Smoking Cessation InterventionNCT02539875
Promoting Smoking Cessation in the Community Via QTW 2015
A study testing AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices in people with Smoking Cessation Intervention, run by The University of Hong Kong at 1 site in China.
Trial summary
Although smoking prevalence is decreasing in Hong Kong, there are still 648,800 daily smokers 10.8% (Census and Statistics Department, 2013) and half will be killed by smoking (Lam, 2012) which accounts for over 7,000 deaths per year (Lam, Ho, Hedley, Mak, \& Peto, 2001). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation Intervention
- What is being tested?
- AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,306 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2015to 30 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hong Kong residents aged 18 or above
- Smoke at least 1 cigarette per day in the past 3 months
- Able to communicate in Cantonese
- Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO smokerlyzer
- Have Intention to quit
Who cannot join
- Smokers who have difficulties (either physical or cognitive condition) to communicate
- Currently following other smoking cessation programs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2015: a Randomized Controlled Trial on Brief Intervention (AWARD Model) and Active Referral to Smoking Cessation Services
Although smoking prevalence is decreasing in Hong Kong, there are still 648,800 daily smokers 10.8% (Census and Statistics Department, 2013) and half will be killed by smoking (Lam, 2012) which accounts for over 7,000 deaths per year (Lam, Ho, Hedley, Mak, \& Peto, 2001). Smoking also accounts for a large amount of medical cost, long-term care and productivity loss of US$688 million (0.6% Hong Kong GDP) (Census \& Statistics Department, 2001; McGhee et al., 2006) . Smoking is a highly addictive behavior and it is difficult for smokers with strong nicotine dependence to quit without assistance. On the other hand, reaching and helping the many smokers who have no intention to quit is a challenge, because they are unlikely to seek professional help from smoking cessation services.
The Quit and Win programme provides an opportunity to reach and encourage a large group of smokers to make quit attempt and maintain abstinence. The Quit and Win model posits that smokers participating in the contest will have higher motivation to quit with incentives and better social support (Cahill \& Perera, 2011). Studies have found that such quitting contests or incentive programs appeared to reach a large number of smokers and demonstrated a significantly higher quit rate for the quit and win group than for the control group (Cahill \& Perera, 2008).
Read more
Smoking cessation services in Hong Kong are under-used with more than half (60.9%) adult daily smokers who had never used smoking cessation services (Census and Statistics Department, 2013). Among these smokers only 9.6% were willing to use the services. Existing services mostly require self-initiation to seek the services but smokers general lack the will power of initiation. Active referral will help overcome the barriers of self-initiation. There is preliminary evidence that active referral of smokers to smoking cessation hotline services may increase likelihood of smoking abstinence at 12-month follow-up compared with no active referrals (Borland et al., 2008). A recent study has also reported that individuals who used the community-based referral were also more likely to quit than those who did not (43.6% vs 15.3%, P<0.001) (Haas et al., 2015).
Therefore, the present study will examine (1) effectiveness of the active referral and AWARD approaches, (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.
