Screening and Multiple Intervention on Lung Epidemics

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Collaborator: Istituto Di Ricerche Farmacologiche Mario Negri
• Treatments: Aspirin

Criteria

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)