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    Clinical Trial Results:
    Comparison of the effects of the electronic cigarette and nicotine inhalator on tobacco withdrawal symptoms over 24 hours of abstinence

    Summary
    EudraCT number
    		 2011-005565-20
    Trial protocol
    		 GB  
    Global end of trial date
    21 Feb 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2017
    First version publication date
    29 Jul 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    QMUL111111
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01454362
    WHO universal trial number (UTN)
    		 U1111-1127-4445
    Other trial identifiers
    		 Reda Ref: 008261
    Sponsors
    Sponsor organisation name
    Queen Mary University of London
    Sponsor organisation address
    5 Walden Street, London, United Kingdom, E1 2EF
    Public contact
    The Joint Research Office , QUEEN MARY, UNIVERSITY OF LONDON, 0207 882 7260, researchamendments@bartsandthelondon.nhs.uk
    Scientific contact
    The Joint Research Office , QUEEN MARY, UNIVERSITY OF LONDON, 0207 882 7260, researchamendments@bartsandthelondon.nhs.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Feb 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to investigate whether the E-C is more effective at alleviating withdrawal symptoms than the nicotine inhalator during 24hr abstinence.
    Protection of trial subjects
    Participants were screened and consented by a medical doctor and completed a health problems checklist after product use.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jan 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 51
    Worldwide total number of subjects
    51
    EEA total number of subjects
    51
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    48
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited at the Tobacco Dependence Research Unit in London between January 2013 and February 2013.

    Pre-assignment
    Screening details
    		 Inclusion Criteria Smoking at least 12 cigarettes per day; first cigarette smoked within 60 mins of waking; willing to abstain from smoking for one day in 2 consecutive weeks. Exclusion Criteria Under 18s; current psychiatric illness; planning pregnancy, pregnant or breastfeeding; enrolled in other research, used EC or inhaler before.

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 E-cigarette
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    E-cigarette
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Oral use
    Dosage and administration details
    As needed

    Arm title
    		 Inhalator
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nicorette Inhalator
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Oral use
    Dosage and administration details
    As needed.

    Number of subjects in period 1
    		E-cigarette Inhalator
    Started
    51
    51
    Completed
    51
    51

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 51 51
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 48 48
        From 65-84 years
    		 3 3
        85 years and over
    		 0 0
        Age 18+
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 42 42

    End points

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    End points reporting groups
    Reporting group title
    E-cigarette
    Reporting group description
    		 -

    Reporting group title
    Inhalator
    Reporting group description
    		 -

    Primary: Mean withdrawal rating at 24 hours

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    End point title
    		 Mean withdrawal rating at 24 hours
    End point description
    Mean withdrawal rating at 24 hours
    End point type
    Primary
    End point timeframe
    24 hours
    End point values
    		 E-cigarette Inhalator
    Number of subjects analysed
    51 [1]
    51 [2]
    Units: withdrawal rating
        arithmetic mean (standard deviation)
    0.73 ( 0.64 )
    0.86 ( 0.73 )
    Notes
    [1] - Study was randomised crossover trial
    [2] - Study was a randomised crossover trial
    Statistical analysis title
    		 Comparison of mean withdrawal ratings at 24h
    Comparison groups
    Inhalator v E-cigarette
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.17
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Mean urge to smoke at 24 hours

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    End point title
    		 Mean urge to smoke at 24 hours
    End point description
    Mean urge to smoke at 24 hours
    End point type
    Primary
    End point timeframe
    24 hours
    End point values
    		 E-cigarette Inhalator
    Number of subjects analysed
    51
    51
    Units: urge rating
        arithmetic mean (standard deviation)
    1.84 ( 0.91 )
    2.28 ( 0.9 )
    Statistical analysis title
    		 Comparison of mean urge to smoke at 24 hours
    Comparison groups
    E-cigarette v Inhalator
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Mean change in salivary cotinine ng/ml

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    End point title
    		 Mean change in salivary cotinine ng/ml
    End point description
    Mean change in salivary cotinine
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 E-cigarette Inhalator
    Number of subjects analysed
    49
    49
    Units: change in salivary cotinine
        arithmetic mean (standard deviation)
    -66.32 ( 94.84 )
    -53.8 ( 119.4 )
    Statistical analysis title
    		 Comparison of mean change in salivary cotinine ng/
    Comparison groups
    E-cigarette v Inhalator
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.43
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Mean satisfaction from product when compared to cigarettes (rating 0-4)

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    End point title
    		 Mean satisfaction from product when compared to cigarettes (rating 0-4)
    End point description
    Mean satisfaction from product when compared to cigarettes (rating 0-4)
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 E-cigarette Inhalator
    Number of subjects analysed
    51
    51
    Units: satisfaction rating
        arithmetic mean (standard deviation)
    1.18 ( 1.05 )
    0.59 ( 1.1 )
    Statistical analysis title
    		 Comparison of mean satisfaction from product
    Comparison groups
    E-cigarette v Inhalator
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Mean pleasant feeling from using the product (rating 0-4)

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    End point title
    		 Mean pleasant feeling from using the product (rating 0-4)
    End point description
    Mean pleasant feeling from using the product (rating 0-4)
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 E-cigarette Inhalator
    Number of subjects analysed
    51
    51
    Units: pleasantness rating
        arithmetic mean (standard deviation)
    2 ( 1.11 )
    0.67 ( 0.89 )
    Statistical analysis title
    		 Comparions of Mean pleasant feeling
    Comparison groups
    E-cigarette v Inhalator
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Mean enjoyment of the sensation in the throat and chest (rating 0-4)

