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

April 21, 2015 updated by: Pfizer

ASIA CHOICES CHampix Observational Investigation in the CEssation of Smoking

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1373

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100036
        • Pfizer Investigational Site
      • Beijing, China, 100730
        • Pfizer Investigational Site
      • Beijing, China, 100853
        • Pfizer Investigational Site
      • Beijing, China, 100020
        • Pfizer Investigational Site
      • Beijing, China, 100029
        • Pfizer Investigational Site
      • Beijing, China, 100038
        • Pfizer Investigational Site
      • Beijing, China, 100039
        • Pfizer Investigational Site
      • Beijing, China, 100045
        • Pfizer Investigational Site
      • Beijing, China, 100050
        • Pfizer Investigational Site
      • Beijing, China, 100091
        • Pfizer Investigational Site
      • Beijing, China, 100096
        • Pfizer Investigational Site
      • Nanning, China, 530021
        • Pfizer Investigational Site
      • Shanghai, China, 200433
        • Pfizer Investigational Site
      • Shanghai, China, 200032
        • Pfizer Investigational Site
      • Shanghai, China, 200025
        • Pfizer Investigational Site
      • Shanghai, China, 200040
        • Pfizer Investigational Site
      • Shanghai, China, 200080
        • Pfizer Investigational Site
      • Shanghai, China, 200031
        • Pfizer Investigational Site
      • Shanghai, China, 200233
        • Pfizer Investigational Site
      • Shanghai, China, 200065
        • Pfizer Investigational Site
      • Shanghai, China, 200072
        • Pfizer Investigational Site
      • Shanghai, China, 201203
        • Pfizer Investigational Site
      • Shijiazhuang, China, 050011
        • Pfizer Investigational Site
      • Tianjin, China, 300051
        • Pfizer Investigational Site
      • Tianjin, China, 300162
        • Pfizer Investigational Site
      • Tianjin, China, 300280
        • Pfizer Investigational Site
      • Wuhan, China, 430022
        • Pfizer Investigational Site
    • Beijing
      • Beijing, Beijing, China, 100029
        • Pfizer Investigational Site
      • Beijing, Beijing, China, 100083
        • Pfizer Investigational Site
      • Beijing, Beijing, China, 100191
        • Pfizer Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Pfizer Investigational Site
      • Guangzhou, Guangdong, China, 510515
        • Pfizer Investigational Site
      • Guangzhou, Guangdong, China, 510150
        • Pfizer Investigational Site
      • Shenzhen, Guangdong, China, 518020
        • Pfizer Investigational Site
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Pfizer Investigational Site
    • Hunan
      • Changsha, Hunan, China, 410006
        • Pfizer Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Pfizer Investigational Site
      • Suzhou, Jiangsu, China, 215004
        • Pfizer Investigational Site
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • Pfizer Investigational Site
      • Shenyang, Liaoning, China, 110000
        • Pfizer Investigational Site
      • Shenyang, Liaoning, China, 110024
        • Pfizer Investigational Site
      • Shenyang, Liaoning, China, 110042
        • Pfizer Investigational Site
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Pfizer Investigational Site
      • Xi'an, Shaanxi, China, 710032
        • Pfizer Investigational Site
      • Xi'an, Shaanxi, China, 710038
        • Pfizer Investigational Site
      • Xian, Shaanxi, China, 710068
        • Pfizer Investigational Site
    • Shanxi
      • Taiyuan, Shanxi, China, 030012
        • Pfizer Investigational Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Pfizer Investigational Site
    • Tianjin
      • Tianjin, Tianjin, China, 300192
        • Pfizer Investigational Site
  • India
      • Chennai, India, 600 032
        • Pfizer Investigational Site
      • Delhi, India, 110088
        • Pfizer Investigational Site
      • New Delhi, India, 110 016
        • Pfizer Investigational Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500029
        • Pfizer Investigational Site
    • Delhi
      • New Delhi, Delhi, India, 110 076
        • Pfizer Investigational Site
    • Gujarat
      • Ahmadabad, Gujarat, India, 380005
        • Pfizer Investigational Site
    • Kerala
      • Cochin, Kerala, India, 682026
        • Pfizer Investigational Site
      • Tthiruvananthapuram, Kerala, India, 695504
        • Pfizer Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 022
        • Pfizer Investigational Site
      • Mumbai, Maharashtra, India, 400 070
        • Pfizer Investigational Site
      • Mumbai, Maharashtra, India, 400008
        • Pfizer Investigational Site
      • Mumbai, Maharashtra, India, 400036
        • Pfizer Investigational Site
    • New Delhi
