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Pulmonary Disease, Chronic ObstructivePhase 3NCT02207829

A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium Compared With Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease

A Phase 3 study testing Umeclidinium and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 99 sites in 13 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

This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate the efficacy and safety of UMEC inhalation powder[ (62.5 microgram (mcg) once daily (QD)] when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD) administered via a HANDIHALER® inhaler over a… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Umeclidinium and Tiotropium
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,017 participants
Where
99 sitesin 13 countries
Study dates
1 Sep 2014to 15 Jun 2015
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

  • Type of subject: outpatient.
  • Informed Consent: A signed and dated written informed consent prior to study participation.
  • Age: Subjects 40 years of age or older at Visit 1.
  • Gender: Male and female subjects are eligible to participate in the study. A female is eligible to enter and participate in the study if she is of:
  • Non-child bearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, > 45 years, in the absence of hormone replacement therapy. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact). - Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
  • Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g. 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years both equal 10 pack-years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack-year history.
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  • Severity of Disease: A pre and post-albuterol/salbutamol FEV1/ Forced Vital Capacity (FVC) ratio of <0.70 and a post-albuterol/salbutamol FEV1 of >=30% and <=70% of predicted normal values at Visit 1. Predicted values will be based upon the ERS Global Lung Function Initiative
  • Dyspnea: A score of >=2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Visit 1.
  • French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Who cannot join

  • Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study.
  • Asthma: A current diagnosis of asthma.
  • Other Respiratory Disorders: Known Alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease.
  • Other Diseases/Abnormalities: Any subject who is considered unlikely to survive the duration of the study period or has any rapidly progressing disease or immediate life-threatening illness (e.g. cancer). In addition, any subject who has any condition (e.g. neurological condition) that is likely to affect respiratory function should not be included in the study.
  • Severe Hepatic Impairment: Patients with severe hepatic impairment (Child-Pugh class C) should be excluded unless, in the opinion of the investigator, the benefit is likely to outweigh the risk.
  • Moderate to severe Renal Impairment: Patients with moderate to severe renal impairment (e.g., end-stage renal disease requiring dialysis) should be excluded, unless in the opinion of the investigator, the benefit is likely to outweigh the risk.
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  • Unstable or life threatening cardiac disease: Long-acting muscarinic antagonists (LAMAs) should be used with caution in subjects with severe cardiovascular disease. In the opinion of the investigator, use should only be considered if the benefit is likely to outweigh the risk in conditions such as: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association Class IV heart failure
  • Contraindications: Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, sympathomimetic, lactose/milk protein or magnesium stearate.
  • Antimuscarinic effects: Subjects with medical conditions such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction should only be included if, in the opinion of the study physician, the benefit outweighs the risk.
  • Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
  • Lung Resection: Lung volume reduction surgery within the 12 months prior to Visit 1.
  • 12-Lead electrocardiogram (ECG): Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. Subjects with the following abnormalities are excluded from participation in the study: Atrial fibrillation with rapid ventricular rate >120 beats per minute; Sustained or nonsustained ventricular tachycardia; Second degree heart block Mobitz type II or third degree heart block (unless pacemaker or defibrillator had been inserted)
  • Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit.
  • Medications Prior to Screening: Use of the following medications according to the following defined time intervals prior to Visit 1: Depot corticosteroids-12 weeks; Systemic, oral or parenteral corticosteroids- 6 weeks; Antibiotics (for lower respiratory tract infection)- 6 weeks ; long-acting beta2-agonists/inhaled corticosteroids (LABA/ICS) combination products if LABA/ICS therapy is discontinued completely-30 days; LABA/ICS combination products only If discontinuing ICS/LABA therapy and switching to ICS monotherapy- 48 hours for the salmeterol or formoterol component, 14 days for the vilanterol component [The dose of ICS must be a dose of fluticasone propionate (FP) or equivalent but not to exceed 1000 mcg/day] ; Use of ICS at a dose >1000 mcg/day of FP or equivalent- 30 days; Initiation or discontinuation of ICS use-30 days (Use of ICS is permitted provided the dose does not exceed 1000mcg of FP or equivalent; ICS use not to be initiated or discontinued within 30 days prior to Visit 1, except for subjects on LABA/ICS therapy who may discontinue the ICS/LABA product as indicated in the table above and switch to ICS monotherapy); Phosphodiesterase 4 (PDE4) Inhibitor (roflumilast)- 14 days; Inhaled long acting beta2 agonists (LABAs): salmeterol, formoterol-48 hours, olodaterol, indacaterol, vilanterol- 14 days; LAMAs: tiotropium, aclidinium, glycopyrronium, umeclidinium- 7 days; LAMA/LABA combination products if LAMA/LABA therapy is discontinued completely- Apply whichever mono component has the longest washout; Theophyllines- 48 hours; Oral beta2-agonists: Long-acting- 48 hours, Short-acting 12 hours; Inhaled short acting beta2-agonists- 4 hours (Use of study provided albuterol/salbutamol is permitted during the study, except in the 4-hour period prior to spirometry testing) ; Inhaled short-acting anticholinergics- 4 hours; Inhaled short-acting anticholinergic/short-acting beta2-agonist combination products- 4 hours; Any other investigational medication - 30 days or within 5 drug half lives (whichever is longer).
  • Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e. <=12 hours per day) is not exclusionary.
  • Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g. albuterol/salbutamol) via nebulized therapy.
  • Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded.
  • Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.
  • Affiliation with Investigator Site: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study.
  • Inability to read: In the opinion of the investigator, any subject who is unable to read and/or write would not be able to complete a questionnaire

