Smoking CessationASIA CHOICESNCT00808015

ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking

An observational study of Smoking Cessation, run by Pfizer at 97 sites in 4 countries.

Completed

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

Trial summary

The purpose of this study is to describe the characteristics of the smoker who wants to quit and his/her treating physician, in addition to determine the safety and effectiveness of Champix in the real-world setting of smokers in routine clinical practice. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking Cessation
What is being tested?: varenicline
How many people: 1,373 participants
Where: 97 sitesin 4 countries
Study dates: Feb 2009to Jul 2010
Phase: Observational
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: This study is in Asian patients. The patients enrolled should be of legal adult age who regularly smoke and whose main tobacco product is cigarettes. The patients must be willing to make an attempt to stop smoking.

Who may be able to join

All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion

Who cannot join

All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion

Trial locations and contacts

97 sites in 4 countries.

Country

City, postcode or hospital

97 sites in 4 countries

China49 sites

Pfizer Investigational Site
Beijing, Beijing Municipality, 100029
Pfizer Investigational Site
Beijing, Beijing Municipality, 100083
Pfizer Investigational Site
Beijing, Beijing Municipality, 100191
Pfizer Investigational Site
Beijing, 100020
Pfizer Investigational Site
Beijing, 100029
Pfizer Investigational Site
Beijing, 100036
Pfizer Investigational Site
Beijing, 100038
Pfizer Investigational Site
Beijing, 100039
Pfizer Investigational Site
Beijing, 100045
Pfizer Investigational Site
Beijing, 100050
Pfizer Investigational Site
Beijing, 100091
Pfizer Investigational Site
Beijing, 100096
Pfizer Investigational Site
Beijing, 100730
Pfizer Investigational Site
Beijing, 100853
Pfizer Investigational Site
Changsha, Hunan, 410006
Pfizer Investigational Site
Chengdu, Sichuan, 610041
Pfizer Investigational Site
Guangzhou, Guangdong, 510080
Pfizer Investigational Site
Guangzhou, Guangdong, 510150
Pfizer Investigational Site
Guangzhou, Guangdong, 510515
Pfizer Investigational Site
Nanjing, Jiangsu, 210009
Pfizer Investigational Site
Nanning, 530021
Pfizer Investigational Site
Shanghai, 200025
Pfizer Investigational Site
Shanghai, 200031
Pfizer Investigational Site
Shanghai, 200032
Pfizer Investigational Site
Shanghai, 200040
Pfizer Investigational Site
Shanghai, 200065
Pfizer Investigational Site
Shanghai, 200072
Pfizer Investigational Site
Shanghai, 200080
Pfizer Investigational Site
Shanghai, 200233
Pfizer Investigational Site
Shanghai, 200433
Pfizer Investigational Site
Shanghai, 201203
Pfizer Investigational Site
Shenyang, Liaoning, 110000
Pfizer Investigational Site
Shenyang, Liaoning, 110016
Pfizer Investigational Site
Shenyang, Liaoning, 110024
Pfizer Investigational Site
Shenyang, Liaoning, 110042
Pfizer Investigational Site
Shenzhen, Guangdong, 518020
Pfizer Investigational Site
Shijiazhuang, 050011
Pfizer Investigational Site
Suzhou, Jiangsu, 215004
Pfizer Investigational Site
Taiyuan, Shanxi, 030012
Pfizer Investigational Site
Tianjin, Tianjin Municipality, 300192
Pfizer Investigational Site
Tianjin, 300051
Pfizer Investigational Site
Tianjin, 300162
Pfizer Investigational Site
Tianjin, 300280
Pfizer Investigational Site
Wuhan, Hubei, 430060
Pfizer Investigational Site
Wuhan, 430022
Pfizer Investigational Site
Xi'an, Shaanxi, 710004
Pfizer Investigational Site
Xi'an, Shaanxi, 710032
Pfizer Investigational Site
Xi'an, Shaanxi, 710038
Pfizer Investigational Site
Xi'an, Shaanxi, 710068

