NCT04088942: TOB-STOP-COP

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

Withdrawn Phase 4 Last updated 23 February 2023

What this trial tests

Phase 4 trial testing High-intensity smoking cessation intervention in Chronic Obstructive Pulmonary Disease. Withdrawn.

Timeline

1 July 2023

Primary endpoint
1 January 2026

1 January 2026

Quick facts

Lead sponsor	Pradeesh Sivapalan
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 July 2023
Primary completion	1 January 2026
Estimated completion	1 January 2026
Sites	4 locations across Denmark

Drugs / interventions tested

• High-intensity smoking cessation intervention
• Low-intensity smoking cessation intervention — full drug profile →

Conditions studied

• Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →
• Smoking Cessation — all drugs for Smoking Cessation →
• Lung Diseases, Obstructive — all drugs for Lung Diseases, Obstructive →
• Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

Pradeesh Sivapalan — full company profile →

Who can join

50 and older, any sex, with Chronic Obstructive Pulmonary Disease or Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for preventing weight gain after smoking cessation.
   Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, et al · · 2021 · cited 40× · PMID 34611902 · DOI 10.1002/14651858.cd006219.pub4
2. TOB-STOP-COP (TOBacco STOP in COPd trial): study protocol-a randomized open-label, superiority, multicenter, two-arm intervention study of the effect of "high-intensity" vs. "low-intensity" smoking cessation intervention in active smokers with chronic obstructive pulmonary diseas
   Saeed MI, Sivapalan P, Eklöf J, Ulrik CS, et al · · 2020 · cited 3× · PMID 32825845 · DOI 10.1186/s13063-020-04653-z