- Conditions
- Smoking Cessation Intervention
- Being tested
- AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices
- Keywords
- Effectiveness of quit immediately (QI) and cut down to quit (CDTQ) interventions in achieving smoking abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advicesBehavioural
Use AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices interventions to achieve smoking abstinence
| Study group | Role | What they receive |
|---|---|---|
| AWARD, Brief leaflet, Referral leaflet, active referral | Experimental | AWARD will be delivered to smokers onsite and this includes: Ask about smoking history, Warn about the high risk, Advise to quit as soon as possible and not later than a quit date (which will qualify them for the QTW prizes), Refer smokers to smoking cessation services, and Do it again: to repeat the intervention. Brief innovative leaflet on health warning and smoking cessation. A 2-side color printed A4 leaflet will be designed to systematically cover the most important messages to motivate smoking cessation. A 2-side color printed A4 referral leaflet will be used for motivate and assist the smokers to use the smoking cessation services. the smokers will be active refer to various smoking cessation services in Hong Kong (using the referral leaflet) and motivate the smokers to use the smoking cessation services. Receives: Behavioral: AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices |
| AWARD, Brief leaflet | Experimental | AWARD will be delivered to smokers onsite and this includes: Ask about smoking history, Warn about the high risk, Advise to quit as soon as possible and not later than a quit date (which will qualify them for the QTW prizes), Refer smokers to smoking cessation services, and Do it again: to repeat the intervention. Brief innovative leaflet on health warning and smoking cessation. A 2-side color printed A4 leaflet will be designed to systematically cover the most important messages to motivate smoking cessation. Receives: Behavioral: AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices |
| Smoking cessation booklet, general advices | Active comparator | Participants will receive minimal intervention, including: (1) the 12-page smoking cessation booklet (provided by COSH); (2) very brief, minimal and general smoking cessation advice include: "Please quit smoking for improving health and save money", "Please refer to the booklet for the details about smoking cessation" and "Please call us if you have any enquiry". Receives: Behavioral: AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking quit rate change from baseline at 3-month follow-up
The primary outcomes are self-reported 7-day point prevalence (pp) quit rate at 3 and 6 months among the two groups
Measured: 3-month follow-up
smoking quit rate change from baseline at 6-month follow-up
The primary outcomes are self-reported 7-day point prevalence (pp) quit rate
Measured: 6-month follow-up
Secondary outcomes (12)
Biochemical validated quit rate
biochemically validated quit rates at 3 month in the two groups
Measured: 3-month follow-up
Biochemical validated quit rate
biochemically validated quit rates at 6 month in the two groups
Measured: 6-month follow-up
Smoking reduction rate change from baseline at 3-month follow-up
rate of smoking reduction by at least half of baseline amount in the two groups
Measured: 3-month follow-up
Smoking reduction rate change from baseline at 6-month follow-up
rate of smoking reduction by at least half of baseline amount in the two groups
Measured: 6-month follow-up
Smoking quit attempt change from baseline at 3-month follow-up
number of quit attempts at 3 month among the two groups
Measured: 3-month follow-up
Smoking quit attempt change from baseline at 6-month follow-up
number of quit attempts at 6 month among the two groups
Measured: 6-month follow-up
quit rate for all subjects change from baseline at 3-month follow-up
the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2015
Measured: 3-month follow-up
Reduction rate for all subjects change from baseline at 3-month follow-up
the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2015
Measured: 3-month follow-up
quit rate for all subjects change from baseline at 6-month follow-up
the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2015
Measured: 6-month follow-up
Reduction rate for all subjects change from baseline at 6-month follow-up
the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2015
Measured: 6-month follow-up
quit rate for all subjects change from baseline at 12-month follow-up
the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2015
Measured: 12-month follow-up
Reduction rate for all subjects change from baseline at 12-month follow-up
the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2015
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study start1 Jun 2015
- Primary completion30 Apr 2016
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Smoking Cessation InterventionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,306 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Council on Smoking and Health
- Responsible party
- Principal investigator, Dr. Wang Man-Ping, The University of Hong Kong
- Investigators
- Man Ping Kelvin Wang, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539875
- Sponsor's protocol ID
- QTW2015
- Status last verified
- Nov 2016
- First submitted
- 22 Jul 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Zeng Y, Wu YS, Luk TT, Zhao SZ, Guo Z, Li Y, Tong HSC, Lai VWY, Cheung YTD, Lam TH, Wang MP. Quitting trajectories of Hong Kong Chinese smokers receiving behavioral smoking cessation interventions: A post hoc analysis of eight randomized controlled trials. Addiction. 2026 Jun;121(6):1568-1579. doi: 10.1111/add.70328. Epub 2026 Jan 17.
PubMed 41546550Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
PubMed 39868569Wang MP, Suen YN, Li WH, Lam CO, Wu SY, Kwong AC, Lai VW, Chan SS, Lam TH. Intervention With Brief Cessation Advice Plus Active Referral for Proactively Recruited Community Smokers: A Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2017 Dec 1;177(12):1790-1797. doi: 10.1001/jamainternmed.2017.5793.
PubMed 29059277Suen YN, Wang MP, Li WH, Kwong AC, Lai VW, Chan SS, Lam TH. Brief advice and active referral for smoking cessation services among community smokers: a study protocol for randomized controlled trial. BMC Public Health. 2016 May 11;16:387. doi: 10.1186/s12889-016-3084-z.