Trial locations and contacts

99 sites in 13 countries.

99 sites in 13 countries

Russia21 sites

  • GSK Investigational Site

    Arkhangelsk, 153000

  • GSK Investigational Site

    Arkhangelsk, 163001

  • GSK Investigational Site

    Barnaul, 656 045

  • GSK Investigational Site

    Irkutsk, 664003

  • GSK Investigational Site

    Izhevsk, 426063

  • GSK Investigational Site

    Kemerovo, 650002

  • GSK Investigational Site

    Moscow, 115 280

  • GSK Investigational Site

    Moscow, 117997

  • GSK Investigational Site

    Novosibirsk, 630102

  • GSK Investigational Site

    Saint Petersburg, 194354

  • GSK Investigational Site

    Saint Petersburg, 194356

  • GSK Investigational Site

    Saint Petersburg, 196084

  • GSK Investigational Site

    Saint Petersburg, 198216

  • GSK Investigational Site

    Saint Petersburg, 198260

  • GSK Investigational Site

    Saint Petersburg

  • GSK Investigational Site

    Sestroretsk, 197706

  • GSK Investigational Site

    Sochi, 354057

  • GSK Investigational Site

    Stavropol, 355017

  • GSK Investigational Site

    Tomsk, 634050

  • GSK Investigational Site

    Ufa, 450071

  • GSK Investigational Site

    Vladimir, 600023

Other trials in Russia

Canada11 sites

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3E 1H5

  • GSK Investigational Site

    Montreal, Quebec, H2R 1V6

  • GSK Investigational Site

    Québec, Quebec, G1V 4G5

  • GSK Investigational Site

    Québec, Quebec, G1W 4R4

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1A 3R5

  • GSK Investigational Site

    Toronto, Ontario, M3J 2C5

  • GSK Investigational Site

    Toronto, Ontario, M5G 1N8

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2

  • GSK Investigational Site

    Winnipeg, Manitoba, R2K 3S8

Other trials in Canada

Germany11 sites

  • GSK Investigational Site

    Aschaffenburg, Bavaria, 63739

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 10717

  • GSK Investigational Site

    Berlin, 13156

  • GSK Investigational Site

    Dresden, Saxony, 01069

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60389

  • GSK Investigational Site

    Neu-Isenburg, Hesse, 63263

  • GSK Investigational Site

    Rodgau, Hesse, 63110

  • GSK Investigational Site

    Schmölln, Thuringia, 04626

  • GSK Investigational Site

    Teuchern, Saxony-Anhalt, 06682

  • GSK Investigational Site

    Wiesbaden, Hesse, 65187

Other trials in Germany

Romania10 sites

  • GSK Investigational Site

    Bacau, 600252

  • GSK Investigational Site

    Brăila, 810003

  • GSK Investigational Site

    Bucharest, 030303

  • GSK Investigational Site

    Codlea, 505100

  • GSK Investigational Site

    Comuna Alexandru Cel Bun, 617507

  • GSK Investigational Site

    Deva, 330084

  • GSK Investigational Site

    Focşani, 620043

  • GSK Investigational Site

    Galati, 800189

  • GSK Investigational Site

    Ploieşti, 100379

  • GSK Investigational Site

    Timișoara, 300310

Other trials in Romania

South Africa10 sites

  • GSK Investigational Site

    Bellville, 7530

  • GSK Investigational Site

    Boksburg, Gauteng, 1459

  • GSK Investigational Site

    Durban, 4001

  • GSK Investigational Site

    Korsten, 6014

  • GSK Investigational Site

    Lynnwood Ridge, Pretoria, 0040

  • GSK Investigational Site

    Mowbray, 7700

  • GSK Investigational Site

    Port Elizabeth, Eastern Cape, 6001

  • GSK Investigational Site

    Somerset West, 7130

  • GSK Investigational Site

    Vrededorp, 2129

  • GSK Investigational Site

