Condition category
Respiratory
Date applied
28/04/2006
Date assigned
28/04/2006
Last edited
15/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daniel Kotz

ORCID ID

Contact details

University Maastricht (UM)
CAPHRI Research Institute
Department of General Practice
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3882893
d.kotz@hag.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR627

Study information

Scientific title

Acronym

COSMO

Study hypothesis

Confrontation with the results from spirometry as part of counselling for smoking cessation in smokers with not earlier diagnosed mild to moderate COPD is effective with regard to prolonged abstinence from smoking during a period of 12 months.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Tobacco addiction, chronic obstructive pulmonary disease (COPD)

Intervention

Intervention groups:
1. Confrontational counselling delivered by a pulmonary nurse and pharmacotherapy
2. Health education and promotion delivered by a pulmonary nurse and pharmacotherapy
3. 'Care as usual' delivered by the general practitioner

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome of this study is biochemically validated prolonged abstinence from smoking during a period of 12 months. A smoker is defined as prolonged abstinent if he/she is a non-smoker (no cigarette smoked during the preceding seven days), at the end of the intervention (day 50), and at the follow-up visits after 6 months (day 197) and 12 months (day 380). Non-smoking is verified by urine cotinine. Participants with a cotinine-value of >50 ng/ml are regarded as smokers as well as participants who are lost to follow-up.

Secondary outcome measures

1. Point prevalence of non-smokers (no cigarette smoked during the preceding seven days) at the end of the intervention period and at 6- and 12-month follow-up
2. Self-reported number of quit attempts and temporary or complete relapse
3. Attitudes, social norms and self-efficacy with regard to smoking cessation
4. Lung function (FEV1 post-bronchodilatory and FEV1/FVC) at baseline and at 12-month follow-up
5. Anthropometry: physical height and weight at baseline, at the end of the intervention period and at 6- and 12-month follow-up
6. Perceived specific health-related complaints (impairments and functional disabilities in everyday life)
7. Health-related quality of life
8. Mental health (fear, depression)
9. Smoking related cognitions (risk perception, health concerns, self-exempting beliefs)
10. Number of unplanned visits to the general practitioner or specialized physician due to respiratory complaints and the number, severity and frequency of exacerbations (self-reported and/or reported by the general practitioner or specialist)

Overall trial start date

01/02/2004

Overall trial end date

01/02/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 35 through 70 years
2. Smoker with a smoking history of >10 pack years of cigarettes
3. Motivated to stop smoking
4. One or more of the following symptoms are present: cough, progressive persistent shortness of breath (worse during exercise or respiratory infections) or sputum production
5. Bronchus obstruction detected by spirometry: FEV1/FVC-ratio <70% and postbronchodilatory FEV1 >50% predicted (= mild or moderate COPD/GOLD I or II)
6. Competent enough in speaking the Dutch language

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

350

Participant exclusion criteria

1. Known by the general practitioner or in the second-line medical care with the diagnosis asthma or COPD (e.g. chronic bronchitis, lung emphysema)
2. Spirometry performed during the preceding 12 months
3. FEV1 <50% predicted (= severe or very severe COPD/GOLD III or IV)
4. Contraindications for the intake of the medication such as an acute myocardial infarction and hypersensitiveness for nortriptyline
5. Current use of antidepressants
6. Quit smoking attempt(s) using nortriptyline or bupropion during the preceding 6 months
7. Co-morbidity: hypersensitiveness towards nortriptyline, tuberculosis, porfyrine, epilepsy, Parkinson's disease, glaucoma, bronchial carcinoma or any other live threatening disease

Recruitment start date

01/02/2004

Recruitment end date

01/02/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Maastricht (UM)
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

University Maastricht (UM), CAPHRI Research Institute (The Netherlands)

Sponsor details

P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3882446
e.habets@caphri.unimaas.nl

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Hospital Maastricht (AZM) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Partners in Care Solutions (PICASSO) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Asthma Foundation (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20538445

Publication citations

  1. Results

    Reda AA, Kotz D, Kocks JW, Wesseling G, van Schayck CP, Reliability and validity of the clinical COPD questionniare and chronic respiratory questionnaire., Respir Med, 2010, 104, 11, 1675-1682, doi: 10.1016/j.rmed.2010.04.023.

Additional files

Editorial Notes