Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial
A nicotine mouth spray has advantages over other acute forms of nicotine replacement therapy, such as a faster uptake of nicotine and faster relief of craving. This multicentre, randomised (2:1), double-blind, placebo-controlled efficacy and safety study evaluated self-reported, carbon monoxide-veri...
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| Hauptverfasser: | , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
August 31,2012
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| In: |
The European respiratory journal
Year: 2012, Jahrgang: 40, Heft: 3, Pages: 548-554 |
| ISSN: | 1399-3003 |
| DOI: | 10.1183/09031936.00155811 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1183/09031936.00155811 Verlag, kostenfrei, Volltext: http://erj.ersjournals.com/content/40/3/548 
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| Verfasserangaben: | Philip Tønnesen, Hans Lauri, Roland Perfekt, Karl Mann and Anil Batra |
MARC
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| 520 | |a A nicotine mouth spray has advantages over other acute forms of nicotine replacement therapy, such as a faster uptake of nicotine and faster relief of craving. This multicentre, randomised (2:1), double-blind, placebo-controlled efficacy and safety study evaluated self-reported, carbon monoxide-verified continuous abstinence from smoking from week 2 until weeks 6, 24, and 52 in 479 smokers (≥1 cigarette per day) who were treated with either active (n=318) or placebo (n=161) spray for 12 weeks and low-intensity counselling at three smoking cessation clinics in Denmark and Germany. Active treatment yielded significantly higher continuous abstinence rates than placebo from week 2 until week 6 (26.1% versus 16.1%; relative success rate (RR) 1.62, 95% CI 1.09-2.41), week 24 (15.7% versus 6.8%; RR 2.30, 95% CI 1.23-4.30), and week 52 (13.8% versus 5.6%; RR 2.48, 95% CI 1.24-4.94). Most adverse events were mild to moderate, and 9.1% of subjects on active spray withdrew due to adverse events, compared to 7.5% on placebo. The overall rate of treatment-related adverse events was 87.4% with active spray versus 71.4% with placebo spray. Nicotine mouth spray delivered significantly higher 6-, 24- and 52-week continuous abstinence rates than placebo. | ||
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