Pulmonology & Critical Care
PHASE2
● Phase II
Phase 2 Trial: Cytisine and ASA for Inflammation in Lifelong Smokers
ClinicalTrials.gov
Published March 28, 2026
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
NCT03654105 ↗
This Phase 2 prospective randomized pilot trial investigates a comprehensive intervention program targeting lifelong smokers to reduce chronic inflammation. The study, led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, involves 2000 participants and incorporates multiple strategies: smoking cessation with cytisine, low-dose acetylsalicylic acid (ASA) for inflammation, diet modification, increased physical activity, and early lung cancer detection using annual ultra low-dose spiral computed tomography (LDCT). The primary outcome is the change in chronic inflammatory status. The trial began on July 23, 2019, with an estimated primary completion date of December 31, 2024. The study emphasizes the reversibility of risk factors such as tobacco use, poor diet, and physical inactivity, which are major contributors to mortality and morbidity.
AI Accuracy Review: 9/10
· Auto-published
Imagine if making a few lifestyle changes could significantly improve your lung health. This ongoing trial is looking at how quitting smoking, eating better, and increasing physical activity can help reduce chronic inflammation in lifelong smokers. Chronic inflammation can lead to serious health issues, including lung cancer. By using treatments like low-dose acetylsalicylic acid and cytisine to help people quit smoking, along with regular health screenings, the study aims to show that these changes can make a real difference. With 2,000 participants expected, the findings could provide valuable insights into how we can combat the harmful effects of smoking and poor diet on lung health. If successful, this approach could help many people breathe easier and live healthier lives.
What this means for you: Lifestyle changes like quitting smoking and improving diet may reduce lung inflammation and cancer risk.
View Original Abstract ↓
Status: ACTIVE_NOT_RECRUITING | Phase: PHASE2
Condition(s): Inflammation, Smoking Cessation, Diet Modification, Physical Activity, Lung Cancer
Intervention(s): Cytisine (DRUG), Acetylsalicylic acid (DRUG), Diet Modification and Physical Activity Increase (OTHER), early lung cancer detection (DIAGNOSTIC_TEST), spirometry with CO test (DIAGNOSTIC_TEST)
This prospective randomized pilot trial will evaluate a multiple intervention program of prevention in lifelong smokers aiming at reduction of chronic inflammation status through treatment with low-dose acetylsalicylic acid (ASA), smoking cessation with cytisine, targeted modification of diet and physical activity, in addition to early diagnosis with annual ultra low-dose spiral computed tomography (LDCT).
Detailed: 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, legu
Primary Outcome(s): Change in chronic inflammatory status
Enrollment: 2000 (ESTIMATED)
Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Start: 2019-07-23 | Primary Completion: 2024-12-31
