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

October 20, 2005 updated by: University Hospital, Gentofte, Copenhagen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
smoking cessation after 6 and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Study Completion

June 1, 2004

Study Registration Dates

First Submitted

August 17, 2005

First Submitted That Met QC Criteria

August 17, 2005

First Posted (Estimate)

August 19, 2005

Study Record Updates

Last Update Posted (Estimate)

October 21, 2005

Last Update Submitted That Met QC Criteria

October 20, 2005

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KA01096gms
  • CTN980-CHC-9015-027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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