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

This study has been terminated.
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00132236
First received: August 17, 2005
Last updated: October 20, 2005
Last verified: July 2005
History of Changes

August 17, 2005
October 20, 2005
February 2002
Not Provided
smoking cessation after 6 and 12 months
Same as current
Complete list of historical versions of study NCT00132236 on ClinicalTrials.gov Archive Site
  • smoking reduction after 12 months
  • change in quality of life (St. George Respiratory Questionnaire)
  • smoking reduction after 12 months
  • change in quality of life (St George Respiratory Quest.)
Not Provided
Not Provided
 
Nurse Smoking Cessation of Patients With Chronic Obstructive Pulmonary Disease (COPD) With Nicotine Replacement Therapy (NRT) and Behavioral Support
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Smoking
  • COPD
  • Drug: nicotine sublingual tablets
  • Behavioral: low and high behavior support
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
300
June 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00132236
KA01096gms, CTN980-CHC-9015-027
Not Provided
Not Provided
University Hospital, Gentofte, Copenhagen
Not Provided
Study Chair: Philip Tønnesen, M.D., Ph.D. Pulm. dept. Gentofte University Hospital
University Hospital, Gentofte, Copenhagen
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP