Trial Outcomes & Findings for Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD). (NCT NCT00285012)
NCT ID: NCT00285012
Last Updated: 2010-04-20
Results Overview
Number of subjects who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory \[NUI\]) and with end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm) for weeks 9 through 12 (inclusive).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
504 participants
Primary outcome timeframe
Week 9 through Week 12
Results posted on
2010-04-20
Participant Flow
Subjects were current cigarette smokers 35 years of age or older with mild to moderate Chronic Obstructive Pulmonary Disease (COPD) as defined by Global Initiative for Chronic Obstructive Lung Diseases (GOLD) criteria.
Participant milestones
| Measure |
Varenicline
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Assigned to Study Treatment (Tx)
STARTED
|
250
|
254
|
|
Assigned to Study Treatment (Tx)
COMPLETED
|
248
|
251
|
|
Assigned to Study Treatment (Tx)
NOT COMPLETED
|
2
|
3
|
|
Received Study Tx
STARTED
|
248
|
251
|
|
Received Study Tx
Completed Tx (May Continue in Study)
|
207
|
193
|
|
Received Study Tx
Discontinued Tx (May Continue in Study)
|
41
|
58
|
|
Received Study Tx
COMPLETED
|
176
|
157
|
|
Received Study Tx
NOT COMPLETED
|
72
|
94
|
Reasons for withdrawal
| Measure |
Varenicline
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Assigned to Study Treatment (Tx)
Other
|
2
|
3
|
|
Received Study Tx
Death
|
2
|
1
|
|
Received Study Tx
Adverse Event
|
5
|
11
|
|
Received Study Tx
Lack of Efficacy
|
0
|
3
|
|
Received Study Tx
Lost to Follow-up
|
29
|
31
|
|
Received Study Tx
Withdrawal by Subject
|
31
|
43
|
|
Received Study Tx
Other
|
5
|
5
|
Baseline Characteristics
Smoking Cessation in Subjects With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD).
Baseline characteristics by cohort
| Measure |
Varenicline
n=248 Participants
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
n=251 Participants
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Total
n=499 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.2 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
57.1 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
155 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
311 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 9 through Week 12Population: All subjects population: received at least 1 dose, including partial doses, of randomized study drug.
Number of subjects who reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory \[NUI\]) and with end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm) for weeks 9 through 12 (inclusive).
Outcome measures
| Measure |
Varenicline
n=248 Participants
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
n=251 Participants
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Number of Subjects With Four Week Continuous Quit Rate (CQR)
|
105 participants
|
22 participants
|
SECONDARY outcome
Timeframe: Week 9 through Week 24 and Week 52Population: All subjects population
Number of subjects who reported no smoking and no use of other nicotine-containing products (treatment phase = through week 12) or tobacco products (non-treatment phase = after treatment phase; follow up through week 52) at each contact (on the NUI) and with end-expiratory exhaled CO measurement less than or equal to 10 ppm from week 9 through week 24 and week 52. CO confirmed in-clinic visit.
Outcome measures
| Measure |
Varenicline
n=248 Participants
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
n=251 Participants
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Number of Subjects With Continuous Abstinence (CA)
Week 9
|
125 participants
|
28 participants
|
|
Number of Subjects With Continuous Abstinence (CA)
Week 24
|
64 participants
|
18 participants
|
|
Number of Subjects With Continuous Abstinence (CA)
Week 52
|
46 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Week 24, Week 52Population: All subjects population
Number of subjects who were responders for the primary endpoint (4-week CQR for Weeks 9 through 12) and who had no more than 6 cumulative days of smoking from Week 12 through the given visit (Week 24 and Week 52). CO confirmed in-clinic visit.