    Welkom, 9460

Other trials in South Africa

Ukraine8 sites

  • GSK Investigational Site

    Dnipropetrovsk, 49074

  • GSK Investigational Site

    Kharkiv, 61002

  • GSK Investigational Site

    Kharkiv, 61039

  • GSK Investigational Site

    Kiev, 03680

  • GSK Investigational Site

    Kryvyi Rig, 50096

  • GSK Investigational Site

    Kyiv, 03038

  • GSK Investigational Site

    Poltava, 36038

  • GSK Investigational Site

    Zaporizhzhya, 69050

Other trials in Ukraine

South Korea6 sites

  • GSK Investigational Site

    Bucheon-Si, Gyeonggi-Do, 420-767

  • GSK Investigational Site

    Seoul, 130-709

  • GSK Investigational Site

    Seoul, 134-814

  • GSK Investigational Site

    Seoul, 136-705

  • GSK Investigational Site

    Seoul, 156-707

  • GSK Investigational Site

    Wonju-si, Gangwon-do, 220-701

Other trials in South Korea

Chile5 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7500692

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 7860406

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8360160

  • GSK Investigational Site

    Talcahuano, 4270918

  • GSK Investigational Site

    Valparaíso, Valparaiso, 2341131

Other trials in Chile

France5 sites

  • GSK Investigational Site

    Bletterans, 39140

  • GSK Investigational Site

    Nantes, 44277

  • GSK Investigational Site

    Toulon, 83000

  • GSK Investigational Site

    Tours, 37100

  • GSK Investigational Site

    Vieux-Condé, 59690

Other trials in France

Italy5 sites

  • GSK Investigational Site

    Milan, Lombardy, 20138

  • GSK Investigational Site

    Negrar, Veneto, 37024

  • GSK Investigational Site

    Pisa, Tuscany, 56124

  • GSK Investigational Site

    Riccione (RN), Emilia-Romagna, 47838

  • GSK Investigational Site

    Torrette (AN), The Marches, 60020

Other trials in Italy

Denmark4 sites

  • GSK Investigational Site

    Aarhus C, 8000

  • GSK Investigational Site

    Hvidovre, 2650

  • GSK Investigational Site

    København NV, 2400

  • GSK Investigational Site

    Odense, DK-5000

Other trials in Denmark

Argentina2 sites

  • GSK Investigational Site

    Buenos Aires, C1425BEN

  • GSK Investigational Site

    Buenos Aires, C1426ABP

Other trials in Argentina

United States1 site

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

Other trials in United States

About this study

Official title: A Randomized, Blinded, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg Compared With Tiotropium 18 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate the efficacy and safety of UMEC inhalation powder[ (62.5 microgram (mcg) once daily (QD)] when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD) administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the run-in period, subjects who meet the randomization criteria will be randomized to receive UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in period, randomization at Day 1 (Visit 2), and after randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). For subjects enrolled in Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and Day 168 (Visit 10). The total duration of subject participation in the study will be approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic visit trough forced expiratory volume in one second (FEV1) on treatment Day 85. All subjects will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 7.

HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH \& Co. KG.

Being tested
Umeclidinium, Umeclidinium matching placebo, Tiotropium, Tiotropium matching placebo
