, Parallel-group Study Evaluating the Safety and Efficacy of Formoterol 18 μg Daily Dose Compared With Standard COPD Treatment, in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01047553
Acronym / sponsor ID: D5122C00002
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease, COPD, Japanese, Phase 3, Safety, OT, Oxis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 251 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Jan 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 13 Jan 2010 (estimated)
Results: Posted 4 Jan 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Formoterol (OT)Formoterol 9 μg/dose

Who may qualify

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

Key inclusion criteria (3 listed)

Outpatients, men or women ≥ 40 years
A clinical diagnosis of COPD according to guidelines, and current COPD symptoms.
Post-bronchodilator FEV1 < 80% of predicted normal value and FEV1/FVC < 70%, post-bronchodilator

Key exclusion criteria (3 listed)

A history and/or current clinical diagnosis of asthma and atopic diseases such as Allergic rhinitis
Patients who have experienced COPD exacerbation requiring at least one of the following treatment, hospitalisation and/or a course of systemic steroid within 4 weeks prior to the study start.
Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as 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
Formoterol (OT)Also: Oxis Turbuhaler®9 μg/dose, Inhaled, twice daily for 52 weeks	Drug	1

Primary outcome

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

11 secondary outcomes

Forced Expiratory Volume in One Second (FEV1)
Time frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Forced Vital Capacity (FVC)
Time frame: Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Morning Peak Expiratory Flow(PEF)
Time frame: Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment
Evening Peak Expiratory Flow (PEF)
Time frame: Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment
Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Time frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
Daytime Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Time frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
Daytime Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Time frame: Daily during run-in period (14 - 18 days before Randomisation visit) and daily during 52-week randomization treatment
Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score
Time frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
Number of COPD Exacerbations Over the Treatment Period
Time frame: Daily during 52-week randomization treatment
Use of SABA (Salbutamol) as Reliever Medication
Time frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment
St George's Respiratory Questionnaire (SGRQ) Total Score
Time frame: Daily during run-in period (14 - 18 days before Randomisation visit ) and daily during 52-week randomization treatment

Results and safety

Results posted to the registry on 4 Jan 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
Formoterol	125	108
Standard Treatment	126	117

Primary outcome: Clinical Laboratory Test: Haematology -Erythrocytes

Time frame: Baseline and week 52. Mean (Standard Deviation). Unit: erythrocytes counts x10000/μl

Measure	Arm 1 - Formoterol n = 125	Arm 2 - Standard Treatment n = 126
Value	-6.25 (23.8)	-5.2 (27.5)

Population analysed: All randomised subjects who received at least one dose of formoterol or standard COPD treatment for each treatment group respectively and for whom any safety data after randomisation were available were included in the safety population.

Primary outcome: Clinical Laboratory Test: Haematology -Haemoglobin

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

Measure	Arm 1 - Formoterol n = 125	Arm 2 - Standard Treatment n = 126
Value	-0.29 (0.73)	-0.20 (1.14)

Primary outcome: Clinical Laboratory Test: Haematology-Leucocytes

Time frame: Baseline and week 52. Mean (Standard Deviation). Unit: leukocyte count/µL

Measure	Arm 1 - Formoterol n = 125	Arm 2 - Standard Treatment n = 126
Value	-132.1 (1535.3)	-289.5 (1284.6)

Primary outcome: Clinical Laboratory Test: Haematology-Platelet Count

Time frame: Baseline and week 52. Mean (Standard Deviation). Unit: Platelet Count x10000/μl

Measure	Arm 1 - Formoterol n = 125	Arm 2 - Standard Treatment n = 126
Value	0.17 (3.29)	-0.40 (4.06)

11 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
Formoterol	20 of 125 (16%)	54 of 125 (43.2%)	Not reported
Standard Treatment	18 of 126 (14.3%)	60 of 126 (47.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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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.

The record lists no contact. Use the official record to reach the sponsor.

27 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 Formoterol (OT) in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 27 sites in Japan.

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 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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 4 Jan 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 week 52). The study lists 28 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 NCT01047553.

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 4 Jan 2013.