NCT00132236

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2002

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
Last Updated

October 21, 2005

Status Verified

July 1, 2005

First QC Date

August 17, 2005

Last Update Submit

October 20, 2005

Conditions

SmokingCOPD

Keywords

smoking cessationnicotine sublingual tabletsbehaviour supportsmoking reductionquality of lifeCOPDweight

Outcome Measures

Primary Outcomes (1)

  • smoking cessation after 6 and 12 months

Secondary Outcomes (2)

  • smoking reduction after 12 months

  • change in quality of life (St. George Respiratory Questionnaire)

Interventions

nicotine sublingual tabletsDRUG
low and high behavior supportBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Dept. pulm. medicine, Århus kommunehospital

Aarhus, Denmark

Location

Dept. pulm. medicine, Bispebjerg Hospital

Copenhagen, Denmark

Location

Dept of Pulm. medicine, Helsingør Sygehus

Elsinore, Denmark

Location

Pulm. Dept., Frederiksberg Hospital

Frederiksberg, Copenhagen, Denmark

Location

Pulm. Dept, Gentofte University Hospital

Hellerup, 2900, Denmark

Location

Dept. pulm. medicine, Nykøbing Falster Sygehus

Nykøbing Falster, Denmark

Location

Pulm. dept, Odense University Hospital

Odense, Denmark

Location

MeSH Terms

Conditions

SmokingPulmonary Disease, Chronic ObstructiveSmoking CessationSmoking ReductionBody Weight

Condition Hierarchy (Ancestors)

BehaviorLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHealth BehaviorSigns and Symptoms

Study Officials

  • Philip Tønnesen, M.D., Ph.D.

    Pulm. dept. Gentofte University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2005

First Posted

August 19, 2005

Study Start

February 1, 2002

Study Completion

June 1, 2004

Last Updated

October 21, 2005

Record last verified: 2005-07

Locations

DK(7)