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Completed

NCT Number: NCT00808015

ASIA CHOICES CHampix (Varenicline) 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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Beijing, Beijing Municipality, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Varenicline

Drug

Champix will be prescribed as per usual practice and at the sole discretion of the physician

Other names: Champix, Chantix

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Other outcomes

  1. 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'.

  2. Average Daily Dose of Varenicline

    Time frame: Days 1-3, Days 4-7, Day 8 through last observed study visit (Week 12 or ET)

  3. 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.

  4. Concomitant Drug Treatments

    Time frame: Baseline through Last observed study visit (Week 12 or ET)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

ASIA CHOICES CHampix Observational Investigation in the CEssation of Smoking

Acronym: ASIA CHOICES

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 15, 2008
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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