- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03654105
Screening and Multiple Intervention on Lung Epidemics (SMILE)
Multifactorial Intervention of Primary Prevention in High Risk Subjects: a Randomized Trial
Study Overview
Status
Detailed Description
The most recent population-based studies carried out in Europe and the US on hundreds of thousands of individuals have unequivocally identified three principal causes of mortality, morbidity and chronic disability: tobacco smoke, inadequate diet, and reduced physical activity. These risk factors are in large part reversible, because in heavy smokers, even after 60 years of age, cessation is associated with a clear reduction in all-cause mortality. The finding that lifestyle and eating habits are associated with the development of cancer has been confirmed in many studies: smoking, a sedentary lifestyle, excess red meat, processed foods and sugars are associated with increased risk, while an active lifestyle, non-exposure to smoke (both active and passive), consumption of whole grains, legumes and vegetables are associated with protection or a reduced incidence in at-risk subjects.
What is clear, and confirmed by many studies, is that cancer occurs more often in overweight individuals, and that cancer patients who are overweight have more difficulty treating their disease. Elevated plasma levels of C-reactive protein (CRP), even when still within normal limits, are the reflection of a chronic state of inflammation and are associated with poor prognosis in several tobacco-related diseases. CRP measurement is besides a simple test to predict the risk of heart attack and stroke as well as mortality from all causes and from cardiovascular disease. In a systematic review on adult solid tumors, elevated CRP levels were associated with higher mortality and recurrence rates, and this observation was confirmed in early-stage lung cancer by a recent meta-analysis. In patients with chronic obstructive pulmonary disease (COPD), high CRP is a strong and independent predictor of future morbidity and mortality, and an increase in CRP concurrent with a reduction of the forced expiratory volume in 1 second (FEV1) shows an even stronger effect on patient's outcome.
High levels of CRP are associated with poor prognosis in cancers of the upper aerodigestive tract, rhinopharynx, lung and urinary tract. From a dietary point of view, consumption of saturated fats has been directly associated with an increase in inflammatory status as measured by high levels of CRP, just like consumption of meat, while an inverse correlation with consumption of vegetables has been observed. For example, low levels of inflammatory factors have been found in individuals adhering to a Mediterranean diet. Another recurrent finding, at least for cancer, is the importance of daily physical activity, such as brisk walking for 30 minutes. Moreover, regular physical activity is associated with better prognosis and increased survival in patients with a cancer diagnosis.
The number of heavy smokers that will participate in early-diagnosis programs using spiral CT will undoubtedly increase in the future as a result of awareness campaigns, and the participating volunteers represent an excellent opportunity to evaluate the efficacy of targeted primary prevention programs.
The present program will combine several interventions according to the randomization arm, proposed in combination or in single treatment, including treatment with cytisine, reduction of chronic inflammation by treatment with low-dose aspirin (ASA), targeted modification of diet and physical activity, in addition to early diagnosis with annual ultra low-dose spiral computed tomography (LDCT).
At baseline each volunteer will undergo:
- questionnaires on population evaluation (e.g. socio-demographic, smoking habits, physical activity, etc)
- blood sampling for the assessment of the inflammatory and metabolic profile
- evaluation of respiratory function and measurement of carbon monoxide (CO)
- thorax ultra low-dose computed tomography (LDCT) without contrast
- anthropometric evaluation (e.g. weight, height, BMI, etc)
To reduce levels of chronic inflammation will be used:
- treatment with low-dose acetylsalicylic acid (ASA)
- dietary / nutritional intervention in order to promote an optimal diet, based on characteristic of the Mediterranean Diet, for weight maintenance, visceral fat control and an adequate nutritional status
- physical activity intervention, through the reduction of sedentary behaviour and the implementation of a moderate intensity activity of about 30 min a day
In the Smoking cessation will be used Cytisine. It is a molecule known since the early 60s for the treatment of smoking. In recent clinical trials it revealed efficacy in smoking cessation. In 2014, the NHS (National Health Service) produced a document evaluating the cost-effectiveness of drug treatment of smoking, concluding that cytisine has the most favorable profile among the drugs taken into consideration
The imaging will be performed by volumetric acquisition with a computed tomography scanner equipped with advanced technology hardware and software, including: high performance X-ray tube with low potential, high sensitivity detectors combined with dedicated reconstruction algorithms for optimisation of the signal to noise ratio within an ultra low radiation dose. The protocol for ultra-low dose computed tomography will be specifically set for lung cancer screening with semiautomated image analysis and nodule quantification, according to the international standard for image quality (Quantitative Imaging Biomarker Alliance). In particular, the ultra-low dose computed tomography protocol will be developed for the lowest radiation exposure and tested by dedicated phantom for quantitative analysis of imaging metrics.