Keywords
COPD, inhaler critical errors, double-dummy, novel dry powder inhaler, inhaler preference, tiotropium, umeclidinium, long-acting muscarinic antagonist
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.

  • UmeclidiniumDrug

    Umeclidinium 62.5 mcg once daily in the morning via nDPI

  • Umeclidinium matching placeboDrug

    Umeclidinium matching placebo once daily in the morning via nDPI

  • TiotropiumDrug

    Tiotropium 18 mcg once daily in the morning via HANDIHALER inhaler

  • Tiotropium matching placeboDrug

    Tiotropium matching placebo once daily in the morning via HANDIHALER inhaler

Study groups in NCT02207829
Study groupRoleWhat they receive
Umeclidinium 62.5 mcg + placeboExperimentalSubjects will receive UMEC Inhalation Powder 62.5 mcg once daily via nDPI plus placebo once daily via HANDIHALER inhaler for 12 weeks (24 weeks in Germany). Subjects will be instructed to take one inhalation each morning from both the nDPI and the HANDIHALER inhaler
Receives: Drug: Umeclidinium; Drug: Umeclidinium matching placebo
Tiotropium 18mcg + placeboActive comparatorSubjects will receive Tiotropium 18 mcg once daily via HANDIHALER inhaler plus placebo once daily via nDPI for 12 weeks (24 weeks in Germany). Subjects will be instructed to take one inhalation each morning from both the nDPI and the HANDIHALER inhaler
Receives: Drug: Tiotropium; Drug: Tiotropium matching placebo

What is being measured

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

  1. Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.

    Measured: Baseline (BL) and Day 85

Timeline

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

  1. First posted4 Aug 2014 (estimated)
  2. Study start1 Sep 2014
  3. Primary completion25 May 2015
  4. Study completion15 Jun 2015

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,017 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02207829
Sponsor's protocol ID
201316
Status last verified
Jan 2018
First submitted
31 Jul 2014
Last updated
24 Jan 2018
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Shah D, Driessen M, Risebrough N, Baker T, Naya I, Briggs A, Ismaila AS. Cost-effectiveness of umeclidinium compared with tiotropium and glycopyrronium as monotherapy for chronic obstructive pulmonary disease: a UK perspective. Cost Eff Resour Alloc. 2018 May 10;16:17. doi: 10.1186/s12962-018-0101-3. eCollection 2018.

    PubMed 29773969

  • Feldman G, Maltais F, Khindri S, Vahdati-Bolouri M, Church A, Fahy WA, Trivedi R. A randomized, blinded study to evaluate the efficacy and safety of umeclidinium 62.5 mug compared with tiotropium 18 mug in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016 Apr 7;11:719-30. doi: 10.2147/COPD.S102494. eCollection 2016.

    PubMed 27103795

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Umeclidinium and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 99 sites in 13 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 9 inclusion and 20 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 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in Russia, Canada, Germany, Romania, South Africa and 8 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 9 Feb 2016). 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?

Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (time frame: Baseline (BL) and Day 85). 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 NCT02207829, which also lists 2 linked publications.

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 24 Jan 2018.

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