AsthmaPhase 2/3NCT01472757

Clinical Study to Evaluate the Efficacy of VR506 Using a New Inhaler for the Treatment of Asthma

A Phase 2/3 study testing VR506 in people with Asthma, run by Vectura Limited at 82 sites in 5 countries.

Completed

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

Trial summary

The purpose of the study is to evaluate the clinical efficacy of three doses of VR506 delivered via a new dry powder inhaler for the treatment of asthma. Read more about this study

Who is it for?: Ages 12 to 65 years
Conditions the study is for: Asthma
What is being tested?: VR506
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 374 participants
Where: 82 sitesin 5 countries
Study dates: Oct 2011to May 2013
Phase: Phase 2/3
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 12 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Written informed consent
Adolescents aged 12 to 17 years (inclusive) and adults aged 18 to 65 years (inclusive)
Documented clinical history of asthma (i.e. made by a physician) for at least 6 months before the Screening Visit
Documented asthma reversibility in the 5 years prior to or during Screening, or if the asthma reversibility criterion is not met at Screening, then a repeat test may be carried out at the end of the Run-In Period
Subjects with asthma who, in the opinion of the investigator, require maintenance therapy with inhaled corticosteroids (ICS), are believed to have been regularly compliant with this therapy, and are therefore likely to deteriorate within 6 weeks following withdrawal of their usual ICS treatment
Mild or moderate asthma, defined as:

Show all 20Show fewer

Mild - good asthma control achieved by low-dose inhaled corticosteroid (daily dose 200-500 μg beclomethasone dipropionate or equivalent) with or without other low-intensity treatment (e.g. leukotriene modifiers or cromones) for at least 28 days before the Screening Visit
Moderate - good asthma control achieved by low- to moderate-dose ICS (daily dose 200-1000 μg beclomethasone dipropionate or equivalent), and long acting β2-agonist (LABA) or other extra treatment, for at least 28 days before the Screening Visit
Ability to use the new inhaler correctly, based on investigator's review of the completed inhaler operation checklist
Ability to use the eDiary correctly, assessed by the investigator during the Screening Period
Ability to perform technically satisfactory pulmonary function tests
Ability to comply with study procedures, including blood sampling
Body mass index (BMI) of 16.0 to 26.0 kg/m2 in adolescents, and in adult subjects recruited in the Philippines, and 18.0 to 32.0 kg/m2 in adults recruited in other countries
Available to complete all study visits
Oral peak inspiratory flow (PIF) of at least 60 L/min; using an appropriate device set to match the resistance of the new dry powder inhaler (nDPI)
Good health, except for the presence of asthma, according to medical history and physical examination
Normal (i.e. non-clinically significant abnormality) 12-lead electrocardiogram (ECG)
Negative drug, alcohol, and urine cotinine screen; subjects must test negative for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine (unless related to nicotine-containing therapies), ethanol, and opiates (unless given as a prescription medicine)
Non-smokers or ex-smokers with a smoking history of less than 10 pack-years (e.g. <20 cigarettes per day for 10 years or 40 cigarettes per day for 5 years) and stopped smoking for at least one year prior to the Screening Visit. Smoking will not be permitted throughout the study
Female subjects of child-bearing potential must be using medically acceptable forms of contraception; approved forms of contraception are abstinence, hormonal (oral, implant, transdermal, or injection, in use for ≥3 consecutive months before the start of the Run-In Period), double barrier (condom with spermicide, diaphragm with spermicide), intrauterine device, or vasectomised partner (≥6 months since vasectomy)

Who cannot join

Regular use (≥3 times per week) of topical steroids taken to treat dermatitis, rhinitis or allergic conjunctivitis, within 28 days of the Screening Visit
Subjects who have or who have had an upper or lower respiratory tract infection within 28 days of the Screening Visit
Subjects with asthma that required admission to an intensive care unit and/or ventilation within the previous 12 months
History of lung cancer
Subjects with "brittle asthma", defined as patients with asthma who either maintain over many months a wide variation (>40%) in peak expiratory flow (PEF) between morning and evening measurements despite moderate to high doses of ICS, or are prone to acute, severe and often unpredictable attacks of asthma that may be fatal, on a background of apparently good asthma control
History or current diagnosis of human immunodeficiency virus (HIV) infection