In the control group subjects will receive an information booklet containing advice on an optimal lifestyle with particular reference to smoking, diet and physical activity according to the best international guidelines.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Milan, Italy, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 55 and 75 years
- High consumption of cigarettes (≥ 30 packs/year)
- Elegibility to annual LDCT screening
- Confidence in Internet use
- Absence of tumors for at least 5 years
- Signed informed consent form
Exclusion Criteria:
- Hypersensitivity to acetylsalicylic acid, salicylates or any of the excipients (excipients: cellulose powder, corn starch, coating: copolymers of methacrylic acid, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate)
- Chronic treatment with acetylsalicylic acid, or other anti-clotting or anti-coagulant drugs (for example: heparin, dicumarol)
- Treatment with methotrexate
- Existing Mastocytosis
- History of asthma induced by the administration of salicylates or substances to similar activity, particularly non-steroidal anti-inflammatory drugs
- Gastroduodenal ulcer
- Hemorrhagic diathesis
- Severe chronic pathology (eg: severe respiratory and / or renal and / or hepatic and / or cardiac insufficiency)
- Serious psychiatric problems
- Previous treatment with Cytisine
- Abuse of alcohol or other substances (even previous)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Smoking cessation and Antinflammatory
Smoking cessation through the administration of Cytisine (in standard and prolonged administration) + reduction of inflammatory status through the administration of Acetylsalicylic acid, diet modification and physical activity increase + standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test
|
Cytisine administration will be randomized 1:1 in standard (40 days)and prolonged treatment (84 days). Subjects will be educated on how to take the product and informed about possible adverse effects.
Other Names:
The treatment will consist of Acetylsalicylic acid at 100mg once a day
Other Names:
It will be proposed:
standard treatment for early lung cancer detection with ultra low dose CT
spirometry with CO test
anthropometic data collection
blood test to assess the metabolic and inflammatory profile
|
Experimental: Smoking cessation
Smoking cessation through the administration of Cytisine (in standard and prolonged administration) + standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test
|
Cytisine administration will be randomized 1:1 in standard (40 days)and prolonged treatment (84 days). Subjects will be educated on how to take the product and informed about possible adverse effects.
Other Names:
standard treatment for early lung cancer detection with ultra low dose CT
spirometry with CO test
anthropometic data collection
blood test to assess the metabolic and inflammatory profile
|
Experimental: Antinflammatory
reduction of inflammatory status through the administration of Acetylsalicylic acid, diet modification and physical activity increase + standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test
|
The treatment will consist of Acetylsalicylic acid at 100mg once a day
Other Names:
It will be proposed:
standard treatment for early lung cancer detection with ultra low dose CT
spirometry with CO test
anthropometic data collection
blood test to assess the metabolic and inflammatory profile
|
Other: Control Group
standard treatment for early lung cancer detection (ultra low dose CT) + spirometry with CO test + anthropometic data collection + blood test
|
standard treatment for early lung cancer detection with ultra low dose CT
spirometry with CO test
anthropometic data collection
blood test to assess the metabolic and inflammatory profile
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in chronic inflammatory status
Time Frame: 1 year
|
Reduction in the percentage of subjects with CRP>=2 mg/L
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in smoking status
Time Frame: 1 year
|
Reduction in the percentage of smokers
|
1 year
|
Change in dietary habits
Time Frame: 1 year
|
Dietary intakes are collected by a self reported food frequencies questionnaire and data are expressed as the average daily/weekly consumption of foods and food groups. Servings size is defined as "natural unit" (e.g. 1 glass of soft drinks, 1 teaspoon of sugar) or as an average serving (e.g. 80 g of pasta or rice, 30 g of dried fruits). The frequency of serving size is reported as continuous measure. Data will be collected as continuous measures and will be analyzed by performing statistical models to investigate a potential relationship among changes in dietary habits and anthropometric parameters (BMI, waist circumference..), socio-demographic characteristics (gender, smoking status, physical activity), biochemical parameters (CRP blood levels), drugs assumption and the risk of chronic diseases, such as lung cancer. |
1 year
|
Change in the physical activity
Time Frame: 1 year
|
Increase in the physical activity measured by the validate short form IPAQ questionnaire (International Physical Activity Questionnaire) The items in the short IPAQ form were structured to provide separate scores on walking, moderate-intensity and vigorous-intensity activity. Computation of the total score requires summation of the duration (in minutes) and frequency (days) of each activity. METs are multiples of the resting metabolic rate and a MET-minute is computed by multiplying the MET score of an activity by the minutes performed:
|
1 year
|
Change in body mass index (BMI)
Time Frame: 1 year
|
Weight and height will be combined to report BMI in kg/m^2.
