TOBacco STOP in Chronic Obstructive Pulmonary Disease-Trial - Study Protocol

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Background:

Cigarette smoking is the leading cause of chronic obstructive pulmonary disease (COPD) and it contributes to the development of many other serious diseases. Acute exacerbations of COPD (AECOPD) often lead to hospitalization. Severe hospitalization-requiring AECOPD carries very high economic costs for the healthcare system, and personal costs for patients. Smoking cessation in COPD for the healthcare system, and personal costs for patients. Smoking cessation in COPD patients is known to improve survival and reduce the number of AECOPD. However, smoking cessation interventions in these patients have only been successful for consistent smoking abstinence in 12 months in approximately 15-20%. Thus, more effective interventions are needed for this patient group.

Aims:

The aim of this study is to determine, among people with chronic obstructive pulmonary disease (COPD), whether a "high-intensive" smoking cessation intervention in comparison to a standard intervention can lead to permanent, >12 months, smoking cessation in a higher proportion.

Methods:

This study is a randomized trial in active smokers with COPD and who have lost less than 50% lung function. A total of 600 participants will be randomly assigned 1:1 to either a standard treatment (guideline-based municipal smoking cessation programme, "low intensity" group), or an intervention group ("high-intensity" group), which consists of group sessions, telephone consultations, behavior design, hotline, "buddy-matching" (smoker matched with COPD patient who stopped). Both groups will receive pharmacological smoking cessation.

Discussion:

The potential benefit of this project is to prevent smoking-related exacerbations of COPD and thereby reduce logistics and costs of hospitalization and treatment of COPD. In addition, the project can potentially benefit from increasing the quality of life and longevity of COPD patients and reducing the risk of developing lung cancer and other smoking-related diseases.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pradeesh Sivapalan
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• Competent and mature

• Have diagnosed COPD [spirometry verified and evaluated by pulmonary specialist]

• Current daily smoker [Minimum 1 cigarette daily]

• Have smoked minimum 20 pack years (1 pack year = 20 cigarettes daily in 1 year)

• Want to or try to stop smoking

• Do not mind taking varenicline or NRT during the trial

• Are willing to give blood and urine samples according to the protocol

Exclusion Criteria:

• Previously included in the trial

• Hospitalized with COPD-exacerbation within the last 24 months

• Are associated with hospital outpatient clinic for COPD disease treatment

• Have FEV1<50%.

• Pregnancy/breastfeeding

• Life expectancy less than 1 year

• Severe linguistic problems or inability to give informed consent

• Severe mental illness that is not controlled with medication

• Active alcohol or substance abuse

• Active cancer disease* *The person can participate if he or she has had a cancer disease that is now referred to as curative/radically treated. Basal cell carcinoma of the skin does not count as an exclusion criterion.