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

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: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: varenicline

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: Observational
• Enrollment (Actual): 1373

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	Last observed study visit (Week 12 or ET)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Varenicline Prescription Status	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		Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET)
Median Duration of Treatment of Varenicline	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		Baseline through Last observed study visit (Week 12 or ET)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: December 12, 2008
• First Submitted That Met QC Criteria: December 12, 2008
• First Posted (Estimate): December 15, 2008

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: April 21, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Observational non-interventional trial
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: A3051112