Reduction in BMI
|
1 year
|
Change in waist circumference
Time Frame: 1 year
|
Reduction in waist circumference expressed in centimeters
|
1 year
|
Change in metabolic profile
Time Frame: 1 year
|
Enhancement in blood glucose, total cholesterol, LDL, HDL and triglycerides
|
1 year
|
Change in lung cancer incidence
Time Frame: 3 years
|
Reduction in lung cancer incidence
|
3 years
|
Change in lung cancer specific and overall mortality
Time Frame: 3 years
|
Reduction in lung cancer specific and overall mortality
|
3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ugo Pastorino, MD, IRCCS IstitutoNazionale dei Tumori di Milano
Publications and helpful links
General Publications
- Global BMI Mortality Collaboration, Di Angelantonio E, Bhupathiraju ShN, Wormser D, Gao P, Kaptoge S, Berrington de Gonzalez A, Cairns BJ, Huxley R, Jackson ChL, Joshy G, Lewington S, Manson JE, Murphy N, Patel AV, Samet JM, Woodward M, Zheng W, Zhou M, Bansal N, Barricarte A, Carter B, Cerhan JR, Smith GD, Fang X, Franco OH, Green J, Halsey J, Hildebrand JS, Jung KJ, Korda RJ, McLerran DF, Moore SC, O'Keeffe LM, Paige E, Ramond A, Reeves GK, Rolland B, Sacerdote C, Sattar N, Sofianopoulou E, Stevens J, Thun M, Ueshima H, Yang L, Yun YD, Willeit P, Banks E, Beral V, Chen Zh, Gapstur SM, Gunter MJ, Hartge P, Jee SH, Lam TH, Peto R, Potter JD, Willett WC, Thompson SG, Danesh J, Hu FB. Body-mass index and all-cause mortality: individual-participant-data meta-analysis of 239 prospective studies in four continents. Lancet. 2016 Aug 20;388(10046):776-86. doi: 10.1016/S0140-6736(16)30175-1. Epub 2016 Jul 13.
- Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.
- Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ. 2004 Jun 26;328(7455):1519. doi: 10.1136/bmj.38142.554479.AE. Epub 2004 Jun 22.
- Pastorino U, Boffi R, Marchiano A, Sestini S, Munarini E, Calareso G, Boeri M, Pelosi G, Sozzi G, Silva M, Sverzellati N, Galeone C, La Vecchia C, Ghirardi A, Corrao G. Stopping Smoking Reduces Mortality in Low-Dose Computed Tomography Screening Participants. J Thorac Oncol. 2016 May;11(5):693-699. doi: 10.1016/j.jtho.2016.02.011. Epub 2016 Feb 24.
- Pastorino U, Morelli D, Marchiano A, Sestini S, Suatoni P, Taverna F, Boeri M, Sozzi G, Cantarutti A, Corrao G. Inflammatory status and lung function predict mortality in lung cancer screening participants. Eur J Cancer Prev. 2018 Jul;27(4):289-295. doi: 10.1097/CEJ.0000000000000342.
