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

University Hospital, Gentofte, Copenhagen

Status and phase: Terminated; Phase 3

Conditions: COPD; Smoking

Treatments: Drug: nicotine sublingual tablets; Behavioral: low and high behavior support

Study type: Interventional

Funder types: Other

Identifiers

NCT00132236

CTN980-CHC-9015-027

KA01096gms

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind