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

COPD Clinical Trial

Official title:

Smoking Cessation of Patients With COPD: A Multi-Center, Randomized, Placebo Controlled Nurse Conducted Smoking Cessation Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00132236
• Other study ID #: KA01096gms
• Secondary ID: CTN980-CHC-9015-
• Status: Terminated
• Phase: Phase 3
• First received: August 17, 2005
• Last updated: October 20, 2005
• Start date: February 2002
• Est. completion date: June 2004

Study information

• Verified date: July 2005
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive
• Smoking

Intervention

Drug:
• nicotine sublingual tablets

Behavioral:
• low and high behavior support

Locations

Country	Name	City	State
Denmark	Dept. pulm. medicine, Århus kommunehospital	Aarhus
Denmark	Dept. pulm. medicine, Bispebjerg Hospital	Copenhagen
Denmark	Pulm. Dept., Frederiksberg Hospital	Frederiksberg, Copenhagen
Denmark	Pulm. Dept, Gentofte University Hospital	Hellerup
Denmark	Dept of Pulm. medicine, Helsingør Sygehus	Helsingør
Denmark	Dept. pulm. medicine, Nykøbing Falster Sygehus	nykøbing Falster
Denmark	Pulm. dept, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking cessation after 6 and 12 months
Secondary	smoking reduction after 12 months
Secondary	change in quality of life (St. George Respiratory Questionnaire)