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Effects of a reduction-to-quit smoking programme in patients with COPD: the REDUQ study.

A randomised controlled trial with 18 months follow-up in COPD patients comparing a smoking reduction programme with a self-help intervention, on reduction followed by sustained cessation.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24119
Enrollment
262
Registered
2010-02-25
Start date
2010-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease COPD Lung emphysema and chronic bronchitis Smoking Tobacco addiction Nicotine dependence Smoking cessation Smoking reduction

Interventions

Intervention arm (Reduction-to-Quit Smoking Intervention): Patients in the intervention group receive an intensive reduction-to-quit smoking programme, which combines behavioural counselling with ni

Sponsors

University of Twente, Dept. Psychology & Communication of Health & Risk; Depts Pulmonolgy of University Medical Center Groningen, Slotervaart Hospital, Catharina Hospital and Medisch Spectrum Twente
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. COPD, GOLD stage I-IV; 2. Age 40-80 years; 3. Smoking 10 or more cigarettes daily; 4. Motivated to reduce smoking; 5. 2 failed lifetime quit attempts (abstinence > 24 hours)

Exclusion criteria

Exclusion criteria: 1. Motivated to quit smoking within 1 month from baseline (= ready to quit); 2. Not able to speak, read and write Dutch; 3. Contra-indication for the use of NRT; 4. Serious psychiatric morbidity (not only depressive symptoms); 5. Pregnancy.

Design outcomes

Primary

MeasureTime frame
The primary outcome parameter is the percentage of patients with continuous cotinine-validated abstinence after two years from baseline, for at least the last full year. Continuous abstinence is defined as having salivary cotinine levels < 20ng/mL at measurements at 12 and 24 months.

Secondary

MeasureTime frame
1. Smoking reduction / decrease of the daily cigarette consumption; 2. Behavioural prognostic determinants of smoking reduction and cessation (e.g. attitude, self-efficacy, nicotine dependence); 3. Point prevalence abstinence rates at 12, 18, and 24 months; 4. Disease-specific QoL; 5. Lung function (FEV1, IVC, FEV1/IVC, FEV1% predicted); 6. Frequency and severity of exacerbations; 7. Disease-specific symptoms (breathlessness, coughing, sputum production); 8. Motivation/readiness to quit smoking; 9. Cost-effectiveness data.

Contacts

Public ContactMarcel Pieterse

University of Twente, building citadel, P.O.Box 217

m.e.pieterse@utwente.nl+31 (0)53 4896066

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)