Chantix Clinical Trial Data

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Clinical Studies

Chantix was studied in six clinical trials in which over three and a half thousand smokers, who were smoking 10 cigarettes or more per day, were treated with Chantix. To check whether patients had stopped smoking, they:

• reported it themselves
• had their breath measure for the presence of carbon monoxide at weekly intervals. A CO measurement of less than or equal to 10 parts per million was considered to indicate that the patient was not smoking.

65% of patients who started the trial, completed it. Patients on 4 out of the 6 studies received treatment with Chantix for 12 weeks. They were monitored for a further 40 weeks after the treatment had been completed. The majority of participants were caucasian and there were approximately equal numbers of men and women. All patients received a booklet on how to quit smoking, together with counseling. Patients set a date to quit smoking, and treatment with Chantix commenced a week prior to this.

Summary of the Studies

• Study 1 lasted for 6 weeks only and provided evidence that Chantix was more effective than a placebo in aiding people to quit smoking. Doses of 1 mg and 2 mg Chantix per day were evaluated.
• Study 2 - Patients were treated for 12 weeks with either 1 mg or 2 mg of Chantix per day, or a placebo. In this study, 45% of participants taking 1 mg / day and 51% of participants taking 2mg / day abstained from smoking during weeks 9 - 12. This compared with 12% in the placebo group.
• Study 3 - This study allowed patients themselves to adjust the dose of Chantix they received. They started for one week at a dose of 0.5 mg. Thereafter, they could adjust the dosage as they wished between 0.5 mg and 1 mg / day. Of the treated subjects, 44% abstained from smoking from weeks 9-12, compared with 8% in the placebo group.
• Study 4 and Study 5 - These studies were identical double blind, and compared treatments of a placebo, 2 mg of Chantix and 150 mg of sustained release Zyban. Both studies showed increase rate of abstinence from cigarettes in the treated groups, and the rate of abstinence at weeks 9-12 was greater in the Chantix group than the Zyban treated group.
• Study 6 - This study assessed whether a course of a further 12 weeks of treatment with Chantix would improve the long term rates of smoking cessation. Only patients who had stopped smoking by week 12 were used. They were randomised and one group were given a placebo, the other group were treated with Chantix. The treated group were more likely not to smoke during this 12 weeks period (70% compared to 50% in the control). After 28 weeks, the figures for the treated and control groups had dropped to 54% and 39% respectively.
  
  

Table to compare the percentage of patients who abstained from smoking from weeks 9 thro 52

Graph showing the percentage of participants abstaining from smoking during weeks 9 - 52