Other trials in China

South Korea19 sites

Pfizer Investigational Site
Cheonan-si, Chungcheongnam-do, 330-715
Pfizer Investigational Site
Daegu, 700-712
Pfizer Investigational Site
Daegu, 705-717
Pfizer Investigational Site
Daegu, 705-718
Pfizer Investigational Site
Daejeon, 301-721
Pfizer Investigational Site
Daejeon, 301-804
Pfizer Investigational Site
Goyang-si, Gyeonggi-do, 411-719
Pfizer Investigational Site
Iksan-Si, Jeollabuk-do, 570-711
Pfizer Investigational Site
Incheon, 403-720
Pfizer Investigational Site
Incheon, 405-760
Pfizer Investigational Site
Seongnam-si, Gyeonggi-do, 463-707
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 120-752
Pfizer Investigational Site
Seoul, 137-701
Pfizer Investigational Site
Seoul, 138-736
Pfizer Investigational Site
Seoul
Pfizer Investigational Site
Suwon, Gyeonggi-do, 442-723
Pfizer Investigational Site
Suwon, 443-721
Pfizer Investigational Site
Yangsan, Gyeongsangnam-do, 626-770

Other trials in South Korea

India17 sites

Pfizer Investigational Site
Ahmedabad, Gujarat, 380005
Pfizer Investigational Site
Chennai, 600 032
Pfizer Investigational Site
Coimbatore, Tamil Nadu, 641045
Pfizer Investigational Site
Daryāganj, New Delhi, 110 002
Pfizer Investigational Site
Delhi, National Capital Territory of Delhi, 110088
Pfizer Investigational Site
Delhi, New Delhi, 110017
Pfizer Investigational Site
Delhi, New Delhi, 110027
Pfizer Investigational Site
Delhi, New Delhi, 110085
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500029
Pfizer Investigational Site
Kochi, Kerala, 682026
Pfizer Investigational Site
Mumbai, Maharashtra, 400 022
Pfizer Investigational Site
Mumbai, Maharashtra, 400 070
Pfizer Investigational Site
Mumbai, Maharashtra, 400008
Pfizer Investigational Site
Mumbai, Maharashtra, 400036
Pfizer Investigational Site
New Delhi, National Capital Territory of Delhi, 110 076
Pfizer Investigational Site
New Delhi, New Delhi, 110 016
Pfizer Investigational Site
Tthiruvananthapuram, Kerala, 695504

Other trials in India

Philippines12 sites

Pfizer Investigational Site
Angeles City, Pampanga
Pfizer Investigational Site
Batac, Ilocos Norte, 2906
Pfizer Investigational Site
Davao City, 8000
Pfizer Investigational Site
Marikina City
Pfizer Investigational Site
Pasay, 1301
Pfizer Investigational Site
Quezon City, 1100
Pfizer Investigational Site
Quezon City, 1103
Pfizer Investigational Site
Quezon City
Pfizer Investigational Site
San Fernando City, La Union, 2500
Pfizer Investigational Site
San Juan City, Batangas
Pfizer Investigational Site
Tarlac City, Tarlac
Pfizer Investigational Site
Urdaneta, Pangasinan

Other trials in Philippines

About this study

Official title: ASIA CHOICES CHampix Observational Investigation in the CEssation of Smoking

Read the detailed description

Sampling Method Description: Patients enrolled after being prescribed Champix for smoking cessation at the sole discretion of treating physician and patient.

Conditions: Smoking Cessation
Being tested: varenicline
Keywords: Observational non-interventional trial
Medical subject headings: Smoking Cessation

What participants receive

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

vareniclineDrug
Also called Champix, Chantix
Champix will be prescribed as per usual practice and at the sole discretion of the physician

Study groups in NCT00808015
Study group	Role	What they receive
Patients in routine practice		Patients prescribed Champix by treating physician and then entered into trial Receives: Drug: varenicline

What is being measured

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

Percentage of Participants With Smoking Abstinence at Week 12
Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.
Measured: Week 12

Secondary outcomes (4)

Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit
Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.
Measured: Last observed study visit (Week 12 or early termination [ET])
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.
Measured: Week 3 through Week 11
CO Level at Last Observed Study Visit
The CO level was measured from exhaled air of the participant using CO analyzer at the last observed study visit which was the last available CO level recorded after baseline. The CO level was only measured if it was a part of the usual practice at the site.
Measured: Last observed study visit (Week 12 or ET)
Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit
The average number of cigarettes smoked per day over the last 7 days was collected as a part of nicotine use inventory assessment through consent record form module which included a questionnaire: Did the participant smoke any cigarettes (even a puff) in last 7 days (Yes/No) and Did the participant use any other tobacco products (example- pipe, cigars, chew, snuff) in last 7 days (Yes/No).
Measured: Last observed study visit (Week 12 or ET)

