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

NCT04088942 | Withdrawn Phase 4 DMC

• 1 other identifier: Protocol_TOB-STOP-COP_MISJUJ
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief 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

Chronic Obstructive Pulmonary Disease; Smoking Cessation; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease; Randomized Controlled Trial; Smoking Cessation; Behavioural support; varenicline; exacerbations

Outcome Measures

Primary Outcomes (1)

• Anamnestic and biochemical* validated smoking cessation

  \*Cotinine is analyzed in a urine sample, as validated point-prevalence for the last 7 days

  12 months after inclusion

Secondary Outcomes (12)

• Number of admissions for exacerbations of COPD or death

  Within 12 months after inclusion

• Number of admissions for all causes or death

  Within 12 months after inclusion

• Number of cardiovascular events

  Within 12 months after inclusion

• Changes in CAT-score (COPD Assessment Test)

  12 months after inclusion

• Changes in FEV1 from baseline

  12 months after inclusion

Other Outcomes (3)

• Occurrence of depression

  Within 36 months after inclusion

• Number of days during antidepressant treatment

  36 months after inclusion

• Changes in FEV1

  36 months after inclusion

Study Arms (2)

High-intensity group

EXPERIMENTAL

Will receive "high-intensity" intervention, which is a combination of pharmacological (varenicline) and behavioural support, described later.

Other: High-intensity smoking cessation intervention

Low-intensity group

ACTIVE COMPARATOR

Encouraged to quit smoking via own doctor and is prescribed varenicline.

Drug: Low-intensity smoking cessation intervention

Interventions

High-intensity smoking cessation intervention OTHER

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.

High-intensity group

Low-intensity smoking cessation intervention DRUG

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.

Low-intensity group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pradeesh Sivapalan: lead

Study Sites (4)

Bispebjerg University Hospital

Copenhagen, Denmark

Location

Hvidovre University Hospital

Copenhagen, Denmark

Location

North Zealand Hospital

Copenhagen, Denmark

Location

Department of Internal medicine, Herlev & Gentofte Universtity Hospital

Hellerup, 2900, Denmark

Location

Related Publications (31)

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• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

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• Saeed MI, Sivapalan P, Eklof J, Ulrik CS, Pisinger C, Lapperre T, Tonnesen P, Hoyer N, Janner J, Karlsson ML, Bech CS, Marsa K, Godtfredsen N, Brondum E, Munk B, Raaschou M, Browatzski A, Lutken P, Jensen JS. 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 disease. Trials. 2020 Aug 21;21(1):730. doi: 10.1186/s13063-020-04653-z.

  PMID: 32825845 DERIVED

Related Links

• World Health Organization. Chronic obstructive pulmonary disease fact sheet.
• Danish Lung Association and www.lunge.dk. Key numbers on pulmonary diseases

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking Cessation; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Study Officials

• Jens-Ulrik S Jensen, MD, PhD

  Herlev-Gentofte Hospital, COP:TRIN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD student

Model Details: This study will be performed as a randomized, open label, superiority, 2-arm intervention study in active smokers with COPD. A total of 600 participants will be included with startup 1st January 2020 and is expected to be completed 3 years later, January 2023. Participants are randomized (random allocation) 1:1 to a "low-intensity group" and a "high-intensity group". Stratified for age (\>65 years vs. ≤65 years) and number of daily cigarettes (\>10/day vs. ≤10/day). Blocked randomization through REDCap with blocks of varying sizes (4-8), which will not be disclosed. Participants, their data and laboratory specimens etc. will be assigned a coded identification number (ID) to maintain participant confidentiality. Participants will be randomized to either a low-intensity or a high-intensity smoking cessation intervention.

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 13, 2019
• Study Start: July 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DK (4)