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

NCT04088942 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-02-23

No results posted yet for this study

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.

Conditions

Interventions

OTHER

High-intensity smoking cessation intervention

1. Varenicline for 12 weeks - Day 1-3: 0.5 mg daily. Dag 4-7: 0.5 mg two times daily. Thereafter 1 mg 2 times daily. 2. Group-sessions in 6 months: Preparation phase: 5 sessions Day 1-14: 5 sessions Day 15-30: 5 sessions Day 31-60: 5 sessions Day 61-90: 5 sessions Day 90-180: 5 sessions c) Hotline and scheduled phone consultations: 1. A hotline is established which the high-intensity group can call. 2. Weekly calls to all patients in the project for 26 weeks. Call for 5-10 min. If the patient has not had relapse, there will be called week 34 and week 42. If the patient has had relapse, calls continue until relapse-free for 10 weeks, then week 34 and week 42. d) Buddy-arrangement: i. Patients who have completed the program and have become smoke-free, are matched with new ones in the program. A meeting frequency of approx. every 7-14 days. The first patients are matched with patients from pulmonary medical outpatient clinic who have ceased smoking.

DRUG

Low-intensity smoking cessation intervention

Varenicline prescribed for 12 weeks - Day 1-3: 0.5 mg daily. Dag 4-7: 0.5 mg two times daily. Thereafter 1 mg 2 times daily.

Sponsors & Collaborators

  • Pradeesh Sivapalan

    lead OTHER

Principal Investigators

  • Jens-Ulrik S Jensen, MD, PhD · Herlev-Gentofte Hospital, COP:TRIN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2026-01-01
Completion
2026-01-01

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04088942 on ClinicalTrials.gov