Chronic Obstructive Pulmonary DiseasePhase 3SUMIRENCT01069289

Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients

A Phase 3 study testing Budesonide/formoterol (Symbicort Turbuhaler) and Formoterol (Oxis Turbuhaler) in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 119 sites in 9 countries.

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 primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in 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?: Budesonide/formoterol (Symbicort Turbuhaler) and Formoterol (Oxis Turbuhaler)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,293 participants
Where: 119 sitesin 9 countries
Study dates: Jan 2010to Mar 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 Chronic Obstructive Pulmonary Disease
Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years
A smoking history of at least 10 pack years

Who cannot join

History and/or current clinical diagnosis of asthma
History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis

Trial locations and contacts

119 sites in 9 countries.

Country

City, postcode or hospital

119 sites in 9 countries

Japan62 sites

Research Site
Akita, Akita
Research Site
Asahikawa, Hokkaido
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Chino-shi, Nagano
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Chūō, Tokyo
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Fujisawa, Kanagawa
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Fukuoka, Fukuoka
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Gifu, Gifu
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Himeji, Hyōgo
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Hiroshima, Hiroshima
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Hitachi, Ibaraki
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Isahaya-shi, Nagasaki
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Itami, Hyōgo
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Izumi-shi, Osaka
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Kagoshima, Kagoshima-ken
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Kanazawa, Ishikawa-ken
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Kawasaki-shi, Kanagawa
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Kishiwada, Osaka
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Kitakatsushika-gun, Saitama
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Kobe, Hyōgo
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Kochi, Kochi
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Koshigaya-shi, Saitama
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Kurashiki-shi, Okayama-ken
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Kyoto, Kyoto
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Maebashi, Gunma
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Matsue, Shimane
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Matsumoto, Nagano
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Matsusaka-shi, Mie-ken
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Meguro City, Tokyo
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Minato-ku, Tokyo
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Moriguchi, Osaka
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Murata, Miyagi
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Nagaoka, Niigata
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Nagoya, Aichi-ken
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Naka-gun, Ibaragi
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Obihiro, Hokkaido
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Okayama, Okayama-ken
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Okazaki, Aichi-ken
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Osaka, Osaka
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Ōta, Gunma
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Saga, Saga-ken
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Saiki-shi, Oita Prefecture
Researche Site
Sakai-shi, Osaka
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Sakaidechō, Kagawa-ken
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Sapporo, Hokkaido
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Sendai, Miyagi
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Setagaya City, Tokyo
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Seto, Aichi-ken
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Shinagawa-ku, Tokyo
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Suginami-ku, Tokyo
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Sumida-ku, Tokyo
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tabashi City, Tokyo
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Takayama-shi, Gifu
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Tomakomai, Hokkaido
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Toyota, Aichi-ken
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Toyota-shi, Aichi-ken
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Tsukuba, Ibaraki
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Urasoe-shi, Okinawa
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Wakayama, Wakayama
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Yanagawa, Fukuoka
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Yokohama, Kanagawa
Research Site
Yufu-shi, Oita Prefecture
Research Site
Zama-shi, Kanagawa

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Poland21 sites

Research Site
Bialystok
Research Site
Bydgoszcz
Research Site
Chodzież
Research Site
Jarosław
Research Site
Karpacz
Research Site
Krakow
Research Site
Lodz
Research Site
Loma
Research Site
Lublin
Research Site
Ostrów Wielkopolski
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Piła
Research Site
Poznan
Research Site
Ruda Śląska
Research Site
Słupca
Research Site
Tczew
Research Site
Torun
Research Site
Turek
Research Site
Włoszczowa
Research Site
Zabrze
Research Site
Zawadzkie
Research Site
Żnin

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India7 sites

Research Site
Bangalore, Karnataka
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Coimbatore, Tamil Nadu
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Indore, Madhya Pradesh
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Mysore, Karnataka
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Nagpur, Maharashtra
Research Site
New Delhi, National Capital Territory of Delhi
Research Site
Trivandrum, Kerala

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Russia7 sites

Research Site
Barnaul, Russia
Research Site
Kazan', Russia
Research Site
Moscow, Russia
Research Site
Novosibirsk
Research Site
Saint Petersburg, Russia
Research Site
Vladikavkaz
Research Site
Yekaterinburg, Russia

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Ukraine7 sites

Research Site
Dnipropetrovsk
Research Site
Donetsk
Research Site
Kyiv
Research Site
Poltava
Research Site
Uzhhorod
Research Site
Vinytsa
Research Site
Zaporozye