      • Daryaganj, New Delhi, India, 110 002
        • Pfizer Investigational Site
      • Delhi, New Delhi, India, 110017
        • Pfizer Investigational Site
      • Delhi, New Delhi, India, 110085
        • Pfizer Investigational Site
      • Delhi,, New Delhi, India, 110027
        • Pfizer Investigational Site
    • Tamil Nadu
      • Coimbatore, Tamil Nadu, India, 641045
        • Pfizer Investigational Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-718
        • Pfizer Investigational Site
      • Daegu, Korea, Republic of, 705-717
        • Pfizer Investigational Site
      • Daegu-si, Korea, Republic of, 700-712
        • Pfizer Investigational Site
      • Daejeon, Korea, Republic of, 301-721
        • Pfizer Investigational Site
      • Daejeon, Korea, Republic of, 301-804
        • Pfizer Investigational Site
      • Incheon, Korea, Republic of, 405-760
        • Pfizer Investigational Site
      • Incheon-Si, Korea, Republic of, 403-720
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of
        • Pfizer Investigational Site
      • Suwon, Korea, Republic of, 443-721
        • Pfizer Investigational Site
    • Chungcheongnam-do
      • Cheonan-si, Chungcheongnam-do, Korea, Republic of, 330-715
        • Pfizer Investigational Site
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 411-719
        • Pfizer Investigational Site
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Pfizer Investigational Site
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 442-723
        • Pfizer Investigational Site
    • Gyeongnam
      • Yangsan-si, Gyeongnam, Korea, Republic of, 626-770
        • Pfizer Investigational Site
    • Jeollabuk-Do
      • Iksan-Si, Jeollabuk-Do, Korea, Republic of, 570-711
        • Pfizer Investigational Site
  • Philippines
      • Davao City, Philippines, 8000
        • Pfizer Investigational Site
      • Marikina City, Philippines
        • Pfizer Investigational Site
      • Pasay City, Philippines, 1301
        • Pfizer Investigational Site
      • Quezon City, Philippines, 1100
        • Pfizer Investigational Site
      • Quezon City, Philippines
        • Pfizer Investigational Site
      • Quezon City, Philippines, 1103
        • Pfizer Investigational Site
    • Batangas
      • San Juan, Batangas, Philippines
        • Pfizer Investigational Site
    • Ilocos Norte
      • Batac, Ilocos Norte, Philippines, 2906
        • Pfizer Investigational Site
    • La Union
      • San Fernando City, La Union, Philippines, 2500
        • Pfizer Investigational Site
    • Pampanga
      • Angeles City, Pampanga, Philippines
        • Pfizer Investigational Site
    • Pangasinan
      • Urdaneta City, Pangasinan, Philippines
        • Pfizer Investigational Site
    • Tarlac
      • Tarlac City, Tarlac, Philippines
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients in routine practice
Patients prescribed Champix by treating physician and then entered into trial
Drug: varenicline
Champix will be prescribed as per usual practice and at the sole discretion of the physician
Other Names:
  • Champix, Chantix

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit
Time Frame: Last observed study visit (Week 12 or early termination [ET])
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.
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
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.
Week 3 through Week 11
CO Level at Last Observed Study Visit
Time Frame: Last observed study visit (Week 12 or ET)
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.
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)
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).
Last observed study visit (Week 12 or ET)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Varenicline Prescription Status
Time Frame: After last observed study visit (Week 12 or ET)
Prescribed status was assessed using the following question in consent record form: Would a maintenance period of the drug be prescribed to the participant after this study ends (Yes/No). Missing values were recorded as 'unknown'.
After last observed study visit (Week 12 or ET)
Average Daily Dose of Varenicline
Time Frame: Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET)
Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET)
Median Duration of Treatment of Varenicline
Time Frame: Baseline through last observed study visit (Week 12 or ET)
The duration was defined as the total number of dosing days from first to last day of each study treatment.
Baseline through last observed study visit (Week 12 or ET)
Concomitant Drug Treatments
Time Frame: Baseline through Last observed study visit (Week 12 or ET)
Baseline through Last observed study visit (Week 12 or ET)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3051112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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