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Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial

Philip Tønnesen, Hans Lauri, Roland Perfekt, Karl Mann, Anil Batra
European Respiratory Journal 2012 40: 548-554; DOI: 10.1183/09031936.00155811
Philip Tønnesen
*Dept of Pulmonary Medicine, Gentofte University Hospital, Copenhagen, Denmark
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Hans Lauri
#Global Medical Affairs and Clinical Research, McNeil AB, Helsingborg, Sweden
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Roland Perfekt
#Global Medical Affairs and Clinical Research, McNeil AB, Helsingborg, Sweden
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Karl Mann
¶Dept of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, University of Heidelberg
§Both authors contributed equally
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Anil Batra
+Dept of Psychiatry and Psychotherapy, Section for Addiction Medicine and Research, University Hospital of Tübingen, Germany
§Both authors contributed equally
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Figures

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  • Figure 1–
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    Figure 1–

    Flow diagram of the progress of subjects through the phases of the study.

  • Figure 2–
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    Figure 2–

    Proportion of subjects with carbon monoxide-verified 7-day point prevalence of abstinence. Includes all subjects (nicotine mouth spray (NMS): n=318; placebo: n=161). *: p<0.05 between the abstinence rates in the NMS group compared with the placebo group.

  • Figure 3–
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    Figure 3–

    Median of the individual mean daily number of spray doses by study week (weeks 1 to 12) in subjects in the nicotine mouth spray (NMS) group. Sprays/all: all NMS subjects reporting data for at least 50% of the days in that specific period; Sprays/abst: all NMS subjects with verified 7-day point prevalence abstinence reporting data for at least 50% of the days in that specific period.

Tables

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  • Table 1– Inclusion and exclusion criteria
    Inclusion criteriaExclusion criteria
    Males and females, 18 yrs or older
    Daily cigarette smoker for the last 3 yrs or more (no lower limit in number of daily cigarettes)
    Expired carbon monoxide level of at least 10 ppm after at least 15 smoke-free min
    Motivated and willing to completely stop smoking from the day after the baseline visit and to stay smoke-free
    Willing to use study drug for at least 12 weeks
    Female participants of child-bearing potential to use a medically acceptable method of birth control
    Evidence of a personally signed and dated informed consent document
    Willing and able to comply with all study procedures and attend 11 scheduled visits during the 52-week study
    Willing and able to use an eDiary, according to the instructions provided, and willing to return the eDiary at the 12-week visit
    Current use of tobacco-containing products, other than cigarettes, or smoking other substances
    Use of other NRT, or bupropion or varenicline, or any other treatment for tobacco dependence (e.g. acupuncture)
    Unstable angina pectoris or myocardial infarction or stroke during the previous 3 months
    Pregnancy, lactation or intended pregnancy
    Suspected alcohol or drug abuse
    Another member of the same household who is already a subject in the current trial
    Participation in any other clinical trial within the previous 3 months, or during the current trial
    Any acute or chronic medical or psychiatric condition or previously diagnosed renal or hepatic disease that may increase the risk associated with study participation
    Presence of an oral lesion (suspected malignant lesion and/or erosive lesion) that required further investigation, such as biopsy
    • The text for inclusion and exclusion criteria is appropriately abbreviated. NRT: nicotine replacement therapy.

  • Table 2– Treatment-related adverse events: overview and numbers of subjects reporting (by preferred term)
    Nicotine mouth sprayPlacebo
    Subjects n318161
    Subjects with at least one adverse event#278 (87.4)115 (71.4)
    Subjects discontinued because of an adverse event25 (7.9)11 (6.8)
    Adverse events (preferred term) reported by ≥10% of subjects in either treatment group
     Hiccups182 (57.2)12 (7.5)
     Throat irritation126 (39.6)45 (28.0)
     Headache103 (32.4)58 (36.0)
     Nausea101 (31.8)39 (24.2)
     Dyspepsia93 (29.2)24 (14.9)
     Stomatitis75 (23.6)27 (16.8)
     Salivary hypersecretion68 (21.4)19 (11.8)
     Dizziness61 (19.2)39 (24.2)
     Constipation60 (18.9)28 (17.4)
     Dry mouth44 (13.8)24 (14.9)
     Dysgeusia38 (11.9)20 (12.4)
     Burning sensation in mouth38 (11.9)13 (8.1)
    • Data are presented as n (%), unless otherwise stated. #: adverse events reported by number of subjects in either treatment group who reported a treatment-related adverse event at least once. “Treatment related” was captured in the case report forms as the answer “Yes/Unknown” to the question “Is there a reasonable possibility the adverse event is related to study treatment?” All the preferred terms in the table above were included as a "health problem" prompt in the eDiary. The “health problem” prompt consisted of a checklist of 14 predefined adverse events (the 12 listed above, plus common cold and vomiting) and an “Other” option. The preferred terms dyspepsia, stomatitis, salivary hypersecretion, dysgeusia, and burning sensation in the mouth were elicited using the following adverse event prompts in the eDiary: heartburn, mouth irritation, excessive salivation, altered taste, and burning lips, respectively.

