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

NCT ID: NCT00132236

Last Updated: 2005-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2004-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Smoking COPD

Keywords

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smoking cessation nicotine sublingual tablets behaviour support smoking reduction quality of life COPD weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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nicotine sublingual tablets

Intervention Type DRUG

low and high behavior support

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Principal Investigators

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Philip Tønnesen, M.D., Ph.D.

Role: STUDY_CHAIR

Pulm. dept. Gentofte University Hospital

Locations

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Dept. pulm. medicine, Århus kommunehospital

Aarhus, , Denmark

Site Status

Dept. pulm. medicine, Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Dept of Pulm. medicine, Helsingør Sygehus

Elsinore, , Denmark

Site Status

Pulm. Dept., Frederiksberg Hospital

Frederiksberg, Copenhagen, , Denmark

Site Status

Pulm. Dept, Gentofte University Hospital

Hellerup, , Denmark

Site Status

Dept. pulm. medicine, Nykøbing Falster Sygehus

Nykøbing Falster, , Denmark

Site Status

Pulm. dept, Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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CTN980-CHC-9015-027

Identifier Type: -

Identifier Source: secondary_id

KA01096gms

Identifier Type: -

Identifier Source: org_study_id