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Philippines6 sites

Research Site
Davao City, Philippines
Research Site
Iloilo City
Research Site
Lipa City, Batangas
Research Site
Olongapo City
Research Site
Quezon City
Researche Site
San Fernando City, Pampanga

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Taiwan4 sites

Research Site
Chiayi City
Research Site
Kaohsiung City
Research Site
Keelung
Research Site
Taipei

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South Korea3 sites

Research Site
Ansan
Research Site
Incheon
Research Site
Seoul

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Vietnam2 sites

Research Site
Hanoi
Research Site
Ho Chi Minh City, Vietnam

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About this study

Official title: A Phase III, 12-week, Double-blind, Randomised, Parallel-group, Active-controlled, Multinational, Efficacy and Safety Study of Symbicort® Turbuhaler® 160/4.5 μg 2 Inhalations Twice Daily (Bid) Compared to Oxis® Turbuhaler® 4.5 μg 2 Inhalations Twice Daily (Bid) in Patients With Chronic Obstructive Pulmonary Disease

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Budesonide/formoterol (Symbicort Turbuhaler), Formoterol (Oxis Turbuhaler)
Keywords: Symbicort, Oxis, Chronic Obstructive Pulmonary Disease, COPD, Efficacy
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
Also called Symbicort Turbuhaler
2x160/4.5 microgram, inhalation, twice daily, 12 weeks
Formoterol (Oxis Turbuhaler)Drug
Also called Oxis Turbuhaler
2 X 4.5 microgram, inhalation, twice daily, 12 weeks

Study groups in NCT01069289
Study group	Role	What they receive
1	Experimental	Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily Receives: Drug: Budesonide/formoterol (Symbicort Turbuhaler)
2	Active comparator	Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily Receives: Drug: Formoterol (Oxis Turbuhaler)

What is being measured

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

Pre-dose Forced Expiratory Volume in One Second (FEV1)
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Measured: Before randomization, 0, 4, 8 and 12 weeks after randomization

Secondary outcomes (16)

1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Measured: Before randomization, 0, 4, 8 and 12 weeks after randomization
Pre-dose Forced Vital Capacity (FVC)
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Measured: Before randomization, 0, 4, 8 and 12 weeks after randomization
1 Hour Post-dose Forced Vital Capacity (FVC)
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group
Measured: Before randomization, 0, 4, 8 and 12 weeks after randomization
Percentage of Participants With Exacerbations
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 12-week randomization treatment
Number of Chronic Obstructive Pulmonary Disease (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. Number of COPD exacerbation during 12-week randomization treatment
Measured: Daily during 12-week randomization treatment
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 and daily during 12-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 and daily during 12-week randomization treatment
Total Number of Day With Exacerbation
Total number of days with COPD exacerbation for each treatment group
Measured: Daily during 12-week randomization treatment
Morning Forced Expiratory Volume in One Second (FEV1)
The change from Run-in period average to Treatment period average for each treatment group
Measured: Daily during run-in period and daily during 12-week randomization treatment
Evening Forced Expiratory Volume in One Second (FEV1)
The change from Run-in period average to Treatment period average for each treatment group
Measured: Daily during run-in period and daily during 12-week randomization treatment
Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Scored 0 to 1 (0 = no awakening and 1 = awakening). The change from Run-in period average to Treatment period average for each treatment group
Measured: Daily during run-in period and daily during 12-week randomization treatment
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 and daily during 12-week randomization treatment
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 and daily during 12-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 and daily during 12-week randomization treatment
Use of Rescue Medication
The change from Run-in period average to Treatment period average for each treatment group.
Measured: Daily during run-in period and daily during 12-week randomization treatment
St George's Respiratory Questionnaire (SGRQ) Total Score
The change from Run-in period average to Treatment period 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 during 12-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 2010Mar 2011

First posted17 Feb 2010 (estimated)
Study startJan 2010
Primary completionMar 2011
Study completionMar 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,293 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01069289
Sponsor's protocol ID: D589DC00007
Acronym: SUMIRE
Status last verified: Sep 2012
First submitted: 11 Feb 2010
Last updated: 25 Oct 2012
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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Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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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)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, 12-week, Double-blind, Randomised, Parallel-group, Active-controlled, Multinational, Efficacy and Safety Study of Symbicort® Turbuhaler® 160/4.5 μg 2 Inhalations Twice Daily (Bid) Compared to Oxis® Turbuhaler® 4.5 μg 2 Inhalations Twice Daily (Bid) in Patients With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT01069289
Acronym / sponsor ID: SUMIRE / D589DC00007
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Symbicort, Oxis, Chronic Obstructive Pulmonary Disease, COPD, Efficacy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,293 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 17 Feb 2010 (estimated)
Results: Posted 25 Oct 2012

