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

Purpose

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.

Condition	Intervention	Phase
Smoking COPD	Drug: nicotine sublingual tablets Behavioral: low and high behavior support	Phase III

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease) Quitting Smoking Smoking

Drug Information available for:

Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:

smoking cessation after 6 and 12 months

Secondary Outcome Measures:

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

Estimated Enrollment:	300
Study Start Date:	February 2002
Estimated Study Completion Date:	June 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00132236

Locations


Denmark
	Pulm. Dept, Gentofte University Hospital
	Hellerup, Denmark, 2900
	Dept of Pulm. medicine, Helsingør Sygehus
	Helsingør, Denmark
	Pulm. Dept., Frederiksberg Hospital
	Frederiksberg, Copenhagen, Denmark
	Dept. pulm. medicine, Nykøbing Falster Sygehus
	nykøbing Falster, Denmark
	Pulm. dept, Odense University Hospital
	Odense, Denmark
	Dept. pulm. medicine, Århus kommunehospital
	Aarhus, Denmark
	Dept. pulm. medicine, Bispebjerg Hospital
	Copenhagen, Denmark

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

Investigators


Study Chair:	Philip Tønnesen, M.D., Ph.D.	Pulm. dept. Gentofte University Hospital

More Information

Study ID Numbers:	KA01096gms, CTN980-CHC-9015-027
First Received:	August 17, 2005
Last Updated:	October 20, 2005
ClinicalTrials.gov Identifier:	NCT00132236
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by University Hospital, Gentofte, Copenhagen:

smoking cessation

nicotine sublingual tablets

behaviour support

smoking reduction

quality of life

COPD

weight

Smoking cessation

Study placed in the following topic categories:

Nicotine polacrilex

Body Weight

Smoking

Lung Diseases, Obstructive

Respiratory Tract Diseases

Nicotine

Lung Diseases

Quality of Life

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Habits

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Cholinergic Agonists

Autonomic Agents

Nicotinic Agonists

Physiological Effects of Drugs

Ganglionic Stimulants

Peripheral Nervous System Agents

Cholinergic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 05, 2008

Sponsored by:	University Hospital, Gentofte, Copenhagen
Information provided by:	University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT00132236