Outcome measures
| Measure |
Varenicline
n=248 Participants
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
n=251 Participants
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Number of Subjects With Long Term Quit Rate (LTQR)
Week 24
|
70 participants
|
19 participants
|
|
Number of Subjects With Long Term Quit Rate (LTQR)
Week 52
|
53 participants
|
17 participants
|
SECONDARY outcome
Timeframe: Week 12, Week 24, Week 52Population: All subjects population
Number of subjects at given visit (Week 12, Week 24, Week 52) or telephone contact, reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) in the last 7 days and with end-expiratory exhaled CO measurement less than or equal to 10 ppm. CO confirmed in-clinic visit.
Outcome measures
| Measure |
Varenicline
n=248 Participants
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
n=251 Participants
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Number of Subjects With 7-Day Point Prevalence of Abstinence
Week 12
|
119 participants
|
31 participants
|
|
Number of Subjects With 7-Day Point Prevalence of Abstinence
Week 24
|
74 participants
|
34 participants
|
|
Number of Subjects With 7-Day Point Prevalence of Abstinence
Week 52
|
65 participants
|
36 participants
|
SECONDARY outcome
Timeframe: Week 52Population: All subjects population
Number of subjects at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks and with end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Outcome measures
| Measure |
Varenicline
n=248 Participants
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
n=251 Participants
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Number of Subjects With 4-Week Point Prevalence of Abstinence
|
65 particpants
|
33 particpants
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 52Population: All subjects population; (n) = subjects with analyzable data at observation for varenicline and placebo, respectively. Missing data imputed by carrying the last observation forward (LOCF), including baseline values.
Change from baseline in mean FEV1 (forced expiratory volume in the first second of forced exhalation) measured in millimeters (ml) as mean at observation minus baseline value. Directly after pre-bronchodilator measurement, subject inhaled albuterol or salbutamol delivered by metered-dose inhaler (MDI); post-bronchodilator lung function repeated 30 to 45 minutes following administration of albuterol or salbutamol.
Outcome measures
| Measure |
Varenicline
n=248 Participants
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
n=251 Participants
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Week 12 [LOCF] Pre-bronchodilator (n= 244, 248)
|
33.69 ml
Standard Deviation 281.08
|
1.77 ml
Standard Deviation 282.28
|
|
Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Week 12 [LOCF] Post-bronchodilator (n=237, 246)
|
73.84 ml
Standard Deviation 287.20
|
15.61 ml
Standard Deviation 223.02
|
|
Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Week 52 [LOCF] Pre-bronchodilator (n=244, 248)
|
-29.59 ml
Standard Deviation 276.53
|
-37.90 ml
Standard Deviation 286.47
|
|
Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Week 52 [LOCF] Post-bronchodilator (n=237, 246)
|
-8.10 ml
Standard Deviation 285.80
|
-9.51 ml
Standard Deviation 277.46
|
SECONDARY outcome
Timeframe: Baseline, Week, 12, Week 24, Week 52Population: All subjects; (n) = subjects with analyzable data at observation for varenicline and placebo, respectively.
Change from baseline: mean at observation minus baseline value. Subject-administered 10-item instrument to systematically assess COPD symptoms (items 1, 2, 5, and 6), functional states (items 7, 8, 9, and 10) and mental states (items 3 and 4); For each domain score = sum of items divided by the number of items; total score = sum of scores divided by 10; range from 0 (very good health) to 6 (extremely poor health). Assessed at each visit based on subject's experience during the week prior to visit.