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Active chronic hepatitis B or C infection. If the patient's screening test is positive for hepatitis B surface antigen, the patient should be excluded unless the investigator, after a careful review of the patient's medical history and current laboratory tests of liver function, can exclude the possibility of recent or current infection
Persistent arterial hypotension, with average systolic blood pressure (SBP) readings of ≤95 mmHg
Subjects who have any clinically significant abnormality or finding from examination, tests, or history that may compromise subject safety, specifically any history of cardiac, renal or hepatic impairment
Subjects with an abnormal ECG
Persistent elevation of blood pressure, with average SBP readings of ≥160 mmHg or average diastolic blood pressure (DBP) readings of ≥100 mmHg
Pregnant or lactating females
Participation in another clinical study in the 28 days prior to the Screening Visit
Current or a history of drug or alcohol abuse or dependence according to World Health Organization criteria in the 12 months prior to the Screening Visit or evidence of such abuse as indicated by laboratory assays conducted during the screening evaluation
Evidence of clinically significant renal, hepatic, cardiac, pulmonary (apart from asthma) or metabolic dysfunction, e.g. diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia, or predisposition to low levels of serum potassium
Inability to communicate well with the investigator
Evidence of clinically significant renal, hepatic, cardiac, pulmonary (apart from asthma) or metabolic dysfunction, e.g. diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia, or predisposition to low levels of serum potassium
Donation of ≥450 mL of blood or blood products within the previous 12 weeks prior to the Screening Visit
History of allergy, intolerance or contraindications to corticosteroids, lactose, or severe allergy to milk proteins
Consumption of alcohol- or caffeine-containing foods or beverages from midnight before or during the Screening Visit. The visit can be rescheduled once before the subject is excluded
History of medically diagnosed chronic respiratory diseases (other than asthma) e.g. chronic obstructive pulmonary disease
Subjects with previously clinically or radiologically diagnosed osteoporosis and/or those receiving regular treatment (more than 1 month duration) with oral or parenteral corticosteroids in the last year prior to the Screening Visit

Trial locations and contacts

82 sites in 5 countries.

Country

City, postcode or hospital

82 sites in 5 countries

United States32 sites

Vectura Clinical Trial Site 10011
Albany, Georgia, 31707
Vectura Clinical Trial Site 10042
Baltimore, Maryland, 21236
Vectura Clinical Trial Site 10034
Bellevue, Nebraska, 68123
Vectura Clinical Trial Site 10019
Boerne, Texas, 78006
Vectura Clinical Trial Site 10023
Centennial, Colorado, 80112
Vectura Clinical Trial Site 10003
Charleston, South Carolina, 29407
Vectura Clinical Trial Site 10001
Colorado Springs, Colorado, 80907
Vectura Clinical Trial Site 10025
Denver, Colorado, 80230
Vectura Clinical Trial Site 10004
Draper, Utah, 84020
Vectura Clinical Trial Site 10038
Fountain Valley, California, 92708
Vectura Clinical Trial Site 10031
Los Angeles, California, 90048
Vectura Clinical Trial Site 10028
Medford, Oregon, 97504
Vectura Clinical Trial Site 10002
Metairie, Louisiana, 70006
Vectura Clinical Trial Site 10044
Mission Viejo, California, 92691
Vectura Clinical Trial Site 10009
Missoula, Montana, 59808
Vectura Clinical Trial Site 10029
North Dartmouth, Massachusetts, 02747
Vectura Clinical Trial Site 10017
Oklahoma City, Oklahoma, 73103
Vectura Clinical Trial Site 10035
Omaha, Nebraska, 68114
Vectura Clinical Trial Site 10015
Omaha, Nebraska, 68130
Vectura Clinical Trial Site 10022
Orange, California, 92868
Vectura Clinical Trial Site 10008
Plymouth, Minnesota, 55441
Vectura Clinical Trial Site 10024
Portland, Oregon, 97202
Vectura Clinical Trial Site 10014
Rancho Mirage, California, 92270
Vectura Clinical Trial Site 10040
Rochester, New York, 14618
Vectura Clinical Trial Site 10027
Rolling Hills Estates, California, 90274
Vectura Clinical Trial Site 10033
San Jose, California, 95117
Vectura Clinical Trial Site 10041
Sarasota, Florida, 34223
Vectura Clinical Trial Site 10010
Sylvania, Ohio, 43560
Vectura Clinical Trial Site 10021
Upland, Pennsylvania, 19013
Vectura Clinical Trial Site 10016
Vista, California, 90283
Vectura Clinical Trial Site 10039
Waco, Texas, 76712
Vectura Clinical Trial Site 10020
Warrensburg, Missouri, 64093

