Nurse Smoking Cessation of Patients With Chronic Obstructive Pulmonary Disease (COPD) With Nicotine Replacement Therapy (NRT) and Behavioral Support

Phase 3

Terminated

• Conditions: Smoking; COPD

• Registration Number: NCT00132236
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

This is a smoking cessation study with COPD patients where the researchers wanted to evaluate if nicotine sublingual tablets or placebo combined with low or high individual support could increase ½ and 1 year quit rates.

Detailed Description

Placebo, controlled, randomized, double-blind trial with 400-1000 smoking COPD patients with FEV-1 \< 90 % predicted normal with the use of nicotine sublingual nicotine tablets or placebo for 12 weeks combined with individual clinic visits with low or high intensity conducted by trained nurses in several centres in pulmonary clinics in Denmark. Outcome was smoking cessation and smoking reduction after ½ and 1 year as self declared smoking status confirmed by carbon monoxide in expired air\< 10 ppm. Secondary outcomes were change in body-weight, quality of life (SF-36 and SGRQ), symptoms, lung function, adverse events.

Study Timeline

• Study Start: 2002-02
• Study Completion: 2004-06
• Status Verified: 2005-07
• Study First Submitted: 2005-08-17
• Study First Submitted QC: 2005-08-17
• Study First Posted: 2005-08-19
• Last Update Submitted: 2005-10-20
• Last Update Posted: 2005-10-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• COPD patients (FEV1/FVC<70% and FEV1<90 % predicted)
• Smoking 1 cigarette daily or more
• Willing to follow the protocol

Exclusion Criteria

• Used NRT or bupropion the last week
• Not able or willing to adhere to the protocol
• Estimated survival < 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
smoking cessation after 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
smoking reduction after 12 months
change in quality of life (St. George Respiratory Questionnaire)

Trial Locations

Locations (7)

Pulm. Dept, Gentofte University Hospital; 🇩🇰 Hellerup, Denmark

Dept. pulm. medicine, Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Dept. pulm. medicine, Århus kommunehospital; 🇩🇰 Aarhus, Denmark

Pulm. Dept., Frederiksberg Hospital; 🇩🇰 Frederiksberg, Copenhagen, Denmark

Dept of Pulm. medicine, Helsingør Sygehus; 🇩🇰 Helsingør, Denmark

Dept. pulm. medicine, Nykøbing Falster Sygehus; 🇩🇰 nykøbing Falster, Denmark

Pulm. dept, Odense University Hospital; 🇩🇰 Odense, Denmark