Outcome measures
| Measure |
Varenicline
n=248 Participants
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
n=251 Participants
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Change From Baseline in Clinical COPD Questionnaire (CCQ)
Week 12 Mental State (n=214, 193)
|
-0.81 scores on scale
Standard Deviation 1.25
|
-0.64 scores on scale
Standard Deviation 1.31
|
|
Change From Baseline in Clinical COPD Questionnaire (CCQ)
Week 52 Total Score (n=174, 154)
|
-0.62 scores on scale
Standard Deviation 0.89
|
-0.39 scores on scale
Standard Deviation 1.05
|
|
Change From Baseline in Clinical COPD Questionnaire (CCQ)
Week 24 Mental State (n=191, 161)
|
-0.72 scores on scale
Standard Deviation 1.36
|
-0.49 scores on scale
Standard Deviation 1.43
|
|
Change From Baseline in Clinical COPD Questionnaire (CCQ)
Week 52 Mental State (n=174, 155)
|
-0.58 scores on scale
Standard Deviation 1.37
|
-0.46 scores on scale
Standard Deviation 1.39
|
|
Change From Baseline in Clinical COPD Questionnaire (CCQ)
Week 12 Functional State (n=214, 192)
|
-0.41 scores on scale
Standard Deviation 0.98
|
-0.35 scores on scale
Standard Deviation 1.00
|
|
Change From Baseline in Clinical COPD Questionnaire (CCQ)
Week 24 Functional State (n=191, 160)
|
-0.40 scores on scale
Standard Deviation 1.01
|
-0.25 scores on scale
Standard Deviation 1.02
|
|
Change From Baseline in Clinical COPD Questionnaire (CCQ)
Week 52 Functional State (n=175, 154)
|
-0.35 scores on scale
Standard Deviation 0.96
|
-0.12 scores on scale
Standard Deviation 1.06
|
|
Change From Baseline in Clinical COPD Questionnaire (CCQ)
Week 12 Respiratory Symptoms (n=213, 193)
|
-1.16 scores on scale
Standard Deviation 1.19
|
-0.88 scores on scale
Standard Deviation 1.17
|
|
Change From Baseline in Clinical COPD Questionnaire (CCQ)
Week 24 Respiratory Symptoms (n=191, 161)
|
-0.98 scores on scale
Standard Deviation 1.08
|
-0.82 scores on scale
Standard Deviation 1.14
|
|
Change From Baseline in Clinical COPD Questionnaire (CCQ)
Week 52 Respiratory Symptoms (n=175, 155)
|
-0.90 scores on scale
Standard Deviation 1.16
|
-0.63 scores on scale
Standard Deviation 1.36
|
|
Change From Baseline in Clinical COPD Questionnaire (CCQ)
Week 12 Total Score (n=213, 192)
|
-0.79 scores on scale
Standard Deviation 0.91
|
-0.62 scores on scale
Standard Deviation 0.93
|
|
Change From Baseline in Clinical COPD Questionnaire (CCQ)
Week 24 Total Score (n=191, 160)
|
-0.70 scores on scale
Standard Deviation 0.89
|
-0.52 scores on scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: Day 1 through Day 21Population: All subjects population; (n) = number of subjects who smoked at least 1 cigarette at the given day for varenicline and placebo, respectively.
Number of cigarettes smoked daily collected during the first 3 weeks of study after randomization using patient smoking diaries.
Outcome measures
| Measure |
Varenicline
n=248 Participants
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
n=251 Participants
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 20 (n=121, 162)
|
9.7 cigarettes per day
Standard Deviation 8.6
|
11.3 cigarettes per day
Standard Deviation 7.9
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 1 (n=226, 231)
|
19.9 cigarettes per day
Standard Deviation 11.0
|
18.7 cigarettes per day
Standard Deviation 9.8
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 2 (n=232, 230)
|
18.8 cigarettes per day
Standard Deviation 10.6
|
18.4 cigarettes per day
Standard Deviation 9.7
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 3 (n=233, 233)
|
17.7 cigarettes per day
Standard Deviation 9.9
|
17.4 cigarettes per day
Standard Deviation 9.6
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 4 (n=230, 232)
|
17.1 cigarettes per day
Standard Deviation 9.7
|
17.1 cigarettes per day
Standard Deviation 9.5
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 5 (n=224, 228)
|
16.5 cigarettes per day
Standard Deviation 9.6
|
16.9 cigarettes per day
Standard Deviation 9.3