Other trials in United States

Ukraine17 sites

Vectura Clinical Trial Site 23013
Donetsk, 83099
Vectura Clinical Trial Site 23005
Kharkiv, 61002
Vectura Clinical Trial Site 23004
Kharkiv, 61051
Vectura Clinical Trial Site 23010
Kharkiv, 61124
Vectura Clinical Trial Site 23012
Kiev, 02232
Vectura Clinical Trial Site 23002
Kiev, 03680
Vectura Clinical Trial Site 23009
Kiev, 03680
Vectura Clinical Trial Site 23011
Kiev, 03680
Vectura Clinical Trial Site 23017
Kiev, 03680
Vectura Clinical Trial Site 23001
Kyiv, 04050
Vectura Clinical Trial Site 23003
Kyiv, 04050
Vectura Clinical Trial Site 23018
Kyiv, 04201
Vectura Clinical Trial Site 23007
Odesa, 65031
Vectura Clinical Trial Site 23015
Simferopol, 95034
Vectura Clinical Trial Site 23014
Vinnytsia, 21029
Vectura Clinical Trial Site 23008
Zaporizhzhya, 69063
Vectura Clinical Trial Site 23016
Zaporizhzhya, 69118

Other trials in Ukraine

Poland16 sites

Vectura Clinical Trial Site 20018
Bialystok, 15-430
Vectura Clinical Trial Site 20013
Biołystok, 15-276
Vectura Clinical Trial Site 20015
Krakow, 30-510
Vectura Clinical Trial Site 20019
Krakow, 31-024
Vectura Clinical Trial Site 20009
Lodz, 90-553
Vectura Clinical Trial Site 20007
Łodź, 90-153
Vectura Clinical Trial Site 20012
Lublin, 20-718
Vectura Clinical Trial Site 20008
Ostrów Wielkopolski, 63-400
Vectura Clinical Trial Site 20003
Poznan, 60-214
Vectura Clinical Trial Site 20005
Poznan, 60-823
Vectura Clinical Trial Site 20016
Skiemiewice, 96-100
Vectura Clinical Trial Site 20021
Tarnów, 33-100
Vectura Clinical Trial Site 20010
Warsaw, 04-141
Vectura Clinical Trial Site 20001
Wroclaw, 50-445
Vectura Clinical Trial Site 20006
Wroclaw, 53-301
Vectura Clinical Trial Site 20014
Zawadzkie, 47-120

Other trials in Poland

Romania11 sites

Vectura Clinical Trial Site 21002
Brasov, 500086
Vectura Clinical Trial Site 21011
Bucharest, 050554
Vectura Clinical Trial Site 21004
Cluj-Napoca, 400217
Vectura Clinical Trial Site 21009
Cluj-Napoca, 400371
Vectura Clinical Trial Site 21010
Cluj-Napoca, 400371
Vectura Clinical Trial Site 21007
Iași, 700115
Vectura Clinical Trial Site 21008
Iași, 700870
Vectura Clinical Trial Site 21013
Judetul Cluj, 400371
Vectura Clinical Trial Site 21012
Judetul Iasi, 700115
Vectura Clinical Trial Site 21001
Târgu Mureş, 540141
Vectura Clinical Trial Site 21005
Timișoara, 300689

Other trials in Romania

Philippines6 sites

Vectura Clinical Trial Site 31002
Davao City
Vectura Clinical Trial Site 31003
Iloilo City
Vectura Clinical Trial Site 31001
Lipa City, Batangas
Vectura Clinical Trial Site 31004
Pasig
Vectura Clinical Trial Site 31005
Quezon City
Vectura Clinical Trial Site 31007
Quezon City

Other trials in Philippines

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Study to Evaluate the Efficacy and Safety of VR506 Inhaled From a New Inhaler in Adolescent and Adult Subjects With Asthma

The purpose of the study is to evaluate the clinical efficacy of three doses of VR506 delivered via a new dry powder inhaler for the treatment of asthma.

Conditions: Asthma
Being tested: VR506, Placebo
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VR506Drug
VR506 inhalation powder delivered via a new dry powder inhaler
PlaceboDrug
Placebo delivered via a new dry powder inhaler

Study groups in NCT01472757
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Dose 1	Active comparator	Not described Receives: Drug: VR506
Dose 2	Active comparator	Not described Receives: Drug: VR506
Dose 3	Active comparator	Not described Receives: Drug: VR506

What is being measured

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

Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)
Measured: Baseline and 12 weeks

Secondary outcomes (3)

Number of Participants With Withdrawals Due to Worsening of Asthma
Measured: 12 weeks
Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)
Measured: Baseline and 12 weeks
Assessment of Acceptability of the Device
Percentage of subjects that overall found it very easy, fairly easy or fairy difficult to use the inhaler, based on inhaler acceptability questionnaire.
Measured: 12 weeks