PubMed 27169630
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2015: a Randomized Controlled Trial on Brief Intervention (AWARD Model) and Active Referral to Smoking Cessation Services
- ClinicalTrials.gov ID
- NCT02539875
- Acronym / sponsor ID
- QTW2015
- Conditions
- Smoking Cessation Intervention
- Keywords
- Effectiveness of quit immediately (QI) and cut down to quit (CDTQ) interventions in achieving smoking abstinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,306 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Council on Smoking and Health
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although smoking prevalence is decreasing in Hong Kong, there are still 648,800 daily smokers 10.8% (Census and Statistics Department, 2013) and half will be killed by smoking (Lam, 2012) which accounts for over 7,000 deaths per year (Lam, Ho, Hedley, Mak, \& Peto, 2001). Smoking also accounts for a large amount of medical cost, long-term care and productivity loss of US$688 million (0.6% Hong Kong GDP) (Census \& Statistics Department, 2001; McGhee et al., 2006) . Smoking is a highly addictive behavior and it is difficult for smokers with strong nicotine dependence to quit without assistance. On the other hand, reaching and helping the many smokers who have no intention to quit is a challenge, because they are unlikely to seek professional help from smoking cessation services.
The Quit and Win programme provides an opportunity to reach and encourage a large group of smokers to make quit attempt and maintain abstinence. The Quit and Win model posits that smokers participating in the contest will have higher motivation to quit with incentives and better social support (Cahill \& Perera, 2011). Studies have found that such quitting contests or incentive programs appeared to reach a large number of smokers and demonstrated a significantly higher quit rate for the quit and win group than for the control group (Cahill \& Perera, 2008).
Smoking cessation services in Hong Kong are under-used with more than half (60.9%) adult daily smokers who had never used smoking cessation services (Census and Statistics Department, 2013). Among these smokers only 9.6% were willing to use the services. Existing services mostly require self-initiation to seek the services but smokers general lack the will power of initiation. Active referral will help overcome the barriers of self-initiation. There is preliminary evidence that active referral of smokers to smoking cessation hotline services may increase likelihood of smoking abstinence at 12-month follow-up compared with no active referrals (Borland et al., 2008). A recent study has also reported that individuals who used the community-based referral were also more likely to quit than those who did not (43.6% vs 15.3%, P<0.001) (Haas et al., 2015).
Therefore, the present study will examine (1) effectiveness of the active referral and AWARD approaches, (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AWARD, Brief leaflet, Referral leaflet, active referral | Experimental | Behavioral: AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advicesAWARD will be delivered to smokers onsite and this includes: Ask about smoking history, Warn about the high risk, Advise to quit as soon as possible and not later than a quit date (which will qualify them for the QTW prizes), Refer smokers to smoking cessation services, and Do it again: to repeat the intervention. Brief innovative leaflet on health warning and smoking cessation. A 2-side color printed A4 leaflet will be designed to systematically cover the most important messages to motivate smoking cessation. A 2-side color printed A4 referral leaflet will be used for motivate and assist the smokers to use the smoking cessation services. the smokers will be active refer to various smoking cessation services in Hong Kong (using the referral leaflet) and motivate the smokers to use the smoking cessation services. |
| AWARD, Brief leaflet | Experimental | Behavioral: AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advicesAWARD will be delivered to smokers onsite and this includes: Ask about smoking history, Warn about the high risk, Advise to quit as soon as possible and not later than a quit date (which will qualify them for the QTW prizes), Refer smokers to smoking cessation services, and Do it again: to repeat the intervention. Brief innovative leaflet on health warning and smoking cessation. A 2-side color printed A4 leaflet will be designed to systematically cover the most important messages to motivate smoking cessation. |