  • Table 3– Baseline demographic characteristics and smoking history
    Nicotine mouth sprayPlacebo
    Subjects n318161
    Age yrs47.0±10.946.2±11.3
    Sex female137 (43.1)73 (45.3)
    Smoking history
    –Cigarettes per day22.7±8.822.7±8.7
    –Expired CO level ppm26.4±10.126.6±11.3
    –Saliva cotinine ng·mL−1356±154 (n=316)349±151 (n=159)
    –Age started smoking yrs16.6±3.6 (n=317)16.5±3.6 (n=161)
    –Never tried to quit before37 (11.6)26 (16.1)
    –0–3 months since last quit attempt63 (19.8)28 (17.4)
    –Previously used stop-smoking medication(s)171 (53.8)84 (52.8) (n=159)
    –Previously used NRT150 (47.2)79 (49.1)
    FTND score5.3±2.35.4±2.2
    Time to first cigarette
    –Within 5 min of waking94 (29.6)49 (30.4)
    –6–30 min after waking139 (43.7)76 (47.2)
    –31–60 min after waking49 (15.4)20 (12.4)
    –>60 min after waking36 (11.3)16 (9.9)
    Blood pressure mmHg133±18/85±12 (n=313)132±18/84±11 (n=158)
    Body mass index kg·m−226.3±5.3 (n=313)26.0±5.1 (n=160)
    • Data are presented as mean±sd or n (%), unless otherwise stated. CO: carbon monoxide; NRT: nicotine replacement therapy; FTND: Fagerström Test of Nicotine Dependence.

  • Table 4– Carbon monoxide-verified continuous abstinence rates from week 2 to weeks 4, 6, 8, 12, 16, 20, 24 and 52
    Time pointNicotine mouth spray#Placebo¶p-value+Risk ratio (95% CI)§Odds ratio (95% CI)§
    Week 4101 (31.8)35 (21.7)0.0221.46 (1.05–2.04)1.68 (1.08–2.61)
    Week 683 (26.1)26 (16.1)0.0141.62 (1.09–2.41)1.83 (1.13–2.99)
    Week 878 (24.5)23 (14.3)0.0091.72 (1.12–2.63)1.95 (1.17–3.25)
    Week1264 (20.1)21 (13.0)0.0551.54 (0.98–2.43)1.68 (0.98–2.87)
    Week 1657 (17.9)15 (9.3)0.0131.92 (1.13–3.29)2.13 (1.16–3.89)
    Week 2053 (16.7)11 (6.8)0.0032.44 (1.31–4.54)2.73 (1.38–5.38)
    Week 2450 (15.7)11 (6.8)0.0062.30 (1.23–4.30)2.54 (1.29–5.04)
    Week 5244 (13.8)9 (5.6)0.0072.48 (1.24–4.94)2.71 (1.29–5.71)
    • Values are presented as n (%), unless otherwise stated. #: n=318; ¶: n=161; +: p-values were calculated using the Chi-squared test; §: estimated risk ratios/odds ratios and corresponding 95% confidence intervals were calculated using Mantel–Haenszel statistics.

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Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial
Philip Tønnesen, Hans Lauri, Roland Perfekt, Karl Mann, Anil Batra
European Respiratory Journal Sep 2012, 40 (3) 548-554; DOI: 10.1183/09031936.00155811

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Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial
Philip Tønnesen, Hans Lauri, Roland Perfekt, Karl Mann, Anil Batra
European Respiratory Journal Sep 2012, 40 (3) 548-554; DOI: 10.1183/09031936.00155811
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