Status:
WITHDRAWN
TOBacco STOP in Chronic Obstructive Pulmonary Disease-Trial - Study Protocol
Lead Sponsor:
Pradeesh Sivapalan
Conditions:
Chronic Obstructive Pulmonary Disease
Smoking Cessation
Eligibility:
All Genders
50+ years
Phase:
PHASE4
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 (A...
Detailed Description
Hypothesis: A "high-intensity" smoking cessation intervention is superior in leading to permanent (\>12 months) smoking cessation in active smokers with COPD than does a standard, guideline-based mun...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04088942
Start Date
July 1 2023
End Date
January 1 2026
Last Update
February 23 2023
Active Locations (4)
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1
Bispebjerg University Hospital
Copenhagen, Denmark
2
Hvidovre University Hospital
Copenhagen, Denmark
3
North Zealand Hospital
Copenhagen, Denmark
4
Department of Internal medicine, Herlev & Gentofte Universtity Hospital
Hellerup, Denmark, 2900