| Smoking cessation booklet, general advices | Active comparator | Behavioral: AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advicesParticipants will receive minimal intervention, including: (1) the 12-page smoking cessation booklet (provided by COSH); (2) very brief, minimal and general smoking cessation advice include: "Please quit smoking for improving health and save money", "Please refer to the booklet for the details about smoking cessation" and "Please call us if you have any enquiry". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hong Kong residents aged 18 or above
- Smoke at least 1 cigarette per day in the past 3 months
- Able to communicate in Cantonese
- Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO smokerlyzer
- Have Intention to quit
Key exclusion criteria (2 listed)
- Smokers who have difficulties (either physical or cognitive condition) to communicate
- Currently following other smoking cessation programs
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 |
|---|---|---|
| AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advicesUse AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices interventions to achieve smoking abstinence | Behavioural | AWARD, Brief leaflet, AWARD, Brief leaflet, Referral leaflet, active referral, Smoking cessation booklet, general advices |
Primary outcome
smoking quit rate change from baseline at 3-month follow-up
Time frame: 3-month follow-up
The primary outcomes are self-reported 7-day point prevalence (pp) quit rate at 3 and 6 months among the two groups
smoking quit rate change from baseline at 6-month follow-up
Time frame: 6-month follow-up
The primary outcomes are self-reported 7-day point prevalence (pp) quit rate
12 secondary outcomes
Biochemical validated quit rate
Time frame: 3-month follow-up
Biochemical validated quit rate
Time frame: 6-month follow-up
Smoking reduction rate change from baseline at 3-month follow-up
Time frame: 3-month follow-up
Smoking reduction rate change from baseline at 6-month follow-up
Time frame: 6-month follow-up
Smoking quit attempt change from baseline at 3-month follow-up
Time frame: 3-month follow-up
Smoking quit attempt change from baseline at 6-month follow-up
Time frame: 6-month follow-up
quit rate for all subjects change from baseline at 3-month follow-up
Time frame: 3-month follow-up
Reduction rate for all subjects change from baseline at 3-month follow-up
Time frame: 3-month follow-up
quit rate for all subjects change from baseline at 6-month follow-up
Time frame: 6-month follow-up
Reduction rate for all subjects change from baseline at 6-month follow-up
Time frame: 6-month follow-up
quit rate for all subjects change from baseline at 12-month follow-up
Time frame: 12-month follow-up
Reduction rate for all subjects change from baseline at 12-month follow-up
Time frame: 12-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Derived from this study: PubMed 41546550Zeng Y, Wu YS, Luk TT, Zhao SZ, Guo Z, Li Y, Tong HSC, Lai VWY, Cheung YTD, Lam TH, Wang MP. Quitting trajectories of Hong Kong Chinese smokers receiving behavioral smoking cessation interventions: A post hoc analysis of eight randomized controlled trials. Addiction. 2026 Jun;121(6):1568-1579. doi: 10.1111/add.70328. Epub 2026 Jan 17.
- Derived from this study: PubMed 39868569Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
- Derived from this study: PubMed 29059277Wang MP, Suen YN, Li WH, Lam CO, Wu SY, Kwong AC, Lai VW, Chan SS, Lam TH. Intervention With Brief Cessation Advice Plus Active Referral for Proactively Recruited Community Smokers: A Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2017 Dec 1;177(12):1790-1797. doi: 10.1001/jamainternmed.2017.5793.
- Derived from this study: PubMed 27169630Suen YN, Wang MP, Li WH, Kwong AC, Lai VW, Chan SS, Lam TH. Brief advice and active referral for smoking cessation services among community smokers: a study protocol for randomized controlled trial. BMC Public Health. 2016 May 11;16:387. doi: 10.1186/s12889-016-3084-z.
- Individual participant dataSharing planned: Undecided
Related trials for Smoking Cessation Intervention
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
Personalized Tobacco Treatment in Primary Care (MOTIVATE)
Physician's Role, Smoking Cessation
RecruitingPhase 3
Reaching Rural Cancer Survivors Who Smoke Using Text-Based Program
Cigarette Smoking-Related Carcinoma
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
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.
Man Ping Kelvin Wang, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices in people with Smoking Cessation Intervention, run by The University of Hong Kong at 1 site in China.
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 5 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 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
smoking quit rate change from baseline at 3-month follow-up (time frame: 3-month follow-up). The study lists 2 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 NCT02539875, which also lists 4 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 26 Oct 2017.