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Trial record 1 of 1 for:    NCT00808015
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ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking (ASIA CHOICES)

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ClinicalTrials.gov Identifier: NCT00808015
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : July 28, 2011
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date December 12, 2008
First Posted Date December 15, 2008
Results First Submitted Date June 30, 2011
Results First Posted Date July 28, 2011
Last Update Posted Date May 12, 2015
Study Start Date February 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 4, 2011)
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.
Original Primary Outcome Measures
 (submitted: December 12, 2008)
  • Smoking history and quit smoking history [ Time Frame: baseline ]
  • Adverse Events [ Time Frame: post-baseline ]
  • Carbon monoxide concentration [ Time Frame: post-baseline ]
  • Nicotine Use Inventory [ Time Frame: post-baseline ]
Change History
Current Secondary Outcome Measures
 (submitted: August 4, 2011)
  • 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.
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures
 (submitted: December 12, 2008)
  • Subject demography and social status [ Time Frame: baseline ]
  • Health Care Utilization [ Time Frame: baseline ]
  • Medical and cardiovascular history [ Time Frame: baseline ]
  • Subject and family history of mental illness [ Time Frame: baseline ]
  • Fagerstrom Test for Nicotine Dependence [ Time Frame: baseline ]
  • Previous and concomitant Drug Treatment [ Time Frame: baseline ]
  • Non-Drug Treatment/Procedure for Primary Diagnosis [ Time Frame: baseline ]
  • Dosing record [ Time Frame: post-baseline ]
  • Concomitant Drug Treatment [ Time Frame: post-baseline ]
Current Other Pre-specified Outcome Measures
 (submitted: April 21, 2015)
  • 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'.
  • Average Daily Dose of Varenicline [ Time Frame: 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.
  • Concomitant Drug Treatments [ Time Frame: Baseline through Last observed study visit (Week 12 or ET) ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ASIA CHOICES CHampix (Varenicline) Observational Investigation in the CEssation of Smoking
Official Title ASIA CHOICES CHampix Observational Investigation in the CEssation of Smoking
Brief 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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Smoking Cessation
Intervention Drug: varenicline
Champix will be prescribed as per usual practice and at the sole discretion of the physician
Other Name: Champix, Chantix
Study Groups/Cohorts Patients in routine practice
Patients prescribed Champix by treating physician and then entered into trial
Intervention: Drug: varenicline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 30, 2011)
1373
Original Estimated Enrollment
 (submitted: December 12, 2008)
1800
Actual Study Completion Date July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China,   India,   Korea, Republic of,   Philippines
Removed Location Countries  
 
Administrative Information
NCT Number NCT00808015
Other Study ID Numbers A3051112
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2015