- Pastorino U, Morelli D, Leuzzi G, Gisabella M, Suatoni P, Taverna F, Bertocchi E, Boeri M, Sozzi G, Cantarutti A, Corrao G. Baseline and postoperative C-reactive protein levels predict mortality in operable lung cancer. Eur J Cancer. 2017 Jul;79:90-97. doi: 10.1016/j.ejca.2017.03.020. Epub 2017 May 1.
- La Vecchia C, Gallus S, Garattini S. Effects of physical inactivity on non-communicable diseases. Lancet. 2012 Nov 3;380(9853):1553; author reply 1553-4. doi: 10.1016/S0140-6736(12)61872-8. No abstract available.
- Bonaccio M, Cerletti C, Iacoviello L, de Gaetano G. Mediterranean diet and low-grade subclinical inflammation: the Moli-sani study. Endocr Metab Immune Disord Drug Targets. 2015;15(1):18-24. doi: 10.2174/1871530314666141020112146.
- Lee Y, Kang D, Lee SA. Effect of dietary patterns on serum C-reactive protein level. Nutr Metab Cardiovasc Dis. 2014 Sep;24(9):1004-11. doi: 10.1016/j.numecd.2014.05.001. Epub 2014 May 27.
- Bosetti C, Gallus S, Peto R, Negri E, Talamini R, Tavani A, Franceschi S, La Vecchia C. Tobacco smoking, smoking cessation, and cumulative risk of upper aerodigestive tract cancers. Am J Epidemiol. 2008 Feb 15;167(4):468-73. doi: 10.1093/aje/kwm318. Epub 2007 Dec 4.
- Gallus S, Muttarak R, Martinez-Sanchez JM, Zuccaro P, Colombo P, La Vecchia C. Smoking prevalence and smoking attributable mortality in Italy, 2010. Prev Med. 2011 Jun;52(6):434-8. doi: 10.1016/j.ypmed.2011.03.011. Epub 2011 Mar 21.
- Linseisen J, Rohrmann S, Miller AB, Bueno-de-Mesquita HB, Buchner FL, Vineis P, Agudo A, Gram IT, Janson L, Krogh V, Overvad K, Rasmuson T, Schulz M, Pischon T, Kaaks R, Nieters A, Allen NE, Key TJ, Bingham S, Khaw KT, Amiano P, Barricarte A, Martinez C, Navarro C, Quiros R, Clavel-Chapelon F, Boutron-Ruault MC, Touvier M, Peeters PH, Berglund G, Hallmans G, Lund E, Palli D, Panico S, Tumino R, Tjonneland A, Olsen A, Trichopoulou A, Trichopoulos D, Autier P, Boffetta P, Slimani N, Riboli E. Fruit and vegetable consumption and lung cancer risk: updated information from the European Prospective Investigation into Cancer and Nutrition (EPIC). Int J Cancer. 2007 Sep 1;121(5):1103-14. doi: 10.1002/ijc.22807.
- Lugo A, Asciutto R, Pacifici R, Colombo P, La Vecchia C, Gallus S. Smoking in Italy 2013-2014, with a focus on the young. Tumori. 2015 Sep-Oct;101(5):529-34. doi: 10.5301/tj.5000311. Epub 2015 May 15.
- Peto J. Cancer epidemiology in the last century and the next decade. Nature. 2001 May 17;411(6835):390-5. doi: 10.1038/35077256.
- Carter BD, Abnet CC, Feskanich D, Freedman ND, Hartge P, Lewis CE, Ockene JK, Prentice RL, Speizer FE, Thun MJ, Jacobs EJ. Smoking and mortality--beyond established causes. N Engl J Med. 2015 Feb 12;372(7):631-40. doi: 10.1056/NEJMsa1407211.