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 6 (n=222, 230)
|
16.4 cigarettes per day
Standard Deviation 9.9
|
16.0 cigarettes per day
Standard Deviation 9.1
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 7 (n=214, 228)
|
15.9 cigarettes per day
Standard Deviation 11.3
|
15.3 cigarettes per day
Standard Deviation 9.9
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 8 (n=176, 201)
|
13.9 cigarettes per day
Standard Deviation 12.0
|
13.4 cigarettes per day
Standard Deviation 9.9
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 9 (n=168, 193)
|
12.2 cigarettes per day
Standard Deviation 9.8
|
12.7 cigarettes per day
Standard Deviation 9.5
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 10 (155, 187)
|
12.1 cigarettes per day
Standard Deviation 9.1
|
12.6 cigarettes per day
Standard Deviation 8.9
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 11 (n=151, 190)
|
11.6 cigarettes per day
Standard Deviation 8.3
|
12.1 cigarettes per day
Standard Deviation 9.0
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 12 (n=145, 188)
|
11.4 cigarettes per day
Standard Deviation 8.5
|
11.9 cigarettes per day
Standard Deviation 8.9
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 13 (n=144, 184)
|
11.1 cigarettes per day
Standard Deviation 8.5
|
11.9 cigarettes per day
Standard Deviation 8.9
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 14 (n=134, 183)
|
11.1 cigarettes per day
Standard Deviation 8.8
|
12.9 cigarettes per day
Standard Deviation 11.6
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 15 (n=131, 180)
|
11.1 cigarettes per day
Standard Deviation 8.5
|
11.5 cigarettes per day
Standard Deviation 8.7
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 16 (n=132, 179)
|
10.8 cigarettes per day
Standard Deviation 8.7
|
11.9 cigarettes per day
Standard Deviation 9.2
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 17 (n=128, 176)
|
10.5 cigarettes per day
Standard Deviation 8.3
|
11.9 cigarettes per day
Standard Deviation 9.3
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 18 (n=123, 176)
|
10.7 cigarettes per day
Standard Deviation 8.3
|
11.9 cigarettes per day
Standard Deviation 9.3
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 19 (n=120, 176)
|
10.1 cigarettes per day
Standard Deviation 7.9
|
11.6 cigarettes per day
Standard Deviation 8.7
|
|
Number of Cigarettes Smoked Daily During First 3 Weeks of the 12-Week Treatment Period
Day 21 (n=100, 132)
|
9.8 cigarettes per day
Standard Deviation 8.8
|
10.4 cigarettes per day
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 52Population: All subjects population; (n) = number of subjects with analyzable data at observation for varenicline and placebo, respectively.
Change from baseline in CRP and Fibrinogen antigen (blood markers of inflammation) calculated as mean at observation minus baseline value; measured as milligrams per deciliter (mg/dl).
Outcome measures
| Measure |
Varenicline
n=248 Participants
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
n=251 Participants
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen
Week 12 CRP (n=210, 197)
|
-0.0 mg/dl
Standard Deviation 1.0
|
-0.0 mg/dl
Standard Deviation 1.0
|
|
Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen
Week 52 CRP (n=162, 146)
|
0.0 mg/dl
Standard Deviation 0.9
|
0.1 mg/dl
Standard Deviation 0.8
|
|
Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen
Week 12 Fibrinogen (n=183, 174)
|
-25.2 mg/dl
Standard Deviation 100.6
|
-1.4 mg/dl
Standard Deviation 86.9
|
|
Change From Baseline in Inflammatory Biomarkers: C-Reactive Protein (CRP) and Fibrinogen Antigen
Week 52 Fibrinogen (n=150, 130)
|
-8.2 mg/dl
Standard Deviation 102.1
|
14.9 mg/dl
Standard Deviation 79.2
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Subjects with change in body weight in the All subjects population
Change from baseline calculated as mean at observation minus baseline value; body weight measured in kilograms (kg).