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Budesonide/formoterol (Symbicort Turbuhaler)Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily
2	Active comparator	Drug: Formoterol (Oxis Turbuhaler)Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily

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 Chronic Obstructive Pulmonary Disease
Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years
A smoking history of at least 10 pack years

Key exclusion criteria (2 listed)

History and/or current clinical diagnosis of asthma
History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis

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)Also: Symbicort Turbuhaler2x160/4.5 microgram, inhalation, twice daily, 12 weeks	Drug	1
Formoterol (Oxis Turbuhaler)Also: Oxis Turbuhaler2 X 4.5 microgram, inhalation, twice daily, 12 weeks	Drug	2

Primary outcome

Pre-dose Forced Expiratory Volume in One Second (FEV1)
Time frame: Before randomization, 0, 4, 8 and 12 weeks after randomization
The ratio, expressed as percentage, of the geometric mean of available data for Weeks 0, 4, 8 and 12 to the baseline for each treatment group

16 secondary outcomes

1 Hour Post Dose Forced Expiratory Volume in One Second (FEV1)
Time frame: Before randomization, 0, 4, 8 and 12 weeks after randomization
Pre-dose Forced Vital Capacity (FVC)
Time frame: Before randomization, 0, 4, 8 and 12 weeks after randomization
1 Hour Post-dose Forced Vital Capacity (FVC)
Time frame: Before randomization, 0, 4, 8 and 12 weeks after randomization
Percentage of Participants With Exacerbations
Time frame: Daily during 12-week randomization treatment
Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Time frame: Daily during 12-week randomization treatment
Morning Peak Expiratory Flow(PEF)
Time frame: Daily during run-in period and daily during 12-week randomization treatment
Evening Peak Expiratory Flow (PEF)
Time frame: Daily during run-in period and daily during 12-week randomization treatment
Total Number of Day With Exacerbation
Time frame: Daily during 12-week randomization treatment
Morning Forced Expiratory Volume in One Second (FEV1)
Time frame: Daily during run-in period and daily during 12-week randomization treatment
Evening Forced Expiratory Volume in One Second (FEV1)
Time frame: Daily during run-in period and daily during 12-week randomization treatment
Night-time Awakening Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Time frame: Daily during run-in period and daily during 12-week randomization treatment
Breathlessness Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Time frame: Daily during run-in period and daily during 12-week randomization treatment
Cough Due to Chronic Obstructive Pulmonary Disease (COPD) Symptoms
Time frame: Daily during run-in period and daily during 12-week randomization treatment
Total Chronic Obstructive Pulmonary Disease (COPD) Symptom Score
Time frame: Daily during run-in period and daily during 12-week randomization treatment
Use of Rescue Medication
Time frame: Daily during run-in period and daily during 12-week randomization treatment
St George's Respiratory Questionnaire (SGRQ) Total Score
Time frame: Daily during run-in period and daily during 12-week randomization treatment

Results and safety

Results posted to the registry on 25 Oct 2012, 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 (Experimental)	636	594
Oxis Turbuhaler (Active Comparator)	657	601

Primary outcome: Pre-dose Forced Expiratory Volume in One Second (FEV1)

Time frame: Before randomization, 0, 4, 8 and 12 weeks after randomization. Geometric mean (Full Range). Unit: percentage of Baseline

Measure	Symbicort Turbuhaler (Experimental) n = 618	Oxis Turbuhaler (Active Comparator) n = 635
Value	104.6 (37.4 to 311.1)	101.5 (35.1 to 218.5)

Population analysed: The analysis set for efficacy was based on the Full Analysis Set (FAS). Available data represent patients who had both baseline and on treatment data which is required to be included in the analysis.

16 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symbicort Turbuhaler (Experimental)	43 of 636 (6.8%)	61 of 636 (9.6%)	Not reported
Oxis Turbuhaler (Active Comparator)	45 of 657 (6.8%)	66 of 657 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
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.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
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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RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

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.

Lars-Göran Carlsson, MD study chair

AstraZeneca R&D, Lund, Sweden

Yoshinosuke Fukuchi, M.D., PhD principal investigator

Department of Respiratory medicine, Juntendo University

119 sites in 9 countries: 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 2 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 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in Japan, Poland, India, Russia, Ukraine and 4 more countries. 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 25 Oct 2012). 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 Forced Expiratory Volume in One Second (FEV1) (time frame: Before randomization, 0, 4, 8 and 12 weeks after randomization). 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 NCT01069289.

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 25 Oct 2012.