Clinical Trial

Screening and Multiple Intervention on Lung Epidemics

Study acronym: SMILE
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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).
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2018-08-29; most recent amendment 2026-03-26.
Status change: Recruiting → Active, Not Recruiting 2021-02-12
Status change: Not Yet Recruiting → Recruiting 2019-08-06
Trial Details
NCT Number NCT03654105
Lead Sponsor Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators: Istituto Di Ricerche Farmacologiche Mario Negri
Conditions Inflammation, Smoking Cessation, Diet Modification, Physical Activity, Lung Cancer
Enrollment 2,000 participants
Start Date 2019-07-23
Primary Completion 2024-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-27