- Muezzinler A, Mons U, Gellert C, Schottker B, Jansen E, Kee F, O'Doherty MG, Kuulasmaa K, Freedman ND, Abnet CC, Wolk A, Hakansson N, Orsini N, Wilsgaard T, Bueno-de-Mesquita B, van der Schouw YT, Peeters PHM, de Groot LCPGM, Peters A, Orfanos P, Linneberg A, Pisinger C, Tamosiunas A, Baceviciene M, Luksiene D, Bernotiene G, Jousilahti P, Petterson-Kymmer U, Jansson JH, Soderberg S, Eriksson S, Jankovic N, Sanchez MJ, Veronesi G, Sans S, Drygas W, Trichopoulou A, Boffetta P, Brenner H. Smoking and All-cause Mortality in Older Adults: Results From the CHANCES Consortium. Am J Prev Med. 2015 Nov;49(5):e53-e63. doi: 10.1016/j.amepre.2015.04.004. Epub 2015 Jul 15.
- Thun MJ, Carter BD, Feskanich D, Freedman ND, Prentice R, Lopez AD, Hartge P, Gapstur SM. 50-year trends in smoking-related mortality in the United States. N Engl J Med. 2013 Jan 24;368(4):351-64. doi: 10.1056/NEJMsa1211127.
- Peto R, Darby S, Deo H, Silcocks P, Whitley E, Doll R. Smoking, smoking cessation, and lung cancer in the UK since 1950: combination of national statistics with two case-control studies. BMJ. 2000 Aug 5;321(7257):323-9. doi: 10.1136/bmj.321.7257.323.
- Gallus S, La Vecchia C, Levi F, Simonato L, Dal Maso L, Franceschi S. Leanness and squamous cell oesophageal cancer. Ann Oncol. 2001 Jul;12(7):975-9. doi: 10.1023/a:1011104809985.
- Franceschi S, Dal Maso L, Levi F, Conti E, Talamini R, La Vecchia C. Leanness as early marker of cancer of the oral cavity and pharynx. Ann Oncol. 2001 Mar;12(3):331-6. doi: 10.1023/a:1011191809335.
- Duan P, Hu C, Quan C, Yi X, Zhou W, Yuan M, Yu T, Kourouma A, Yang K. Body mass index and risk of lung cancer: Systematic review and dose-response meta-analysis. Sci Rep. 2015 Nov 19;5:16938. doi: 10.1038/srep16938.
- Kabat GC, Kim M, Hunt JR, Chlebowski RT, Rohan TE. Body mass index and waist circumference in relation to lung cancer risk in the Women's Health Initiative. Am J Epidemiol. 2008 Jul 15;168(2):158-69. doi: 10.1093/aje/kwn109. Epub 2008 May 15.
- Lam TK, Moore SC, Brinton LA, Smith L, Hollenbeck AR, Gierach GL, Freedman ND. Anthropometric measures and physical activity and the risk of lung cancer in never-smokers: a prospective cohort study. PLoS One. 2013 Aug 5;8(8):e70672. doi: 10.1371/journal.pone.0070672. Print 2013.
- Etemadi A, O'Doherty MG, Freedman ND, Hollenbeck AR, Dawsey SM, Abnet CC. A prospective cohort study of body size and risk of head and neck cancers in the NIH-AARP diet and health study. Cancer Epidemiol Biomarkers Prev. 2014 Nov;23(11):2422-9. doi: 10.1158/1055-9965.EPI-14-0709-T. Epub 2014 Aug 29.
- Gaudet MM, Kitahara CM, Newton CC, Bernstein L, Reynolds P, Weiderpass E, Kreimer AR, Yang G, Adami HO, Alavanja MC, Beane Freeman LE, Boeing H, Buring J, Chaturvedi A, Chen Y, D'Aloisio AA, Freedman M, Gao YT, Gaziano JM, Giles GG, Hakansson N, Huang WY, Lee IM, Linet MS, MacInnis RJ, Park Y, Prizment A, Purdue MP, Riboli E, Robien K, Sandler DP, Schairer C, Sesso HD, Ou Shu X, White E, Wolk A, Xiang YB, Zelenuich-Jacquotte A, Zheng W, Patel AV, Hartge P, Berrington de Gonzalez A, Gapstur SM. Anthropometry and head and neck cancer:a pooled analysis of cohort data. Int J Epidemiol. 2015 Apr;44(2):673-81. doi: 10.1093/ije/dyv059. Epub 2015 Jun 6.