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    End point title
    		 Mean enjoyment of the sensation in the throat and chest (rating 0-4)
    End point description
    Mean enjoyment of the sensation in the throat and chest (rating 0-4)
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 E-cigarette Inhalator
    Number of subjects analysed
    51
    51
    Units: enjoyment rating
        arithmetic mean (standard deviation)
    1.65 ( 1.05 )
    0.51 ( 0.7 )
    Statistical analysis title
    		 Comparison of Mean enjoyment of the sensation
    Comparison groups
    E-cigarette v Inhalator
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Mean helpfulness of the product enabling the participant to keep from smoking (rating 0-4)

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    End point title
    		 Mean helpfulness of the product enabling the participant to keep from smoking (rating 0-4)
    End point description
    Mean helpfulness of the product enabling the participant to keep from smoking (rating 0-4)
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 E-cigarette Inhalator
    Number of subjects analysed
    51
    51
    Units: helpfulness rating
        arithmetic mean (standard deviation)
    2.61 ( 1.08 )
    1.69 ( 1.03 )
    Statistical analysis title
    		 Comparison of mean helpfulness of the product
    Comparison groups
    E-cigarette v Inhalator
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Mean embarrassment of using the products in company (rating 0-4)

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    End point title
    		 Mean embarrassment of using the products in company (rating 0-4)
    End point description
    Mean embarrassment of using the products in company (rating 0-4)
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 E-cigarette Inhalator
    Number of subjects analysed
    51
    51
    Units: embarrassment rating
        arithmetic mean (standard deviation)
    0.75 ( 0.98 )
    0.65 ( 0.98 )
    Statistical analysis title
    		 Comparison of mean embarrassment
    Comparison groups
    E-cigarette v Inhalator
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.53
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Mean use of the products as a stop smoking aid, SSA (rating 0-4)

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    End point title
    		 Mean use of the products as a stop smoking aid, SSA (rating 0-4)
    End point description
    Mean use of the products as a stop smoking aid (rating 0-4)
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 E-cigarette Inhalator
    Number of subjects analysed
    51
    51
    Units: rating of product as stop smoking aid
        arithmetic mean (standard deviation)
    3.16 ( 1.05 )
    1.57 ( 1.2 )
    Statistical analysis title
    		 Comparison of mean use of the products as a SSA
    Comparison groups
    E-cigarette v Inhalator
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Mean recommend the products to a friend who wants to quit smoking (rating 0-4)

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    End point title
    		 Mean recommend the products to a friend who wants to quit smoking (rating 0-4)
    End point description
    Mean recommend the products to a friend who wants to quit smoking (rating 0-4)
    End point type
    Secondary
    End point timeframe
    24 hours
    End point values
    		 E-cigarette Inhalator
    Number of subjects analysed
    51
    51
    Units: recommendation rating
        arithmetic mean (standard deviation)
    3.2 ( 1.1 )
    1.9 ( 1.2 )
    Statistical analysis title
    		 Comparison of mean recommend the products
    Comparison groups
    E-cigarette v Inhalator
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 hours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    E-cigarette AEs
    Reporting group description
    		 -

    Reporting group title
    Inhalator AEs
    Reporting group description
    		 -

    Serious adverse events
    		 E-cigarette AEs Inhalator AEs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 E-cigarette AEs Inhalator AEs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 51 (58.82%)
    34 / 51 (66.67%)
    Cardiac disorders
    Dyspnoea
         subjects affected / exposed
    8 / 51 (15.69%)
    6 / 51 (11.76%)
         occurrences all number
    8
    6
    Dyspnoea at rest
         subjects affected / exposed
    5 / 51 (9.80%)
    2 / 51 (3.92%)
         occurrences all number
    5
    2
    Chest pain
         subjects affected / exposed
    6 / 51 (11.76%)
    4 / 51 (7.84%)
         occurrences all number
    6
    4
    Chest discomfort
         subjects affected / exposed
    7 / 51 (13.73%)
    3 / 51 (5.88%)
         occurrences all number
    7
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    9 / 51 (17.65%)
    9 / 51 (17.65%)
         occurrences all number
    9
    9
    Headache
         subjects affected / exposed
    10 / 51 (19.61%)
    9 / 51 (17.65%)
         occurrences all number
    10
    9
    Sleep disturbance
         subjects affected / exposed
    7 / 51 (13.73%)
    5 / 51 (9.80%)
         occurrences all number
    7
    5
    Eye disorders
    Visual impairment
         subjects affected / exposed
    4 / 51 (7.84%)
    2 / 51 (3.92%)
         occurrences all number
    4
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 51 (13.73%)
    11 / 51 (21.57%)
         occurrences all number
    7
    11
    Respiratory, thoracic and mediastinal disorders
    Wheezing
         subjects affected / exposed
    7 / 51 (13.73%)
    8 / 51 (15.69%)
         occurrences all number
    7
    8
    Cough
         subjects affected / exposed
    14 / 51 (27.45%)
    18 / 51 (35.29%)
         occurrences all number
    14
    18
    Productive cough
         subjects affected / exposed
    12 / 51 (23.53%)
    9 / 51 (17.65%)
         occurrences all number
    12
    9
    Psychiatric disorders
    Disturbance in attention
         subjects affected / exposed
    9 / 51 (17.65%)
    15 / 51 (29.41%)
         occurrences all number
    9
    15

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Aug 2012
    Change to PI.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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