Outcome measures
| Measure |
Varenicline
n=217 Participants
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
n=205 Participants
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Change From Baseline in Body Weight
|
2.4 kg
Standard Deviation 6.3
|
1.5 kg
Standard Deviation 4.0
|
Adverse Events
Varenicline
Serious events: 6 serious events
Other events: 157 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 121 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=248 participants at risk
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
n=251 participants at risk
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.40%
1/248
|
0.40%
1/251
|
|
Cardiac disorders
Angina pectoris
|
0.40%
1/248
|
0.00%
0/251
|
|
General disorders
Chest pain
|
0.00%
0/248
|
0.40%
1/251
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/248
|
0.40%
1/251
|
|
Infections and infestations
Appendicitis
|
0.00%
0/248
|
0.40%
1/251
|
|
Infections and infestations
Bronchitis
|
0.00%
0/248
|
0.40%
1/251
|
|
Infections and infestations
Cellulitis
|
0.40%
1/248
|
0.00%
0/251
|
|
Infections and infestations
Pneumonia
|
0.00%
0/248
|
0.40%
1/251
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.40%
1/248
|
0.00%
0/251
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/248
|
0.40%
1/251
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/248
|
0.80%
2/251
|
|
Nervous system disorders
Cerebrovascular accident
|
0.40%
1/248
|
0.00%
0/251
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/248
|
0.40%
1/251
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/248
|
0.40%
1/251
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/248
|
0.40%
1/251
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.40%
1/248
|
0.00%
0/251
|
Other adverse events
| Measure |
Varenicline
n=248 participants at risk
Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
Placebo
n=251 participants at risk
Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
7/248
|
0.80%
2/251
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.4%
6/248
|
0.00%
0/251
|
|
Gastrointestinal disorders
Constipation
|
4.8%
12/248
|
2.4%
6/251
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
7/248
|
3.6%
9/251
|
|
Gastrointestinal disorders
Dry mouth
|
4.8%
12/248
|
1.6%
4/251
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
9/248
|
0.40%
1/251
|
|
Gastrointestinal disorders
Flatulence
|
7.3%
18/248
|
5.2%
13/251
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.8%
7/248
|
2.0%
5/251
|
|
Gastrointestinal disorders
Nausea
|
27.0%
67/248
|
8.0%
20/251
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
16/248
|
2.4%
6/251
|
|
General disorders
Fatigue
|
4.4%
11/248
|
0.40%
1/251
|
|
General disorders
Irritability
|
2.4%
6/248
|
1.6%
4/251
|
|
Infections and infestations
Bronchitis
|
3.6%
9/248
|
4.4%
11/251
|
|
Infections and infestations
Influenza
|
2.0%
5/248
|
1.2%
3/251
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
10/248
|
4.4%
11/251
|
|
Infections and infestations
Rhinitis
|
2.4%
6/248
|
1.2%
3/251
|
|
Infections and infestations
Sinusitis
|
2.4%
6/248
|
2.0%
5/251
|
|
Infections and infestations
Upper respiratory tract infection
|
8.9%
22/248
|
8.0%
20/251
|
|
Investigations
Weight increased
|
4.4%
11/248
|
0.80%
2/251
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.0%
5/248
|
0.00%
0/251
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.2%
3/248
|
2.0%
5/251
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
6/248
|
2.0%
5/251
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.81%
2/248
|
2.0%
5/251
|
|
Nervous system disorders
Dizziness
|
1.6%
4/248
|
2.8%
7/251
|
|
Nervous system disorders
Dysgeusia
|
2.8%
7/248
|
2.4%
6/251
|
|
Nervous system disorders
Headache
|
8.1%
20/248
|
8.0%
20/251
|
|
Psychiatric disorders
Abnormal dreams
|
10.9%
27/248
|
2.8%
7/251
|
|
Psychiatric disorders
Anxiety
|
2.0%
5/248
|
2.0%
5/251
|
|
Psychiatric disorders
Depression
|
2.0%
5/248
|
1.2%
3/251
|
|
Psychiatric disorders
Insomnia
|
9.7%
24/248
|
6.0%
15/251
|
|
Psychiatric disorders
Nightmare
|
2.0%
5/248
|
0.40%
1/251
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.8%
7/248
|
1.2%
3/251
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
8/248
|
2.8%
7/251
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.0%
5/248
|
0.80%
2/251
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
5/248
|
0.80%
2/251
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER