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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00808015
First received: December 12, 2008
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Smoking Cessation
Drug: varenicline

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ASIA CHOICES CHampix Observational Investigation in the CEssation of Smoking

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Smoking Abstinence at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Smoking Abstinence Before Last Observed Study Visit [ Time Frame: Last observed study visit (Week 12 or early termination [ET]) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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).


Enrollment: 1373
Study Start Date: February 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Champix, Chantix

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808015

  Show 97 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00808015     History of Changes
Other Study ID Numbers: A3051112
Study First Received: December 12, 2008
Results First Received: June 30, 2011
Last Updated: August 4, 2011
Health Authority: India: Central Drugs Standard Control Organization

Keywords provided by Pfizer:
Observational non-interventional trial

Additional relevant MeSH terms:
Smoking
Habits
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014