Clinical Trial Results:
Comparison of the effects of the electronic cigarette and nicotine inhalator on tobacco withdrawal symptoms over 24 hours of abstinence
Summary
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EudraCT number |
2011-005565-20 |
Trial protocol |
GB |
Global end of trial date |
21 Feb 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jul 2017
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First version publication date |
29 Jul 2017
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
QMUL111111
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01454362 | ||
WHO universal trial number (UTN) |
U1111-1127-4445 | ||
Other trial identifiers |
Reda Ref: 008261 | ||
Sponsors
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Sponsor organisation name |
Queen Mary University of London
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Sponsor organisation address |
5 Walden Street, London, United Kingdom, E1 2EF
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Public contact |
The Joint Research Office , QUEEN MARY, UNIVERSITY OF LONDON, 0207 882 7260, researchamendments@bartsandthelondon.nhs.uk
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Scientific contact |
The Joint Research Office , QUEEN MARY, UNIVERSITY OF LONDON, 0207 882 7260, researchamendments@bartsandthelondon.nhs.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 May 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
21 Feb 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Feb 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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Protection of trial subjects |
Participants were screened and consented by a medical doctor and completed a health problems checklist after product use.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Jan 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 51
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Worldwide total number of subjects |
51
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EEA total number of subjects |
51
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
48
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants were recruited at the Tobacco Dependence Research Unit in London between January 2013 and February 2013. | |||||||||
Pre-assignment
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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
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Period 1 title |
Baseline (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
Not applicable
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Arms
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Are arms mutually exclusive |
No
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Arm title
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E-cigarette | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
E-cigarette
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation solution
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Routes of administration |
Oral use
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Dosage and administration details |
As needed
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Arm title
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Inhalator | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Nicorette Inhalator
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation vapour
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Routes of administration |
Oral use
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Dosage and administration details |
As needed.
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Baseline characteristics reporting groups
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Reporting group title |
Baseline
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
E-cigarette
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Reporting group description |
- | ||
Reporting group title |
Inhalator
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Reporting group description |
- |
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End point title |
Mean withdrawal rating at 24 hours | ||||||||||||
End point description |
Mean withdrawal rating at 24 hours
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End point type |
Primary
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End point timeframe |
24 hours
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Notes [1] - Study was randomised crossover trial [2] - Study was a randomised crossover trial |
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Statistical analysis title |
Comparison of mean withdrawal ratings at 24h | ||||||||||||
Comparison groups |
Inhalator v E-cigarette
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Number of subjects included in analysis |
102
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.17 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Mean urge to smoke at 24 hours | ||||||||||||
End point description |
Mean urge to smoke at 24 hours
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End point type |
Primary
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End point timeframe |
24 hours
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Statistical analysis title |
Comparison of mean urge to smoke at 24 hours | ||||||||||||
Comparison groups |
E-cigarette v Inhalator
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Number of subjects included in analysis |
102
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.005 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Mean change in salivary cotinine ng/ml | ||||||||||||
End point description |
Mean change in salivary cotinine
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End point type |
Secondary
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End point timeframe |
24 hours
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Statistical analysis title |
Comparison of mean change in salivary cotinine ng/ | ||||||||||||
Comparison groups |
E-cigarette v Inhalator
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Number of subjects included in analysis |
98
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.43 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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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)
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End point type |
Secondary
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End point timeframe |
24 hours
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Statistical analysis title |
Comparison of mean satisfaction from product | ||||||||||||
Comparison groups |
E-cigarette v Inhalator
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Number of subjects included in analysis |
102
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.003 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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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)
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End point type |
Secondary
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End point timeframe |
24 hours
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Statistical analysis title |
Comparions of Mean pleasant feeling | ||||||||||||
Comparison groups |
E-cigarette v Inhalator
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Number of subjects included in analysis |
102
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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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)
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End point type |
Secondary
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End point timeframe |
24 hours
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Statistical analysis title |
Comparison of Mean enjoyment of the sensation | ||||||||||||
Comparison groups |
E-cigarette v Inhalator
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Number of subjects included in analysis |
102
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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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)
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End point type |
Secondary
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End point timeframe |
24 hours
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Statistical analysis title |
Comparison of mean helpfulness of the product | ||||||||||||
Comparison groups |
E-cigarette v Inhalator
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Number of subjects included in analysis |
102
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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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)
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End point type |
Secondary
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End point timeframe |
24 hours
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Statistical analysis title |
Comparison of mean embarrassment | ||||||||||||
Comparison groups |
E-cigarette v Inhalator
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Number of subjects included in analysis |
102
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.53 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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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)
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End point type |
Secondary
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End point timeframe |
24 hours
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Statistical analysis title |
Comparison of mean use of the products as a SSA | ||||||||||||
Comparison groups |
E-cigarette v Inhalator
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Number of subjects included in analysis |
102
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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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)
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End point type |
Secondary
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End point timeframe |
24 hours
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Statistical analysis title |
Comparison of mean recommend the products | ||||||||||||
Comparison groups |
E-cigarette v Inhalator
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Number of subjects included in analysis |
102
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
24 hours
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.0
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Reporting groups
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Reporting group title |
E-cigarette AEs
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Inhalator AEs
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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23 Aug 2012 |
Change to PI. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |