E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The IMP will assist smoking cessation in smokers wishing to stop. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess six month prolonged abstinence from smoking in all participants, measured by the Russell standard criteria ('abstinence' is defined as smoking fewer than 5 cigarettes following a quit date and biochemically confirmed by an exhaled CO of <10 parts per million). |
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E.2.2 | Secondary objectives of the trial |
To assess the no. of participants smoking at four weeks and 12 months after quit day using self report only, not biologically confirmed. To assess no. of participants at 4 weeks, 6 and 12 months who have not been smoking for the previous 7 days. To collect data on the side-effects of NRT patch use and symptoms of nicotine overdose (such as nausea, excessive salivation) at each contact. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Smokers aged ≥ 18 years of age (assessed on telephone screening) • Smokers who, in the judgement of the clinician, would be suitable for preloading (assessed on telephone screening and in clinic). • Those seeking NHS support to stop smoking (assessed on telephone screening) and willing to quit in 4 weeks • Those able and willing to comply with study procedures (assessed on telephone screening). |
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E.4 | Principal exclusion criteria |
• Those who are pregnant or breastfeeding (assessed on telephone screening) • Those with extensive dermatitis/other skin disorder that precludes patch use (assessed on telephone and clinic screening) • Those with acute coronary syndrome or stroke within the past three weeks (assessed on telephone screening) • Those with active phaeocromocytoma and uncontrolled hyperthyroidism (assessed on telephone screening) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Six month prolonged abstinence, measured by the Russell standard criteria i.e. a grace period of 2 weeks, followed by smoking fewer than 5 cigarettes thereafter and biochemically confirmed by an exhaled Carbon monoxide (CO) reading of less than 10 parts per million. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Four week and 12 month abstinence and 7-day point prevalence biochemically confirmed abstinence at 4 weeks, 6 and 12 months according to the Russell Standard (validated CO must be less than 10 parts per million). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
4 weeks, 6 and 12 months after quit day. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
There is no placebo. The comparator will be standard care. |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined shortly after the date of last follow up, once all data has been collected and as soon as database lock has taken place. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 30 |