Timeline

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

Oct 2011May 2013

First posted16 Nov 2011 (estimated)
Study startOct 2011
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 374 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01472757
Sponsor's protocol ID: VR506/2/002
Status last verified: Apr 2020
First submitted: 11 Nov 2011
Last updated: 21 Apr 2020
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?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Study to Evaluate the Efficacy and Safety of VR506 Inhaled From a New Inhaler in Adolescent and Adult Subjects With Asthma
ClinicalTrials.gov ID: NCT01472757
Acronym / sponsor ID: VR506/2/002
Conditions: Asthma
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 374 participants (actual)
Lead sponsor: Vectura LimitedIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 16 Nov 2011 (estimated)
Results: Posted 21 Apr 2020

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 the study is to evaluate the clinical efficacy of three doses of VR506 delivered via a new dry powder inhaler for the treatment of asthma.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
Dose 1	Active comparator	Drug: VR506
Dose 2	Active comparator	Drug: VR506
Dose 3	Active comparator	Drug: VR506

Who may qualify

Ages: 12 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (20 listed)

Written informed consent
Adolescents aged 12 to 17 years (inclusive) and adults aged 18 to 65 years (inclusive)
Documented clinical history of asthma (i.e. made by a physician) for at least 6 months before the Screening Visit
Documented asthma reversibility in the 5 years prior to or during Screening, or if the asthma reversibility criterion is not met at Screening, then a repeat test may be carried out at the end of the Run-In Period
Subjects with asthma who, in the opinion of the investigator, require maintenance therapy with inhaled corticosteroids (ICS), are believed to have been regularly compliant with this therapy, and are therefore likely to deteriorate within 6 weeks following withdrawal of their usual ICS treatment

Key exclusion criteria (22 listed)

Regular use (≥3 times per week) of topical steroids taken to treat dermatitis, rhinitis or allergic conjunctivitis, within 28 days of the Screening Visit
Subjects who have or who have had an upper or lower respiratory tract infection within 28 days of the Screening Visit
Subjects with asthma that required admission to an intensive care unit and/or ventilation within the previous 12 months
History of lung cancer
Subjects with "brittle asthma", defined as patients with asthma who either maintain over many months a wide variation (>40%) in peak expiratory flow (PEF) between morning and evening measurements despite moderate to high doses of ICS, or are prone to acute, severe and often unpredictable attacks of asthma that may be fatal, on a background of apparently good asthma control

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
VR506VR506 inhalation powder delivered via a new dry powder inhaler	Drug	Dose 1, Dose 2, Dose 3
PlaceboPlacebo delivered via a new dry powder inhaler	Drug	Placebo

Primary outcome

Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)
Time frame: Baseline and 12 weeks

3 secondary outcomes

Number of Participants With Withdrawals Due to Worsening of Asthma
Time frame: 12 weeks
Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)
Time frame: Baseline and 12 weeks
Assessment of Acceptability of the Device
Time frame: 12 weeks

Results and safety

Results posted to the registry on 21 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	91	61
VR506 50 mcg	93	80
VR506 100 mcg	95	76
VR506 250 mcg	94	75

Primary outcome: Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: Liters

Measure	Placebo n = 90	VR506 50 mcg n = 93	VR506 100 mcg n = 92	VR506 250 mcg n = 91
Value	0.19 (0.36)	0.32 (0.46)	0.38 (0.30)	0.38 (0.33)

Placebo vs VR506 50 mcg: p = 0.013, ANCOVA
Placebo vs VR506 100 mcg: p <0.001, ANCOVA
Placebo vs VR506 250 mcg: p <0.001, ANCOVA

Population analysed: Full analysis set analyzed, but number of patients represents subjects with both start of treatment baseline value and end of treatment value where a Last Observation Carried Forward (LOCF) approach was used to impute values of missing post-baseline visits; 2 subjects had no post-dose FEV1 assessments, baseline values were not carried forward

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 91 (0%)	47 of 91 (51.6%)	0 of 91
VR506 50 mcg	1 of 93 (1.1%)	42 of 93 (45.2%)	0 of 93
VR506 100 mcg	1 of 95 (1.1%)	40 of 95 (42.1%)	0 of 95
VR506 250 mcg	0 of 94 (0%)	33 of 94 (35.1%)	0 of 94

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Asthma

RecruitingPhase 1
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RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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RecruitingPhase 2
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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.

Ronald Dahl, Dr. principal investigator

Aarhus University Hospital

82 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing VR506 in people with Asthma, run by Vectura Limited at 82 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 22 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 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Ukraine, Poland, Romania, Philippines. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 21 Apr 2020). 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?

Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1) (time frame: Baseline and 12 weeks). 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 NCT01472757.

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 21 Apr 2020.