Timeline

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

Feb 2009Jul 2010

First posted15 Dec 2008 (estimated)
Study startFeb 2009
Primary completionJul 2010
Study completionJul 2010

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 Smoking CessationStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 1,373 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00808015
Sponsor's protocol ID: A3051112
Acronym: ASIA CHOICES
Status last verified: Apr 2015
First submitted: 12 Dec 2008
Last updated: 12 May 2015
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

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation

All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ASIA CHOICES CHampix Observational Investigation in the CEssation of Smoking
ClinicalTrials.gov ID: NCT00808015
Acronym / sponsor ID: ASIA CHOICES / A3051112
Conditions: Smoking Cessation
Keywords: Observational non-interventional trial
Study type: Observational
Recruitment status: Completed
Enrolment: 1,373 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 15 Dec 2008 (estimated)
Results: Posted 28 Jul 2011

Clinical summary

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

Detailed description

Sampling Method Description: Patients enrolled after being prescribed Champix for smoking cessation at the sole discretion of treating physician and patient.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients in routine practice	–	Drug: vareniclinePatients prescribed Champix by treating physician and then entered into trial

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This study is in Asian patients. The patients enrolled should be of legal adult age who regularly smoke and whose main tobacco product is cigarettes. The patients must be willing to make an attempt to stop smoking.

Key inclusion criteria (1 listed)

All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion

Key exclusion criteria (1 listed)

All patients enrolled should meet the usual prescribing criteria for Champix® as per the local product information and should be entered into the trial at the investigator's discretion

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
vareniclineAlso: Champix, ChantixChampix will be prescribed as per usual practice and at the sole discretion of the physician	Drug	Patients in routine practice

Primary outcome

Percentage of Participants With Smoking Abstinence at Week 12
Time frame: Week 12
Four criteria used for derivation of smoking abstinence status: if participant smoked any cigarettes (even a puff) in last 7 days (Yes/No); if participant used any other tobacco products in last 7 days (Yes/No); average number of cigarettes smoked per day over last 7 days (in cigarettes/day); CO level (positive: if more than 10 ppm; negative : if 0-10 ppm).Smoking abstinence status was determined as: smoking: if participant responded positively to at least 1 of above 4; quit: if participant responded negatively to all 4; unknown: if participant had missing information for all 4.

4 secondary outcomes

Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit
Time frame: Last observed study visit (Week 12 or early termination [ET])
Percentage of Participants With Smoking Abstinence Status From Week 3 to Week 11
Time frame: Week 3 through Week 11
CO Level at Last Observed Study Visit
Time frame: Last observed study visit (Week 12 or ET)
Average Weekly Number of Cigarettes Smoked at Last Observed Study Visit
Time frame: Last observed study visit (Week 12 or ET)

Results and safety

Results posted to the registry on 28 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Varenicline	1,377	1,033

Primary outcome: Percentage of Participants With Smoking Abstinence at Week 12

Time frame: Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Varenicline n = 1373
Value	46.40 (43.73 to 49.07)

Population analysed: Full analysis set (FAS) included all participants who received at least 1 dose of study medication

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varenicline	11 of 1,373 (0.8%)	379 of 1,373 (27.6%)	Not reported

Limitations and caveats (from the sponsor): Outcome measures were not designated as primary or secondary measures as this study was a post-marketing, prospective, non-comparative and non-interventional study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Smoking Cessation

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
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.

Pfizer CT.gov Call Center study director

Pfizer

97 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Smoking Cessation, run by Pfizer at 97 sites in 4 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 1 inclusion and 1 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 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in China, South Korea, India, 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. 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?

Yes. Results are posted in the registry (first posted 28 Jul 2011). 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?

Percentage of Participants With Smoking Abstinence at Week 12 (time frame: Week 12). 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 NCT00808015.

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 12 May 2015.