- Anandavadivelan P, Lagergren P. Cachexia in patients with oesophageal cancer. Nat Rev Clin Oncol. 2016 Mar;13(3):185-98. doi: 10.1038/nrclinonc.2015.200. Epub 2015 Nov 17.
- Andersson BA, Lewin F, Lundgren J, Nilsson M, Rutqvist LE, Lofgren S, Laytragoon-Lewin N. Plasma tumor necrosis factor-alpha and C-reactive protein as biomarker for survival in head and neck squamous cell carcinoma. J Cancer Res Clin Oncol. 2014 Mar;140(3):515-9. doi: 10.1007/s00432-014-1592-8. Epub 2014 Jan 31.
- Xia WX, Ye YF, Lu X, Wang L, Ke LR, Zhang HB, Roycik MD, Yang J, Shi JL, Cao KJ, Guo X, Xiang YQ. The impact of baseline serum C-reactive protein and C-reactive protein kinetics on the prognosis of metastatic nasopharyngeal carcinoma patients treated with palliative chemotherapy. PLoS One. 2013 Oct 10;8(10):e76958. doi: 10.1371/journal.pone.0076958. eCollection 2013.
- Hong S, Kang YA, Cho BC, Kim DJ. Elevated serum C-reactive protein as a prognostic marker in small cell lung cancer. Yonsei Med J. 2012 Jan;53(1):111-7. doi: 10.3349/ymj.2012.53.1.111.
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- Santos S, Oliveira A, Lopes C. Systematic review of saturated fatty acids on inflammation and circulating levels of adipokines. Nutr Res. 2013 Sep;33(9):687-95. doi: 10.1016/j.nutres.2013.07.002. Epub 2013 Aug 6.
- Trichopoulou A, Kouris-Blazos A, Wahlqvist ML, Gnardellis C, Lagiou P, Polychronopoulos E, Vassilakou T, Lipworth L, Trichopoulos D. Diet and overall survival in elderly people. BMJ. 1995 Dec 2;311(7018):1457-60. doi: 10.1136/bmj.311.7018.1457.
- Montgomery AA, Peters TJ, Little P. Design, analysis and presentation of factorial randomised controlled trials. BMC Med Res Methodol. 2003 Nov 24;3:26. doi: 10.1186/1471-2288-3-26.
- Pastorino U, Bellomi M, Landoni C, De Fiori E, Arnaldi P, Picchio M, Pelosi G, Boyle P, Fazio F. Early lung-cancer detection with spiral CT and positron emission tomography in heavy smokers: 2-year results. Lancet. 2003 Aug 23;362(9384):593-7. doi: 10.1016/S0140-6736(03)14188-8.
- West R, Zatonski W, Cedzynska M, Lewandowska D, Pazik J, Aveyard P, Stapleton J. Placebo-controlled trial of cytisine for smoking cessation. N Engl J Med. 2011 Sep 29;365(13):1193-200. doi: 10.1056/NEJMoa1102035.
- Walker N, Howe C, Glover M, McRobbie H, Barnes J, Nosa V, Parag V, Bassett B, Bullen C. Cytisine versus nicotine for smoking cessation. N Engl J Med. 2014 Dec 18;371(25):2353-62. doi: 10.1056/NEJMoa1407764.
- Walker N, Bullen C, Barnes J, McRobbie H, Tutka P, Raw M, Etter JF, Siddiqi K, Courtney RJ, Castaldelli-Maia JM, Selby P, Sheridan J, Rigotti NA. Getting cytisine licensed for use world-wide: a call to action. Addiction. 2016 Nov;111(11):1895-1898. doi: 10.1111/add.13464. Epub 2016 Jul 17. No abstract available.
Helpful Links
- World Cancer Research Fund / American Institute for Cancer Research. Food, Nutrition, Physical Activity, and the Prevention of Cancer: a Global Perspective
- WHO report on the global tobacco epidemic, 2015
- AIRC. Fumo: le domande più frequenti. Perché si insiste tanto sui rischi del fumo?
- Detels R, Gulliford M, Karim QA, Tan CC. Oxford Textbook of Global Public Health (6 ed.)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Inflammation
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
Other Study ID Numbers
- 2016-003036-20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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